Forzinity is a drug owned by Stealth Biotherapeutics Inc. It is protected by 6 US drug patents filed in 2025 out of which none have expired yet. Forzinity's patents will be open to challenges from 19 September, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 28, 2034. Details of Forzinity's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7576061 | NA |
Jan, 2026
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12268724 | NA |
Feb, 2034
(8 years from now) | Active |
| US11771734 | NA |
Feb, 2034
(8 years from now) | Active |
| US11083772 | NA |
Feb, 2034
(8 years from now) | Active |
| US11083771 | NA |
Feb, 2034
(8 years from now) | Active |
| US9687519 | NA |
Feb, 2034
(8 years from now) | Active |
FDA has granted several exclusivities to Forzinity. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Forzinity, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Forzinity.
Exclusivity Information
Forzinity holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Forzinity's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 19, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Forzinity is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Forzinity's family patents as well as insights into
ongoing legal events
on those patents.
Forzinity's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Forzinity's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 28, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Forzinity Generics:
There are no approved generic versions for Forzinity as of now.
About Forzinity
Forzinity is a drug owned by Stealth Biotherapeutics Inc. Forzinity uses Elamipretide Hydrochloride as an active ingredient. Forzinity was launched by Stealth Biotheraps in 2025.
Approval Date:
Forzinity was approved by FDA for market use on 19 September, 2025.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Forzinity is 19 September, 2025, its NCE-1 date is estimated to be 19 September, 2029.
Active Ingredient:
Forzinity uses Elamipretide Hydrochloride as the active ingredient. Check out other Drugs and Companies using Elamipretide Hydrochloride ingredient
Dosage:
Forzinity is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |