ELAMIPRETIDE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for elamipretide hydrochloride and what is the scope of freedom to operate?
Elamipretide hydrochloride
is the generic ingredient in one branded drug marketed by Stealth Biotheraps and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elamipretide hydrochloride has eighty-five patent family members in thirteen countries.
One supplier is listed for this compound.
Summary for ELAMIPRETIDE HYDROCHLORIDE
| International Patents: | 85 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 17 |
| Patent Applications: | 52 |
| What excipients (inactive ingredients) are in ELAMIPRETIDE HYDROCHLORIDE? | ELAMIPRETIDE HYDROCHLORIDE excipients list |
| DailyMed Link: | ELAMIPRETIDE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ELAMIPRETIDE HYDROCHLORIDE
Generic Entry Date for ELAMIPRETIDE HYDROCHLORIDE*:
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.
Recent Clinical Trials for ELAMIPRETIDE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stealth BioTherapeutics Inc. | PHASE2 |
| David Marcinek | PHASE2 |
| Stealth BioTherapeutics Inc. | PHASE3 |
US Patents and Regulatory Information for ELAMIPRETIDE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stealth Biotheraps | FORZINITY | elamipretide hydrochloride | SOLUTION;SUBCUTANEOUS | 215244-001 | Sep 19, 2025 | RX | Yes | Yes | 11,083,772 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Stealth Biotheraps | FORZINITY | elamipretide hydrochloride | SOLUTION;SUBCUTANEOUS | 215244-001 | Sep 19, 2025 | RX | Yes | Yes | 11,771,734 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Stealth Biotheraps | FORZINITY | elamipretide hydrochloride | SOLUTION;SUBCUTANEOUS | 215244-001 | Sep 19, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Stealth Biotheraps | FORZINITY | elamipretide hydrochloride | SOLUTION;SUBCUTANEOUS | 215244-001 | Sep 19, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Stealth Biotheraps | FORZINITY | elamipretide hydrochloride | SOLUTION;SUBCUTANEOUS | 215244-001 | Sep 19, 2025 | RX | Yes | Yes | 9,687,519 | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ELAMIPRETIDE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2916880 | ⤷ Start Trial | |
| Canada | 2916884 | ⤷ Start Trial | |
| Canada | 2916977 | ⤷ Start Trial | |
| China | 105407906 | ⤷ Start Trial | |
| China | 105517533 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
