| Mayne Pharma Inc |
68308066830 |
Doxycycline 40mg Capsules 30 count |
Generic |
FDA |
2023-02-23 |
782.6200 |
None |
1 |
17000 |
None |
None |
None |
None |
None |
None |
The 17,000 estimated number of patients is per month and on a national level. |
None |
| Mayne Pharma Inc |
68308066510 |
Calcitriol Ointment 3mcg/g 100g |
Generic |
FDA |
2023-07-27 |
823.3100 |
None |
1 |
1800 |
None |
None |
2023-07-18 |
0.0000 |
1 |
There was no upfront cost for the license of this product. |
The 1800 estimated number of patients is per month and on a national level. |
None |
| Mayne Pharma Inc |
68308076950 |
Halobetasol Propionate Topical Foam, 0.05% 50g |
Generic |
FDA |
2023-12-08 |
828.5200 |
None |
1 |
6700000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Meitheal Pharmaceuticals, Inc. |
71288013951 |
Mitomycin for Injection, USP 40mg 100mL SDV |
Generic |
FDA |
2023-03-14 |
1263.9600 |
Meitheal markets generic Mitomycin for Injection 40mg as a therapeutic equivalent to the innovator (brand) drug in the U.S. As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the innovator drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
90550 |
None |
None |
None |
None |
None |
None |
Since Mitomycin for Injection is a generic product that has a few alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Mitomycin for Injection. Mitomycin for Injection is primarily used for the treatment of cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy. The website Cancer.org states a patient population of 90,550 stomach or pancreas cancer patients on an annual basis. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=672 |
| Meitheal Pharmaceuticals, Inc. |
71288010320 |
Bendamustine HCl for Injection, USP 100 mg 20 mL SDV |
Generic |
FDA |
2023-06-14 |
1600.0000 |
Meitheal markets generic Bendamustine HCl as a therapeutic equivalent to Cephalon's NDA# 022249 Treanda for Injection (marketed by Teva). As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the reference listed drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
18740 |
None |
None |
None |
None |
None |
None |
As Bendamustine is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Bendamustine. As such, given Bendamustine primary use for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, Meitheal's best estimate regarding a patient population is 18,740 new cases of CLL and 80,550 people diagnosed with NHL in the US per American Cancer Society's estimates for the US in 2023. |
https://reports.siera.hcai.ca.gov/api/report/drug-pricing/attachment?id=683 |
| Meitheal Pharmaceuticals, Inc. |
71288015501 |
Plerixafor Injection, 24 mg per 1.2 mL (20mg/mL) SDV |
Generic |
FDA |
2023-07-26 |
1490.5000 |
Meitheal markets generic Plerixafor Injection as a therapeutic equivalent to Genzyme's NDA#022311 Mozobil (marketed by Sanofi). As such, Meitheal relies on the safety and efficacy findings of the FDA with respect to the reference listed drug. Meitheal markets to group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), and hospital/alternate site (own use) customers based solely on price and availability and therefore does not engage in direct-to-consumer, direct-to-physician, or prescriber marketing. Meitheal does not market based on any aspects of the drug itself, nor does Meitheal aim to treat a certain number of patients. Rather, Meitheal evaluates the size of the total market for a particular drug and strives to achieve a certain market share for that product. |
None |
22827 |
None |
None |
None |
None |
None |
None |
As Plerixafor product is a generic product and there are a number of alternative options available, Meitheal Pharmaceuticals does not track the number of patients that are prescribed Plerixafor. As such, given Plerixafor injection is used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma (NHL) or multiple myeloma, Meitheal's best estimate regarding a patient population is 7,722 transplants for multiple myeloma and 3,184 transplants for NHL per Center for International Blood and Marrow Transplant Research (CIBMTR). |
None |
| Melinta Therapeutics, LLC |
70842024001 |
REZZAYO packaged with 1 VIAL in 1 CARTON / one 200 MG INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Brand |
FDA |
2023-07-31 |
1950.0000 |
None |
1 |
200000 |
None |
1 |
2022-07-27 |
0.0000 |
1 |
The information is not publicly available. |
Rezzayo was granted Orphan Drug status by the FDA. To qualify for Orphan Drug designation, the number of people affected by the disease or condition for which the drug is to be developed is fewer than 200,000 persons. |
None |
| Mylan Pharmaceuticals Inc |
00378193501 |
Lenalidomide 2.5mg Oral capsule, 100 |
Generic |
FDA |
2023-03-07 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378193528 |
Lenalidomide 2.5mg Oral capsule, 28 |
Generic |
FDA |
2023-03-07 |
20157.3600 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194201 |
Lenalidomide 20mg Oral capsule, 100 |
Generic |
FDA |
2023-03-07 |
71990.6200 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
00378194221 |
Lenalidomide 20mg Oral capsule, 21 |
Generic |
FDA |
2023-03-07 |
15118.0400 |
None |
1 |
70792 |
None |
None |
None |
None |
None |
None |
The Product was not the result of a product acquisition.
