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Orange Book drug · Brand (NDA)

Mounjaro

Tirzepatide

RLDNDA 215866 12 strengths Eli Lilly And Co
Approved
Jul 28, 2023
Strengths
12
Listed patents
8

What does the FDA Orange Book show for Mounjaro?

Mounjaro contains Tirzepatide and is the new drug FDA Orange Book record for NDA 215866. The application has 12 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 215866

New drug application identity from the Orange Book snapshot.

Application holder
Eli Lilly And Co

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
12

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
8

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
2

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0072.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0085MG/0.5ML (5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
0097.5MG/0.5ML (7.5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01010MG/0.5ML (10MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01112.5MG/0.5ML (12.5MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01215MG/0.5ML (15MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01310MG/2.4ML (4.17MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01420MG/2.4ML (8.33MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01530MG/2.4ML (12.5MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01640MG/2.4ML (16.7MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01750MG/2.4ML (20.8MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
01860MG/2.4ML (25MG/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Eli Lilly And Co

The Orange Book identifies this organization as the applicant responsible for NDA 215866.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

12 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

8 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Dec 30, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 1 other NDA found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 215866 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Subcutaneous

Tirzepatide

2 applications
Product rows
48
Active applications
2
Active with AB row
0
Zepbound · NDA 217806

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-215866

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

12 approved presentations · NDA 215866
RLDRS
Strength
2.5MG/0.5ML (2.5MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    3 yr ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 10 mo

  4. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 2 yr 5 mo

  5. Patent 9474780 expires

    Listed drug substance patent expiration.

    in 9 yr 7 mo

  6. Patent 11357820 expires

    Listed drug substance patent expiration.

    in 13 yr 1 mo

  7. Patent 12453755 expires

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

    in 13 yr 1 mo

  8. Patent 12453755 expires

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

    in 13 yr 1 mo

  9. Patent 12453755 expires

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

    in 13 yr 1 mo

  10. Patent 12453755 expires

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

    in 13 yr 1 mo

  11. Patent 12453755 expires

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

    in 13 yr 1 mo

  12. Patent 12453755 expires

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

    in 13 yr 1 mo

  13. Patent 12453755 expires

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

    in 13 yr 1 mo

  14. Patent 12453755 expires

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

    in 13 yr 1 mo

  15. Patent 12453755 expires

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

    in 13 yr 1 mo

  16. Patent 12453755 expires

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

    in 13 yr 1 mo

  17. Patent 12453755 expires

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

    in 13 yr 1 mo

  18. Patent 12453755 expires

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

    in 13 yr 1 mo

  19. Patent 12453756 expires

    Listed drug product patent expiration.

    in 13 yr 1 mo

  20. Patent 12629404 expires

    Listed drug product patent expiration.

    in 13 yr 1 mo

  21. Patent 12629404 expires

    Listed drug product patent expiration.

    in 13 yr 1 mo

  22. Patent 12343382 expires

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

    in 13 yr 2 mo

  23. Patent 12343382 expires

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

    in 13 yr 2 mo

  24. Patent 12343382 expires

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

    in 13 yr 2 mo

  25. Patent 12343382 expires

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

    in 13 yr 2 mo

  26. Patent 12343382 expires

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

    in 13 yr 2 mo

  27. Patent 12343382 expires

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

    in 13 yr 2 mo

  28. Patent 12616740 expires

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

    in 13 yr 2 mo

  29. Patent 12616740 expires

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

    in 13 yr 2 mo

  30. Patent 12616740 expires

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

    in 13 yr 2 mo

  31. Patent 12295987 expires

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

    in 15 yr 8 mo

  32. Patent 12295987 expires

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

    in 15 yr 8 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity NCE: 2027-05-13Exclusivity NCEExclusivity NPP: 2028-12-19Exclusivity NPPPatent 9474780: 2036-01-05Patent 9474780Patent 11357820: 2039-06-14Patent 11357820Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453755: 2039-06-14Patent 12453755Patent 12453756: 2039-06-14Patent 12453756Patent 12629404: 2039-06-14Patent 12629404Patent 12629404: 2039-06-14Patent 12629404Patent 12343382: 2039-07-22Patent 12343382Patent 12343382: 2039-07-22Patent 12343382Patent 12343382: 2039-07-22Patent 12343382Patent 12343382: 2039-07-22Patent 12343382Patent 12343382: 2039-07-22Patent 12343382Patent 12343382: 2039-07-22Patent 12343382Patent 12616740: 2039-07-22Patent 12616740Patent 12616740: 2039-07-22Patent 12616740Patent 12616740: 2039-07-22Patent 12616740Patent 12295987: 2041-12-30Patent 12295987Patent 12295987: 2041-12-30Patent 12295987
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

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

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    in 10 mo

  • NPPNew patient population exclusivity (3 years)

    in 2 yr 5 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9474780in 9 yr 7 mo
SubstanceProductU-4374
11357820in 13 yr 1 mo
SubstanceProduct
12453755in 13 yr 1 mo
U-4386
12453755in 13 yr 1 mo
U-4380
12453755in 13 yr 1 mo
U-4383
12453755in 13 yr 1 mo
U-4378
12453755in 13 yr 1 mo
U-4375
12453755in 13 yr 1 mo
U-4385
12453755in 13 yr 1 mo
U-4384
12453755in 13 yr 1 mo
U-4376
12453755in 13 yr 1 mo
U-4382
12453755in 13 yr 1 mo
U-4379
12453755in 13 yr 1 mo
U-4381
12453755in 13 yr 1 mo
U-4377
12453756in 13 yr 1 mo
Product
12629404in 13 yr 1 mo
ProductU-4533
12629404in 13 yr 1 mo
ProductU-4534
12343382in 13 yr 2 mo
U-4229
12343382in 13 yr 2 mo
U-4230
12343382in 13 yr 2 mo
U-4231
12343382in 13 yr 2 mo
U-4232
12343382in 13 yr 2 mo
U-4401
12343382in 13 yr 2 mo
U-4400
12616740in 13 yr 2 mo
U-4500
12616740in 13 yr 2 mo
U-4501
12616740in 13 yr 2 mo
U-4502
12295987in 15 yr 8 mo
U-4193
12295987in 15 yr 8 mo
U-4192

Active-ingredient family

Brand + generics

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

View full Tirzepatide family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Mounjaro: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 215866 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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