| Dash Pharmaceuticals, LLC |
69339013012 |
Zileuton ER Tablets |
2021-01-04 |
3222.0400 |
This product will only be marketed in the US. DASH plans to sell this product to major wholesale distributors at a price that is competitive with the other AB Rated Zileuton generic products currently in the marketplace. |
None |
6829 |
None |
None |
2021-01-04 |
None |
1 |
DASH is selling under a licensing agreement from the manufacturer. There was no licensing fee, just a profit split in the marketing arrangement. |
None |
None |
| Dash Pharmaceuticals, LLC |
69339014819 |
Sucralfate Oral Suspension |
2021-02-25 |
899.7000 |
Product will be priced competitively with other equivalent generics currently in the marketplace. |
None |
134 |
None |
None |
None |
None |
None |
None |
None |
None |
| Dr. Reddy's Laboratories, Inc. |
43598065101 |
Vigabatrin Tablets USP 500mg US 100s |
2021-02-01 |
10511.8900 |
None |
1 |
400000 |
None |
1 |
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. However, Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its Vigabatrin Tablet 500MG product given, among other things, (i) the unknown size of the prospective patient population meeting the relevant criteria; (ii) Vigabatrin tablets dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution). Because of the risk of vision loss, Vigabatrin should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious.(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. In any event, roughly 400,000 people living in the United States are likely to have refractory epilepsy. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598047730 |
Sapropterin Dihydrochloride Sachets, 100 mg, 30 ct |
2021-04-06 |
870.4800 |
None |
1 |
19000 |
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 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 sachets 100mg 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. |
43598045202 |
Albendazole Tabs USP 200mg US 2s |
2021-04-28 |
80.0000 |
None |
1 |
1300 |
None |
None |
None |
None |
None |
None |
1) Though the WAC is only $80 per package, the drug exceeds the threshold based on monthly usage. 2) Dr. Reddy’s did not acquire the product |
None |
| Dr. Reddy's Laboratories, Inc. |
43598090158 |
Ertapenem for Injection 1g per vial,10s |
2021-05-10 |
1000.0000 |
None |
1 |
250000 |
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. Dr. Reddy’s lacks sufficient information to determine the total number of patients who may be prescribed its 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. However, we listed the number of cases of pyelonephritis in the US, which is one of the conditions this product treats, for reference. 2) Dr. Reddy’s did not acquire the product; Dr. Reddy’s is, however, licensing the product for commercialization from Gland Pharma Ltd. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598062857 |
Carmustine for Injection, USP 100mg/vial |
2021-10-14 |
750.0000 |
None |
1 |
700000 |
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. The patient size provided is the number of Americans with brain tumor, which this chemotherapy drug is used to treat. 2) Dr. Reddy’s did not acquire the product as this product is a DRL-owned ANDA. |
None |
| Dr. Reddy's Laboratories, Inc. |
43598047611 |
Daptomycin for Injection, 350mg/vial |
2021-10-14 |
40.0000 |
None |
1 |
165000 |
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. The estimate provided is based on the incidence rate of staphylococcus aureus bacteremia in the US, which this drug is used to treat. 2. Dr. Reddy’s did not acquire the product as this product is a DRL-owned ANDA.3. Although the WAC per package is only $40, the monthly course of therapy exceeds the threshold of $670. |
None |