Assyro AI

Orange Book product · Brand (NDA)

MOUNJARO

TIRZEPATIDE

Brand (NDA)NDA 215866RX ELI LILLY AND CO

At a glance

Jul 28, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

28

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 28, 2023

    2 yr 11 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    May 13, 2027

    in 11 mo

  4. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Dec 19, 2028

    in 2 yr 6 mo

  5. Patent 9474780 expires

    Listed drug substance patent expiration.

    Jan 05, 2036

    in 9 yr 8 mo

  6. Patent 11357820 expires

    Listed drug substance patent expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  7. Patent 12453755 expires

    Listed method-of-use patent (U-4386) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  8. Patent 12453755 expires

    Listed method-of-use patent (U-4380) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  9. Patent 12453755 expires

    Listed method-of-use patent (U-4383) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  10. Patent 12453755 expires

    Listed method-of-use patent (U-4378) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  11. Patent 12453755 expires

    Listed method-of-use patent (U-4375) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  12. Patent 12453755 expires

    Listed method-of-use patent (U-4385) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  13. Patent 12453755 expires

    Listed method-of-use patent (U-4384) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  14. Patent 12453755 expires

    Listed method-of-use patent (U-4376) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  15. Patent 12453755 expires

    Listed method-of-use patent (U-4382) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  16. Patent 12453755 expires

    Listed method-of-use patent (U-4379) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  17. Patent 12453755 expires

    Listed method-of-use patent (U-4381) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  18. Patent 12453755 expires

    Listed method-of-use patent (U-4377) expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  19. Patent 12453756 expires

    Listed drug product patent expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  20. Patent 12629404 expires

    Listed drug product patent expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  21. Patent 12629404 expires

    Listed drug product patent expiration.

    Jun 14, 2039

    in 13 yr 2 mo

  22. Patent 12343382 expires

    Listed method-of-use patent (U-4229) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  23. Patent 12343382 expires

    Listed method-of-use patent (U-4230) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  24. Patent 12343382 expires

    Listed method-of-use patent (U-4231) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  25. Patent 12343382 expires

    Listed method-of-use patent (U-4232) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  26. Patent 12343382 expires

    Listed method-of-use patent (U-4401) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  27. Patent 12343382 expires

    Listed method-of-use patent (U-4400) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  28. Patent 12616740 expires

    Listed method-of-use patent (U-4500) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  29. Patent 12616740 expires

    Listed method-of-use patent (U-4501) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  30. Patent 12616740 expires

    Listed method-of-use patent (U-4502) expiration.

    Jul 22, 2039

    in 13 yr 3 mo

  31. Patent 12295987 expires

    Listed method-of-use patent (U-4193) expiration.

    Dec 30, 2041

    in 15 yr 9 mo

  32. Patent 12295987 expires

    Listed method-of-use patent (U-4192) expiration.

    Dec 30, 2041

    in 15 yr 9 mo

Pharmaceutical detail

Active ingredient

TIRZEPATIDE

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 215866

Product number

007

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)

    May 13, 2027

    in 11 mo

  • NPPNew patient population exclusivity (3 years)

    Dec 19, 2028

    in 2 yr 6 mo

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9474780Jan 05, 2036in 9 yr 8 mo
SubstanceProductU-4374
11357820Jun 14, 2039in 13 yr 2 mo
SubstanceProduct
12453755Jun 14, 2039in 13 yr 2 mo
U-4386
12453755Jun 14, 2039in 13 yr 2 mo
U-4380
12453755Jun 14, 2039in 13 yr 2 mo
U-4383
12453755Jun 14, 2039in 13 yr 2 mo
U-4378
12453755Jun 14, 2039in 13 yr 2 mo
U-4375
12453755Jun 14, 2039in 13 yr 2 mo
U-4385
12453755Jun 14, 2039in 13 yr 2 mo
U-4384
12453755Jun 14, 2039in 13 yr 2 mo
U-4376
12453755Jun 14, 2039in 13 yr 2 mo
U-4382
12453755Jun 14, 2039in 13 yr 2 mo
U-4379
12453755Jun 14, 2039in 13 yr 2 mo
U-4381
12453755Jun 14, 2039in 13 yr 2 mo
U-4377
12453756Jun 14, 2039in 13 yr 2 mo
Product
12629404Jun 14, 2039in 13 yr 2 mo
ProductU-4533
12629404Jun 14, 2039in 13 yr 2 mo
ProductU-4534
12343382Jul 22, 2039in 13 yr 3 mo
U-4229
12343382Jul 22, 2039in 13 yr 3 mo
U-4230
12343382Jul 22, 2039in 13 yr 3 mo
U-4231
12343382Jul 22, 2039in 13 yr 3 mo
U-4232
12343382Jul 22, 2039in 13 yr 3 mo
U-4401
12343382Jul 22, 2039in 13 yr 3 mo
U-4400
12616740Jul 22, 2039in 13 yr 3 mo
U-4500
12616740Jul 22, 2039in 13 yr 3 mo
U-4501
12616740Jul 22, 2039in 13 yr 3 mo
U-4502
12295987Dec 30, 2041in 15 yr 9 mo
U-4193
12295987Dec 30, 2041in 15 yr 9 mo
U-4192
Agent CTA Background

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