Details for New Drug Application (NDA): 215244
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NDA 215244 describes FORZINITY, which is a drug marketed by Stealth Biotheraps and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the FORZINITY profile page.
The generic ingredient in FORZINITY is elamipretide hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elamipretide hydrochloride profile page.
The generic ingredient in FORZINITY is elamipretide hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elamipretide hydrochloride profile page.
Summary for 215244
| Tradename: | FORZINITY |
| Applicant: | Stealth Biotheraps |
| Ingredient: | elamipretide hydrochloride |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215244
Generic Entry Date for 215244*:
Constraining patent/regulatory exclusivity:
TO IMPROVE MUSCLE STRENGTH IN ADULT AND PEDIATRIC PATIENTS WITH BARTH SYNDROME WEIGHING AT LEAST 30 KG Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 215244
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FORZINITY | elamipretide hydrochloride | SOLUTION;SUBCUTANEOUS | 215244 | NDA | Stealth Biotherapeutics Inc. | 72507-800 | 72507-800-04 | 4 VIAL in 1 CARTON (72507-800-04) / 3.5 mL in 1 VIAL (72507-800-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | ||||
| Approval Date: | Sep 19, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 19, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 19, 2032 | ||||||||
| Regulatory Exclusivity Use: | TO IMPROVE MUSCLE STRENGTH IN ADULT AND PEDIATRIC PATIENTS WITH BARTH SYNDROME WEIGHING AT LEAST 30 KG | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 28, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG | ||||||||
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