Lenalidomide is indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, follicular lymphoma, and marginal zone lymphoma. Based on the literature, an estimated 34,470 adults in the United States will be diagnosed with multiple myeloma (https://www.cancer.net/cancer-types/multiple-myeloma/statistics), and approximately 10,000 people in the United States are diagnosed with MDS each year (https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics). In 2020, about 77,240 new cases of non-Hodgkin lymphoma (NHL) were expected to be diagnosed in the US. MCL patients represent about 3 to 8 percent of all new cases of NHL (https://www.lls.org/sites/default/files/2021-09/FS4_Mantle_Cell_Facts_0921Rev.pdf). Follicular lymphoma has an annual incidence of about 15,000 cases/year in the United States (https://www.lls.org/research/follicular-lymphoma-fl). In 2016, there were an estimated 7,460 newly diagnosed patients with marginal zone lymphoma (MZL) in the US (https://aol.amegroups.com/article/view/6993/html).Therefore, an estimated (using available data) 70,792 patients in the United States could potentially use this product during the current year. |
None |
| Mylan Pharmaceuticals Inc |
49502038102 |
Hulio®(CF) (adalimumab-fkjp) Injection 20 mg/0.4 mL Syringe |
Generic |
FDA |
2023-07-06 |
6576.4900 |
None |
1 |
12957128 |
None |
1 |
None |
None |
None |
None |
HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain |
None |
| Mylan Pharmaceuticals Inc |
49502038202 |
Hulio®(CF) (adalimumab-fkjp) Injection 40 mg/0.8 mL Syringe |
Generic |
FDA |
2023-07-06 |
6576.4900 |
None |
1 |
12957128 |
None |
1 |
None |
None |
None |
None |
HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain |
None |
| Mylan Pharmaceuticals Inc |
49502038002 |
Hulio®(CF) (adalimumab-fkjp) Pen Injection 40 mg/0.8 mL |
Generic |
FDA |
2023-07-06 |
6576.4900 |
None |
1 |
12957128 |
None |
1 |
None |
None |
None |
None |
HULIO injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of HULIO.
HULIO injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of HULIO.
HULIO injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of HULIO.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologics"), creating what Viatris expects to be a unique fully vertically integrated global biosimilars leader. Viatris and Biocon Biologics have entered a Transition Services Agreement (TSA) pursuant to which Viatris will provide commercialization and certain |
None |
| Mylan Pharmaceuticals Inc |
49502041702 |
Adalimumab-fkjp(CF) Injection 20 mg/0.4 mL Syringe |
Generic |
FDA |
2023-07-07 |
995.0000 |
None |
1 |
12957128 |
None |
None |
None |
None |
None |
None |
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologic |
None |
| Mylan Pharmaceuticals Inc |
49502041802 |
Adalimumab-fkjp(CF) Injection 40 mg/0.8 mL Syringe |
Generic |
FDA |
2023-07-07 |
995.0000 |
None |
1 |
12957128 |
None |
None |
None |
None |
None |
None |
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologic |
None |
| Mylan Pharmaceuticals Inc |
49502041602 |
Adalimumab-fkjp(CF) Pen Injection 40 mg/0.8 mL |
Generic |
FDA |
2023-07-07 |
995.0000 |
None |
1 |
12957128 |
None |
None |
None |
None |
None |
None |
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with moderate to severe rheumatoid arthritis (RA). Based on trusted literature, an estimated 1.3 million adults in the United States have moderate to severe RA (https://www.medicalnewstoday.com/articles/rheumatoid-arthritis-prevalence#causes). In the United States, there are currently 258 million adults over the age of 18, meaning an estimated .6% to 1% of the American adult population has moderate to severe RA. Therefore, using available data, approximately 1.3 million patients with RA in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms of moderate to severe juvenile idiopathic arthritis (JIA). JIA is the most common chronic rheumatologic disorder amongst juveniles in the United States (https://www.arthritis.org/diseases/juvenile-idiopathic-arthritis). Based on trusted literature, the prevalence of JIA ranges from 16-50 cases/100,000 individuals in the United States (https://posna.org/physician-education/study-guide/juvenile-idiopathic-arthritis). Therefore, there is an estimated total of 294,000 juveniles affected by moderate to severe JIA in the United States that could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active psoriatic arthritis. Based on trusted literature, an estimated 1.5 million adults in the United States have active psoriatic arthritis (https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/). It is estimated that about one in three adults with the skin disease psoriasis will get psoriatic arthritis. Therefore, using available data, approximately 1.5 million adult patients with psoriatic arthritis in the United States could be eligible for use of Adalimumab.
Adalimumab injections are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). Based on trusted literature, the prevalence of active AS in the United States is approximately 0.2 – 0.5% (https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/#:~:text=Epidemiology,14%20per%20100%2C000%20person%2Dyears.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately to 670,256 to 1.67 million Americans with active AS could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active Crohn’s disease in adults and pediatric patients 6 years of age or older. Based on trusted literature, there are an estimated 565,000 Americans living with moderate to severe Crohn’s disease (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 565,000 people in the United States with active Crohn’s disease could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe active ulcerative colitis in adult patients. Based on trusted literature, there are an estimated 593,000 Americans living with moderate to severe ulcerative colitis (https://pubmed.ncbi.nlm.nih.gov/22926499/). Therefore, approximately 593,000 people in the United States with active ulcerative colitis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis. Based on trusted literature, an estimated range of 1-2% of the American population lives with moderate to severe plaque psoriasis (https://emedicine.medscape.com/article/1108072-overview). Plaque psoriasis is the most common form of psoriasis and affects 80-90% of psoriasis patients (https://my.clevelandclinic.org/health/diseases/22842-plaque-psoriasis#:~:text=How%20common%20is%20plaque%20psoriasis,with%20psoriasis%20have%20plaque%20psoriasis.). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, approximately 3.35 to 6.7 million people in the United States with chronic plaque psoriasis could be eligible for use of Adalimumab.
Adalimumab injections are indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. Based on trusted literature, an estimated .1% of the American population is affected by moderate to severe HS (https://pubmed.ncbi.nlm.nih.gov/28492923/). In the United States, there are currently 335,128,200 people (https://www.census.gov/popclock/). Therefore, an estimated 335,128 people in the United States with moderate to severe HS could be eligible for use of Adalimumab.
Therefore, an estimated (using available data) 12,957,128 patients in the United States could potentially use this product during the current year.
The Products were not the result of a product acquisition; however, on November 29, 2022, Viatris announced that it has closed its transaction with Biocon Biologics Limited ("Biocon Biologic |
None |
| Mylan Pharmaceuticals Inc |
00378381601 |
Clozapine Orally Disintegrating Tablets, 150mg, 100 PKG |
Generic |
FDA |
2023-08-16 |
1726.3200 |
None |
1 |
167686 |
None |
None |
None |
None |
None |
None |
Clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, treatment-resistant schizophrenia occurs in up to 34% of patients with schizophrenia (https://www.nature.com/articles/s41537-019-0090-z#:~:text=Treatment-resistant%20schizophrenia%20(TRS)%20has%20been%20defined%20). Therefore, approximately 1,140,262 patients living with treatment-resistant schizophrenia could be eligible for use of clozapine orally disintegrating tablets.
Clozapine orally disintegrating tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia who are judged to be at chronic risk of re-experiencing suicidal behavior. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, the risk of suicidal behavior among individuals with schizophrenia is estimated at 5% (https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/3632-schizophrenia-bipolar-disorder-and-suicide). Therefore, approximately 167,686 patients with recurrent suicidal behavior could be eligible for use of clozapine orally disintegrating tablets. |
None |
| Mylan Pharmaceuticals Inc |
00378381701 |
Clozapine Orally Disintegrating Tablets, 200mg, 100 PKG |
Generic |
FDA |
2023-08-16 |
2301.7700 |
None |
1 |
167686 |
None |
None |
None |
None |
None |
None |
Clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, treatment-resistant schizophrenia occurs in up to 34% of patients with schizophrenia (https://www.nature.com/articles/s41537-019-0090-z#:~:text=Treatment-resistant%20schizophrenia%20(TRS)%20has%20been%20defined%20). Therefore, approximately 1,140,262 patients living with treatment-resistant schizophrenia could be eligible for use of clozapine orally disintegrating tablets.
Clozapine orally disintegrating tablets are indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia who are judged to be at chronic risk of re-experiencing suicidal behavior. Based on trusted literature, an estimated 1% of Americans are affected by schizophrenia (https://www.hopkinsmedicine.org/health/wellness-and-prevention/mental-health-disorder-statistics). In the United States, there are currently 335,371,100 people (https://www.census.gov/popclock/). Thus, an estimated 3,353,711 Americans are affected by schizophrenia. According to literature, the risk of suicidal behavior among individuals with schizophrenia is estimated at 5% (https://www.treatmentadvocacycenter.org/evidence-and-research/learn-more-about/3632-schizophrenia-bipolar-disorder-and-suicide). Therefore, approximately 167,686 patients with recurrent suicidal behavior could be eligible for use of clozapine orally disintegrating tablets. |
None |