| Deciphera Pharmaceuticals, LLC |
73207010130 |
Qinlock (ripretinib) 50mg |
2020-05-20 |
32000.0000 |
Marketing Plan in the U.S.
QINLOCK™ is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. For additional information about Qinlock, please see the full Prescribing Information, available at www.qinlock.com.
Qinlock will be marketed to healthcare professionals (HCPs) by a team of field-based professionals and its expenditures will include spending on the following areas.
Deciphera’s marketing initiatives will focus on raising awareness of this ultra-rare cancer, GIST, and its potential treatment. Supporting the launch of Qinlock may include comprehensive education and training initiatives that will be provided by Deciphera’s employees to HCPs about the approved indication, dosing administration, mechanism of action (MOA), efficacy and safety data contained within the FDA approved label. Deciphera will have available and provide to HCPs, various printed materials, patient brochures as well as offer peer to peer educational programs (in-person and virtual) depicting both the GIST disease state and the FDA-approved clinical profile of Qinlock. Additional activities may include the development of websites, webcasts, and other digital media offerings. Deciphera will participate in scientific meetings and congresses that will be attended by HCPs and may engage with HCPs through such attendance.
Pricing Plan in the U.S.
Deciphera is committed to ensuring patient access and the price for Qinlock was set after doing extensive research and understanding the value of Qinlock relative to other available treatments, as well as the unmet medical need, and disease burden of a gastrointestinal stromal tumor. Our research also entailed evaluating the competitive landscape, and payer environment, as well as business operational continuation needs. Deciphera is committed to supporting GIST patients and removing barriers to access. As part of that commitment, Deciphera has established Deciphera AccessPoint, a patient support program that provides reimbursement and financial assistance programs for eligible patients. |
None |
1100 |
1 |
1 |
None |
None |
None |
None |
Cal. Health & Safety Code §127681 does not currently define “release of the drug in the commercial market” and Deciphera is not aware of any guidance issued by California or any California regulation that defines “release of the drug in the commercial market” for the purpose of Cal. Health & Safety Code §127681. As a result, for the purposes of compliance with Cal. Health & Safety Code §127681, Deciphera considers a drug to be “release[d] . . . in the commercial market” when Deciphera makes product available for shipment to its Wholesalers, Specialty Pharmacies and other customers who purchase directly from Deciphera.
As authorized by Cal. Health & Safety Code §127681, this disclosure contains only information that Deciphera has identified as being in the public domain or publicly available.
Deciphera provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681 and its provisions. In providing this report, Deciphera does not waive any rights, claims, or legal challenges with respect to Cal. Health & Safety Code § 127681 and related legislation or any implementing regulations thereof. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598045901 |
Trientine Hydrochloride Capsules, USP 250 mg |
2020-02-06 |
5000.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
1) Although only about 2,000-3,000 cases have been diagnosed in the United States, other affected individuals may be misdiagnosed with other neurological, liver or psychiatric disorders. According to one estimate, there may actually be 9,000 people affected by Wilson’s disease in the United States. However, Trientine is used for a sub population of Wilson’s disease who are intolerant to penicillamine. We can therefore not be certain of the actual number of such patients. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
55111028960 |
Naproxen and Esomeprazole Magnesium 375-20mg Delayed-Release Tablet, 60 ct |
2020-02-26 |
1613.4300 |
None |
1 |
1300000 |
None |
None |
None |
None |
None |
None |
1) As this is a generic product, with other generics available, Dr. Reddy’s cannot estimate the estimated patient population. Notwithstanding, the total US patient population for rheumatoid arthritis is 1.3 million. However, Naproxen Esomeprazole is used for a sub population of patients who are at a high risk of stomach bleeding/ulcer. Indications of Naproxen Esomeprazole is also wider and can be substituted by taking the two products separately or even using OTC versions, so it is difficult to estimate the actual number. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
55111070160 |
Naproxen and Esomeprazole Magnesium 500-20mg Delayed-Release Tablet, 60 ct |
2020-02-26 |
1613.4300 |
None |
1 |
1300000 |
None |
None |
None |
None |
None |
None |
