Viewing data from:

MOUNJARO (AUTOINJECTOR)

NDA

TIRZEPATIDE | N215866 | ELI LILLY AND CO

24 strengths8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Active (8)TodayExclusivityIPRPTAB Challenge

2026

2027

2028

2029

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2031

2032

2033

2034

2035

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2039

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2042

Today

Jan. 5, 2036IPR×2

Jun. 14, 2039

Dec. 30, 2041

Jul. 22, 2039

Jun. 14, 2039

Jun. 14, 2039

Jul. 22, 2039

Jun. 14, 2039

NCE

May. 13, 2027

NPP

Dec. 19, 2028

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2025-01024	9474780	IPR	Empower Clinic Services, LLC. (d/b/a Empower Pharmacy)	Discretionary Denial	2025-05-22	2025-10-10
IPR2025-01346	9474780	IPR	BPI Labs, LLC et al.	Discretionary Denial	2025-08-04	2025-12-11

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

18 trials from ClinicalTrials.gov — 14 recruiting, 2 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities NCT06075667	Phase 3	Active	Eli Lilly and Company	160	2023-10-16 → 2029-07
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)NCT07417618	—	Active	Brigham and Women's Hospital	60,000	2026-01-27 → 2026-06-19
Assessing Biological Aging in a Real-World Medical Weight Loss Program Using the LinAge2 Clinical Clock NCT07444073	—	Not Yet Recruiting	National University of Singapore	440	2026-06-01 → 2027-12-31
Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial NCT07676331	Phase 2	Not Yet Recruiting	Universitaire Ziekenhuizen KU Leuven	168	2026-08-01 → 2028-05-01
Tirzepatide in the Treatment of Cannabis Use Disorder NCT07671248	Phase 3	Not Yet Recruiting	McMaster University	15	2026-08-01 → 2028-07-31
Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion NCT07573163	Phase 2	Not Yet Recruiting	Alaa Sada	34	2026-07 → 2028-12-31
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants NCT07671391	Phase 2	Not Yet Recruiting	Shanghai Zhongshan Hospital	60	2026-08 → 2027-12
GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity NCT07668765	—	Not Yet Recruiting	Gazi University	100	2026-08 → 2027-05
Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation NCT07387796	N/A	Recruiting	The University of Texas at Dallas	40	2026-06 → 2029-02
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight NCT06143956	Phase 2	Recruiting	Eli Lilly and Company	1,481	2023-11-17 → 2028-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Mounjaro (2023)

Total Spending

$2.4B

Total Claims

1,821,486

Beneficiaries

370,203

Avg Cost/Unit

$539.82

Spending Trend

$144.0M(2022)→$2.4B(2023)

YoY Change:+4.9%

5yr CAGR:+4.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain32 active DMFs

