Assyro AI

Orange Book product · Brand (NDA)

FORZINITY

ELAMIPRETIDE HYDROCHLORIDE

Brand (NDA)NDA 215244RX STEALTH BIOTHERAPS

At a glance

Sep 19, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

6

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 19, 2025

    9 mo ago

  2. Today

  3. Patent 7576061 expires

    Listed drug substance patent expiration.

    Jan 20, 2027

    in 7 mo

  4. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Sep 19, 2030

    in 4 yr 4 mo

  5. Exclusivity ends · ODE-551

    Orphan-drug exclusivity (7 years)

    Sep 19, 2032

    in 6 yr 4 mo

  6. Patent 11083771 expires

    Listed method-of-use patent (U-4277) expiration.

    Feb 28, 2034

    in 7 yr 10 mo

  7. Patent 11083772 expires

    Listed method-of-use patent (U-4277) expiration.

    Feb 28, 2034

    in 7 yr 10 mo

  8. Patent 11771734 expires

    Listed method-of-use patent (U-4277) expiration.

    Feb 28, 2034

    in 7 yr 10 mo

  9. Patent 12268724 expires

    Listed method-of-use patent (U-4277) expiration.

    Feb 28, 2034

    in 7 yr 10 mo

  10. Patent 9687519 expires

    Listed method-of-use patent (U-4277) expiration.

    Feb 28, 2034

    in 7 yr 10 mo

Pharmaceutical detail

Active ingredient

ELAMIPRETIDE HYDROCHLORIDE

Strength

EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 215244

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Sep 19, 2030

    in 4 yr 4 mo

  • ODE-551Orphan-drug exclusivity (7 years)

    Sep 19, 2032

    in 6 yr 4 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7576061Jan 20, 2027in 7 mo
SubstanceProduct
11083771Feb 28, 2034in 7 yr 10 mo
U-4277
11083772Feb 28, 2034in 7 yr 10 mo
U-4277
11771734Feb 28, 2034in 7 yr 10 mo
U-4277
12268724Feb 28, 2034in 7 yr 10 mo
U-4277
9687519Feb 28, 2034in 7 yr 10 mo
U-4277
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.