1) As this is a generic product, with other generics available, Dr. Reddy’s cannot estimate the estimated patient population. Notwithstanding, the total US patient population for rheumatoid arthritis is 1.3 million. However, Naproxen Esomeprazole is used for a sub population of patients who are at a high risk of stomach bleeding/ulcer. Indications of Naproxen Esomeprazole is also wider and can be substituted by taking the two products separately or even using OTC versions, so it is difficult to estimate the actual number. 2) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598067201 |
Pyrimethamine 25mg Tablet, USP 100ct |
2020-03-19 |
29250.0000 |
None |
1 |
4000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s Laboratories, Inc. did not acquire the product. 2) Between 400-4000 cases of toxoplasmosis are reported in the US each year. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Pyrimethamine given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) lack of data reported by the brand, which typically gives a leading indication to generic volume. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598089801 |
Amphetamine Sulfate 10mg Tablets,USP,100 ct |
2020-04-13 |
279.3000 |
None |
1 |
6300000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy's Laboratories, Inc. does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for ADHD and Narcolepsy, is approximately 6.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Amphetamine IR given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598089701 |
Amphetamine Sulfate 5mg Tablets,USP,100 ct |
2020-04-13 |
279.3000 |
None |
1 |
6300000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s Laboratories, Inc. does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for ADHD and Narcolepsy, is approximately 6.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Amphetamine IR given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598093109 |
Desmopressin Acetate Inj. USP 4mcg/mL, 10ct |
2020-05-05 |
380.0000 |
None |
1 |
33000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with other generics available. Notwithstanding, the total patient population for: Hemophilia A is approximately 33,000; Von Willebrand Disease is approximately 14,600; Diabetes Insipidus is approximately 13,000. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed Dr. Reddy’s Desmopressin Acetate Injection given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from SUNGEN. 3) Dr. Reddy’s Laboratories, Inc. does not believe this information is publicly available and has not released this information in the public domain. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598085230 |
Deferasirox Film Coated Tablets 180MG, 30ct |
2020-07-27 |
228.0400 |
None |
1 |
6700 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, the total prescriptions written for Deferasirox in a yearly basis is approximately 6,700. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Deferasirox FCT 180MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient.
2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from MSN Labs. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598063401 |
Penicillamine Oral Capsule 250 MG, 100 ct |
2020-08-26 |
8642.2500 |
None |
1 |
1344000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Penicillamine is indicated to treat is as follows: i) Wilson’s Disease – approximately 10,941 ii) Cystinuria – approximately 32,824; and iii) Rheumatoid Arthritis – approximately 1.3 million. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Penicillamine Oral Capsule 250MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. 3) Penicillamine was introduced to market on August 26, 2020. That is the date when the product was available for sale. The August 24, 2020 date in Medi-Span is simply the date that the WAC pricing was listed with the pricing compendia. However, for generic products, listing of the WAC does not trigger the statute as that date is not the date that the product is available for sale. For purchases of Penicillamine, the drug was not available for sale in California until August 26, 2020. This was the same date that was filed in our 3-day reports, as well as the reports submitted to other states under their drug price transparency statutes, as well as the date for purposes of computing government price reporting. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598026202 |
Fulvestrant Injection 250 mg/5 mL, 2ct |
2020-09-04 |
700.0000 |
None |
1 |
276480 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the American Cancer Society's estimates for breast cancer in the United States for 2020 approximately 276,480 new cases of invasive breast cancer will be diagnosed in women. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Fulvestrant Injection 250 mg/5 mL product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescription drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598043060 |
Dimethyl Fumarate Capsule 240mg 60ct |
2020-09-25 |
827.5900 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for MS, the condition that Dimethyl Fumarate is indicated to treat is 1 million patients. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Dimethyl Fumarate 240 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598067230 |
