| Mylan Pharmaceuticals Inc |
00378713293 |
Erlotinib Hydrochloride Tablets, 100mg, 30s |
2019-05-09 |
6814.4800 |
None |
1 |
613554 |
None |
None |
None |
None |
None |
None |
According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not the result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378713393 |
Erlotinib Hydrochloride Tablets, 150mg, 30s |
2019-05-09 |
7707.6800 |
None |
1 |
613554 |
None |
None |
None |
None |
None |
None |
According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not the result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378427093 |
Ambrisentan Tablets, 5mg, 30s |
2019-05-07 |
1152.0400 |
None |
1 |
5270 |
None |
1 |
None |
None |
None |
None |
According to the American Lung Association, 15-50 people per million in the United States are affected by pulmonary arterial hypertension. This product was not the result of an acquisition. |
None |
| Mylan Institutional Inc |
42292005105 |
Erlotinib Hydrochloride Tablets, 25mg, Unit Dose, 20s |
2019-05-29 |
1654.0000 |
None |
1 |
540000 |
None |
None |
None |
None |
None |
None |
According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not a result of an acquisition. |
None |
| Mylan Institutional Inc |
42292005205 |
Erlotinib Hydrochloride Tablets, 100mg, Unit Dose, 20s |
2019-05-29 |
4542.9900 |
None |
1 |
540000 |
None |
None |
None |
None |
None |
None |
According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not a result of an acquisition. |
None |
| Mylan Institutional Inc |
42292005305 |
Erlotinib Hydrochloride Tablets, 150mg, Unit Dose, 20s |
2019-05-29 |
5138.4500 |
None |
1 |
540000 |
None |
None |
None |
None |
None |
None |
According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not a result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378427193 |
Ambrisentan Tablets, 10mg, 30s |
2019-05-07 |
1152.0400 |
None |
1 |
5270 |
None |
1 |
None |
None |
None |
None |
According to the American Lung Association, 15-50 people per million in the United States are affected by pulmonary arterial hypertension. This product was not the result of an acquisition. |
None |
| Mylan Institutional Inc |
67457096701 |
Hydroxyprogesterone Caproate 250mg/mL 1mL Injection 1PK |
2019-08-23 |
682.5500 |
None |
1 |
29011965 |
None |
1 |
None |
None |
None |
None |
Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation; therefore, the estimated number of patients has been calculated to include the total current population of the United States that may suffer from an indication and be prescribed this medication. In 2016, there were an estimated 772,245 women living with uterine cancer in the United States. [LINK] The prevalence of amenorrhea that is not due to pregnancy, lactation, or menopause is 3 to 4%. [LINK] Up to 14 percent of women experience irregular or excessively heavy menstrual bleeding. [LINK] Please note that Mylan did not acquire the ANDA within the meaning of Health and Safety Code (“HSC”) Section 127681(b)(4) and California Code of Regulations, Title 22, Section 96076(b)(4). Instead, Mylan executed a licensing agreement with the ANDA holder. This agreement, including the parties, terms, and financial arrangement, is confidential information that is not in the public domain or publicly available. As such, pursuant to HSC 127681(c) and California Code of Regulations, Title 22, Section 96076(c), the information in this report is limited to that which is otherwise in the public domain or publicly available. |
None |
| Mylan Institutional Inc |
67457031105 |
Fulvestrant 50mg/mL 5mL PFS 2PK |
2019-09-09 |
1745.1500 |
None |
1 |
179962 |
None |
1 |
None |
None |
None |
None |
Fulvestrant 50mg/mL 5mL Injection is indicated for (1) Monotherapy: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; and (2) Combination Therapy: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy, or HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (LINK) According to the National Institute of Cancer the total percentage of breast cancer that is the subtype HR+/HER2- is 67%. (LINK) Therefore, an estimated 179,962 (67% of 268,600) women in the United States may be prescribed the product. Note, there is difficultly in further defining a number of patients that may be prescribed as (1) the number of new cases state above includes both pre-menopausal (out of scope of indication) and post-menopausal women, and (2) does not account for how many may become post-menopausal during treatment or how many patients may be added year after year that may be in progression. The acquisition date and price fields are not applicable for this submission as the Product was not the result of an acquisition. |
https://oshpd.ca.gov/ml/v1/resources/document?rs:path=/Data-And-Reports/Documents/Topics/Cost-Transparency/Rx/Q3-New-Drug-Public-Release-Supporting-Documents/Mylan-Fulvestrant-FDA-Ack-Letter.pdf |
| Mylan Institutional Inc |
67457084744 |
Ogivri (trastuzumab-dkst) for Injection 420mg/vial, 1 vial |
2019-11-29 |
3697.2600 |
None |
1 |
40151 |
None |
None |
None |
None |
None |
None |