30 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDTIRZEPATIDE

DMF 387732023

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDTIRZEPATIDE

DMF 394652024

HARBIN JIXIANGLONG BIOTECH CO LTDTIRZEPATIDE

DMF 396112024

ZHEJIANG PEPTITES BIOTECH CO LTDTIRZEPATIDE

DMF 396552024

HANGZHOU THINHEAL PHARMA-TECH CO LTDTIRZEPATIDE

DMF 399002024

SICHUAN PUKANG PHARMACEUTICAL CO LTDTIRZEPATIDE SIDE CHAIN

DMF 399892024

SHENZHEN JYMED TECHNOLOGY CO LTDTIRZEPATIDE

DMF 401152024

APICORE US LLCTIRZEPATIDE

DMF 401232024

SHANGHAI JINGMAI PHARMACEUTICAL SCIENCE & TECHNOLOGY CO LTDTIRZEPATIDE

DMF 401662024

NANJING HANXIN PHARMACEUTICAL TECHNOLOGY CO LTDTIRZEPATIDE DRUG SUBSTANCE

DMF 403782024

HANGZHOU APEXTIDE BIOMEDICAL TECHNOLOGY CO LTDTIRZEPATIDE

DMF 404812024

SICHUAN QISHENG BIOMEDICAL TECHNOLOGY CO LTDTIRZEPATIDE

DMF 404952024

FUJIAN GENOHOPE BIOTECH LTDTIRZEPATIDE

DMF 405032024

SHENZHEN ALVANTIS PHARMA CO LTDTIRZEPATIDE

DMF 406682024

SUZHOU MOTIF BIOTECH CO LTDTIRZEPATIDE

DMF 410362025

SUZHOU RYWAY BIOTECH CO LTDTIRZEPATIDE

DMF 410662024

SHENZHEN READLINE BIOTECH CO LTDTIRZEPATIDE SIDE CHAIN

DMF 414612025

SICHUAN JISHENG BIOPHARMACEUTICAL CO LTDTIRZEPATIDE

DMF 415232025

NANJING CELLNUO BIOPHARMACEUTICAL CO LTDTIRZEPATIDE

DMF 416502025

HANGZHOU HOTIDE BIOTECH CO LTDTIRZEPATIDE

DMF 417442025

YANGZHOU AURISCO PHARMACEUTICAL CO LTDTIRZEPATIDE

DMF 418162025

NINGXIA LABSCHEM CO LTDTIRZEPATIDE

DMF 422592025

TAPI NL BVTIRZEPATIDE

DMF 423692025

CHENGDU SHENGNUO BIOPHARM CO LTDTIRZEPATIDE

DMF 424452025

ALLSINO PHARMACEUTICAL CO LTDTIRZEPATIDE SIDE CHAIN FRAGMENT

DMF 424482025

ALLSINO PHARMACEUTICAL CO LTDTIRZEPATIDE TETRAPEPTIDE FRAGMENT

DMF 424492025

ZHEJIANG PEPTITES BIOTECH CO LTDTIRZEPATIDE

DMF 429812025

GUIZHOU UTIDE BIOTECHNOLOGY CO LTDTIRZEPATIDE

DMF 429842025

BIOCON LTDTIRZEPATIDE

DMF 430382025

CHANGZHOU PHARMACEUTICAL FACTORYTIRZEPATIDE

DMF 431532025

SICHUAN DUORUI BIOPHARMACEUTICAL CO LTDTIRZEPATIDE

DMF 432572025

EL-PEPTIDO (SHANGHAI) BIOPHARMACEUTICAL CO LTDTIRZEPATIDE

DMF 434262025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jan 21, 2026	SUPPL -9	View Letter (PDF)
Jan 21, 2026	SUPPL -9	View Letter (PDF)
Jan 8, 2026	SUPPL -41	View Letter (PDF)
Dec 23, 2025	SUPPL -39	View Letter (PDF)
Sep 26, 2025	SUPPL -34	View Letter (PDF)
May 29, 2025	SUPPL -31	View Letter (PDF)
Nov 5, 2024	SUPPL -22	View Letter (PDF)
Nov 5, 2024	SUPPL -15	View Letter (PDF)
Nov 5, 2024	SUPPL -10	View Letter (PDF)
Jul 31, 2023	SUPPL -6	View Letter (PDF)
Jul 31, 2023	SUPPL -2	View Letter (PDF)
May 16, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (24)

Sort:

#007 — 2.5MG/0.5ML (2.5MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 28, 2023

#008 — 5MG/0.5ML (5MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 28, 2023

#009 — 7.5MG/0.5ML (7.5MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 28, 2023

#010 — 10MG/0.5ML (10MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 28, 2023

#011 — 12.5MG/0.5ML (12.5MG/0.5ML)

RLD

8 patents1 exclusivity▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 28, 2023

#012 — 15MG/0.5ML (15MG/0.5ML)

RLD

8 patents1 exclusivity▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 28, 2023

#013 — 10MG/2.4ML (4.17MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jan 7, 2026

#014 — 20MG/2.4ML (8.33MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jan 7, 2026

#015 — 30MG/2.4ML (12.5MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jan 7, 2026

#016 — 40MG/2.4ML (16.7MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jan 7, 2026

#017 — 50MG/2.4ML (20.8MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jan 7, 2026

#018 — 60MG/2.4ML (25MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jan 7, 2026

#001 — 2.5MG/0.5ML (2.5MG/0.5ML)

RLD

8 patents2 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: May 13, 2022

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9474780	Jan 5, 2036	—	Yes	Yes		—
11357820	Jun 14, 2039	—	—	Yes	—	—
12295987	Dec 30, 2041	—	—	—		—
12343382	Jul 22, 2039	—	—	—		—
12453755	Jun 14, 2039	—	—	—		—
12453756	Jun 14, 2039	—	—	Yes	—	—
12616740	Jul 22, 2039	—	—	—	U-4500	—
12629404	Jun 14, 2039	—	—	Yes	U-4533	—

Exclusivities (2)

Code	Date	Status
NCE	May 13, 2027	< 1 year
NPP	Dec 19, 2028	Active

#002 — 5MG/0.5ML (5MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: May 13, 2022

#003 — 7.5MG/0.5ML (7.5MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: May 13, 2022

#004 — 10MG/0.5ML (10MG/0.5ML)

RLD

8 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: May 13, 2022

#005 — 12.5MG/0.5ML (12.5MG/0.5ML)

RLD

8 patents1 exclusivity▾

SOLUTION;SUBCUTANEOUS | Approved: May 13, 2022

#006 — 15MG/0.5ML (15MG/0.5ML)

RLD

8 patents1 exclusivity▾

SOLUTION;SUBCUTANEOUS | Approved: May 13, 2022

#019 — 10MG/2.4ML (4.17MG/ML)

RLD

4 patents2 exclusivities▾