Pyrimethamine Tablets, USP 25mg, 30ct |
2020-09-26 |
8775.0000 |
None |
1 |
4000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for Toxoplasmosis, the condition that Pyrethamine is indicated to treat is 400 to 4000 cases per year. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Pyrimethamine Tablets, USP 25 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Pyrimethamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Cerovene. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598042952 |
Dimethyl Fumarate Capsule 120mg 14ct |
2020-09-28 |
193.1100 |
None |
1 |
1000000 |
None |
None |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for MS, the condition that Dimethyl Fumarate is indicated to treat is 1 million patients. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Dimethyl Fumarate 120 mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iii) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598074904 |
Sapropterin Dihydrochloride Tablets, 100 mg, 120ct |
2020-10-01 |
3868.8000 |
None |
1 |
19000 |
None |
1 |
None |
None |
None |
None |
1) Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Organization for Rare Disorders, the reported incidence of Phenylketonuria (PKU) from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the United States However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Sapropterin dihydrochloride tablets 100mg product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Penicillamine in rheumatoid arthritis patients should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. 2) Dr. Reddy’s did not acquire the product. Dr. Reddy’s is commercializing a limited supply of this product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598036930 |
Cinacalcet Oral Tablet 90 MG, 30 ct |
2020-10-27 |
292.5000 |
None |
1 |
537469 |
None |
None |
None |
None |
None |
None |
Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, the total prescriptions written for Cinacalcet Oral Tablet 90MG in a yearly basis is approximately 433,615 (including all strengths). As to number of patients: approximately 445,579 Adults may have CKD on dialysis that may present with Secondary HPT. Approximately 56 Adults may develop Parathyroid Carcinoma that may present with hypercalcemia. Approximately 91,834 Adults may have Primary HPT that may present with severe hypercalcemia and are unable to undergo a parathyroidectomy, thus a total of 537,469. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Cinacalcet Oral Tablet 90MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; and (ii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient. Dr. Reddy's did not acquire the product. The WAC, although less than $670, exceeds the threshold based on the monthly therapy usage. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598034431 |
Imatinib Mesylate Tablets 100mg, 30ct |
2020-10-27 |
875.0000 |
None |
1 |
35870 |
None |
None |
None |
None |
None |
None |
Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Imatinib Mesylate 100MG tablets is indicated to treat is as follows: 1) Philadelphia chromosome positive chronic myeloid leukemia approximately 19,940 individuals worldwide, 2) myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR(platelet-derived growth factor receptor) – approximately 10,000; and 3)Lymphoblastic lymphoma - approximately 5,930. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Imatinib Mesylate 100MG tablets product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Imatinib Mesylate in myeloid leukemia should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. Dr. Reddy's did not acquire the product. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598034531 |
Imatinib Mesylate Tablets 400mg, 30ct |
2020-10-27 |
2700.0000 |
None |
1 |
35870 |
None |
None |
None |
None |
None |
None |
Dr. Reddy’s does not track the estimated number of patients to be prescribed a drug on a monthly basis, due, among other reasons, to the fact that this is a generic product with numerous other generics available. Notwithstanding, according to the National Institute for Health, the estimated patient population for the conditions that Imatinib Mesylate 400mg tablets is indicated to treat is as follows: 1) Philadelphia chromosome positive chronic myeloid leukemia approximately 19,940 individuals worldwide, 2) myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR(platelet-derived growth factor receptor) – approximately 10,000; and 3)Lymphoblastic lymphoma - approximately 5,930. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Imatinib Mesylate 400MG tablets product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) use of Imatinib Mesylate in myeloid leukemia should be restricted to patients who have severe, active disease and who have failed to respond to other therapies; (iii) the current existence of numerous other prescription drugs with the same active pharmaceutical ingredient; and (iv) the existence of numerous other prescriptions drugs to treat these same conditions. Dr. Reddy's did not acquire the product. |
None |