Ogivri is indicated for (1) Adjuvant Breast Cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, as part of a treatment regimen with docetaxel and carboplatin, or as a single agent following multi-modality anthracycline based therapy; (2) Metastatic Breast Cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.; and (3) Metastatic Gastric Cancer in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (LINK) According to the National Institute of Cancer, the total percentage of breast cancer that is the subtype HR+/HER2+ is 12.9%. (LINK) Therefore, an estimated 34,649 (12.9% of 268,600) women in the United States may be prescribed the product. In 2019, an estimated 27,510 new cases of gastric cancer are expected to be diagnosed in the U.S. (LINK) According to a 2017 study, gastric cancer that is the subset HER2-positive is 20% (LINK). Therefore, an estimated 5,502 (20% of 27,510) patients in the United States may be prescribed this product. Overall, a total of (34,649 HR+/HER2+ and 5,502 HER2+ gastric cancer patients = 40,151 estimated patients that may be prescribed the product in the US). |
None |
| Mylan Institutional Inc |
67457099115 |
Ogivri (trastuzumab-dkst) for Injection 150mg/vial, 1 vial |
2019-11-29 |
1324.6600 |
None |
1 |
40151 |
None |
None |
None |
None |
None |
None |
Ogivri is indicated for (1) Adjuvant Breast Cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, as part of a treatment regimen with docetaxel and carboplatin, or as a single agent following multi-modality anthracycline based therapy; (2) Metastatic Breast Cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.; and (3) Metastatic Gastric Cancer in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S. (LINK) According to the National Institute of Cancer, the total percentage of breast cancer that is the subtype HR+/HER2+ is 12.9%. (LINK) Therefore, an estimated 34,649 (12.9% of 268,600) women in the United States may be prescribed the product. In 2019, an estimated 27,510 new cases of gastric cancer are expected to be diagnosed in the U.S. (LINK) According to a 2017 study, gastric cancer that is the subset HER2-positive is 20% (LINK). Therefore, an estimated 5,502 (20% of 27,510) patients in the United States may be prescribed this product. Overall, a total of (34,649 HR+/HER2+ and 5,502 HER2+ gastric cancer patients = 40,151 estimated patients that may be prescribed the product in the US). |
None |
| Mylan Pharmaceuticals Inc |
00378713193 |
Erlotinib Hydrochloride Tablets, 25mg, 30s |
2019-05-09 |
2481.0000 |
None |
1 |
613554 |
None |
None |
None |
None |
None |
None |
According to the American Lung Association, approximately 540,000 living Americans have been diagnosed with lung cancer. Approximately 85 percent of those lung cancer cases are NSCLC. This product was not the result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378619793 |
Cinacalcet Hydrochloride Tablets, 30mg, 30s |
2019-05-23 |
685.7000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Approximately 30,000,000 people in the United States are living with chronic kidney disease, according to the American Kidney Fund. This product was not the result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378619693 |
Cinacalcet Hydrochloride Tablets, 60mg, 30s |
2019-05-23 |
1371.3900 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Approximately 30,000,000 people in the United States are living with chronic kidney disease, according to the American Kidney Fund. This product was not the result of an acquisition. |
None |
| Mylan Pharmaceuticals Inc |
00378619593 |
Cinacalcet Hydrochloride Tablets, 90mg, 30s |
2019-05-23 |
2057.0900 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Approximately 30,000,000 people in the United States are living with chronic kidney disease, according to the American Kidney Fund. This product was not the result of an acquisition. |
None |
| Mayne Pharma Inc |
51862060602 |
Halobetasol Propionate 0.05% Foam - Hydroalcoholic |
2019-01-14 |
1473.4600 |
None |
1 |
None |
None |
None |
2018-10-25 |
15000000.0000 |
None |
Total Halobetasol acquisition cost: $15million plus additional contingent earnout payments |
For additional information, please visit: https://www.maynepharma.com/media/2211/myx-announces-acquisition-of-fda-approved-halobetasol-foam.pdf *Please also be advised that the estimated number of patients is not currently reported as we do not have the full scope of this data yet |
None |
| Mayne Pharma Inc |
51862060650 |
Halobetasol Propionate 0.05% Foam - Hydroalcoholic |
2019-01-14 |
770.7200 |
None |
1 |
None |
None |
None |
2018-10-25 |
15000000.0000 |
None |
Total Halobetasol acquisition cost: $15million plus additional contingent earnout payments |
For additional information, please visit: https://www.maynepharma.com/media/2211/myx-announces-acquisition-of-fda-approved-halobetasol-foam.pdf *Please also be advised that the estimated number of patients is not currently reported as we do not have the full scope of this data yet |
None |
| Mayne Pharma Inc |
51862063428 |
Fentanyl Buccal 100mcg Tabs 28 |
2019-06-19 |
1300.5100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data. |
None |
| Mayne Pharma Inc |
51862063528 |
Fentanyl Buccal 200mcg Tabs 28 |
2019-06-19 |
1643.1400 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data. |
None |
| Mayne Pharma Inc |
51862063628 |
Fentanyl Buccal 400mcg Tabs 28 |
2019-06-19 |
2384.0600 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data. |
None |
| Mayne Pharma Inc |
51862063728 |
Fentanyl Buccal 600mcg Tabs 28 |
2019-06-19 |
3095.2100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data. |
None |
| Mayne Pharma Inc |
51862063828 |
Fentanyl Buccal 800mcg Tabs 28 |
2019-06-19 |
3813.1700 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
License deal June 2019. Please be advised that the number of patients reported is not reported as Mayne Pharma does not have this data. |
None |