Details for New Drug Application (NDA): 215239
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NDA 215239 describes AGAMREE, which is a drug marketed by Catalyst Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the AGAMREE profile page.
The generic ingredient in AGAMREE is vamorolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vamorolone profile page.
The generic ingredient in AGAMREE is vamorolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vamorolone profile page.
Summary for 215239
| Tradename: | AGAMREE |
| Applicant: | Catalyst Pharms |
| Ingredient: | vamorolone |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215239
Generic Entry Date for 215239*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 215239
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AGAMREE | vamorolone | SUSPENSION;ORAL | 215239 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-264 | 69616-264-38 | 1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
| Approval Date: | Oct 26, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 26, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 26, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 28, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY | ||||||||
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