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Tirzepatide Patent Expiration

Tirzepatide is Used for long-term weight management in adults who are overweight or obese with at least one weight-related comorbid condition. It was first introduced by Eli Lilly And Co in its drug Mounjaro (Autoinjector) on May 13, 2022. Other drugs containing Tirzepatide are Mounjaro Kwikpen, Zepbound, Zepbound Kwikpen, Zepbound (Autoinjector), Mounjaro.


Tirzepatide Patents

Given below is the list of patents protecting Tirzepatide, along with the drug name that holds that patent and the company name owning that drug.

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Country : United States (US)
Patent Category : All
Dosage Form Category : Others
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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Mounjaro US12295987 Method of using a GIP/GLP1 co-agonist for diabetes Dec 30, 2041 Eli Lilly And Co
Mounjaro (autoinjector) US12295987 Method of using a GIP/GLP1 co-agonist for diabetes Dec 30, 2041 Eli Lilly And Co
Mounjaro Kwikpen US12295987 Method of using a GIP/GLP1 co-agonist for diabetes Dec 30, 2041 Eli Lilly And Co
Mounjaro US12343382 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Mounjaro US12616740 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Mounjaro (autoinjector) US12343382 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Mounjaro (autoinjector) US12616740 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Mounjaro Kwikpen US12343382 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Mounjaro Kwikpen US12616740 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Zepbound US12343382 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Zepbound US12453758 Method Of Using A Gip/Glp1 Co-Agonist For Diabetes Jul 22, 2039 Eli Lilly And Co
Zepbound US12616740 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Zepbound (autoinjector) US12343382 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Zepbound (autoinjector) US12453758 Method Of Using A Gip/Glp1 Co-Agonist For Diabetes Jul 22, 2039 Eli Lilly And Co
Zepbound (autoinjector) US12616740 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Zepbound Kwikpen US12343382 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Zepbound Kwikpen US12453758 Method Of Using A Gip/Glp1 Co-Agonist For Diabetes Jul 22, 2039 Eli Lilly And Co
Zepbound Kwikpen US12616740 Methods Of Using A Gip/Glp1 Co-Agonist For Therapy Jul 22, 2039 Eli Lilly And Co
Mounjaro US11357820 GIP/GLP1 agonist compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro US12453755 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro US12453756 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro US12629404 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro (autoinjector) US11357820 GIP/GLP1 agonist compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro (autoinjector) US12453755 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro (autoinjector) US12453756 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro (autoinjector) US12629404 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Zepbound US11357820 GIP/GLP1 agonist compositions Jun 14, 2039 Eli Lilly And Co
Zepbound US11918623 GIP/GLP1 agonist compositions Jun 14, 2039 Eli Lilly And Co
Zepbound US12453756 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Zepbound US12629404 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Zepbound (autoinjector) US11357820 GIP/GLP1 agonist compositions Jun 14, 2039 Eli Lilly And Co
Zepbound (autoinjector) US11918623 GIP/GLP1 agonist compositions Jun 14, 2039 Eli Lilly And Co
Zepbound (autoinjector) US12453756 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Zepbound (autoinjector) US12629404 Gip/Glp1 Agonist Compositions Jun 14, 2039 Eli Lilly And Co
Mounjaro US9474780 GIP and GLP-1 co-agonist compounds May 13, 2036 Eli Lilly And Co
Mounjaro (autoinjector) US9474780 GIP and GLP-1 co-agonist compounds May 13, 2036 Eli Lilly And Co
Mounjaro Kwikpen US9474780 GIP and GLP-1 co-agonist compounds May 13, 2036 Eli Lilly And Co
Zepbound US9474780 GIP and GLP-1 co-agonist compounds May 13, 2036 Eli Lilly And Co
Zepbound (autoinjector) US9474780 GIP and GLP-1 co-agonist compounds May 13, 2036 Eli Lilly And Co
Zepbound Kwikpen US9474780 GIP and GLP-1 co-agonist compounds May 13, 2036 Eli Lilly And Co
Mounjaro (autoinjector) US9402957 Automatic injection device with delay mechanism including dual functioning biasing member Jun 29, 2031 Eli Lilly And Co
Zepbound (autoinjector) US9402957 Automatic injection device with delay mechanism including dual functioning biasing member Jun 29, 2031 Eli Lilly And Co
Mounjaro (autoinjector) US8734394 Automatic injection device with delay mechanism including dual functioning biasing member Feb 24, 2031 Eli Lilly And Co
Zepbound (autoinjector) US8734394 Automatic injection device with delay mechanism including dual functioning biasing member Feb 24, 2031 Eli Lilly And Co



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tirzepatide's patents.

Given below is the list recent legal activities going on the following patents of Tirzepatide.

Activity Date Patent Number
Patent litigations
Email Notification 20 Dec, 2024 US11918623
Miscellaneous Communication to Applicant - No Action Count 19 Dec, 2024 US11918623
Mail Miscellaneous Communication to Applicant 19 Dec, 2024 US11918623
Patent eCofC Notification 19 Nov, 2024 US11918623
Email Notification 19 Nov, 2024 US11918623
Mail Patent eCofC Notification 19 Nov, 2024 US11918623
Recordation of Patent eCertificate of Correction 19 Nov, 2024 US11918623
Recordation of Patent eGrant 05 Mar, 2024 US11918623
Patent eGrant Notification 05 Mar, 2024 US11918623
Email Notification
Critical
05 Mar, 2024 US11918623


Tirzepatide's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tirzepatide:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Tirzepatide has 8 clinical trials that have been verified in 2024. Out of these 8, 1 trial is in PHASE4.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes Eli Lilly and Company NA COMPLETED
(Sep 1, 2026)
PHASE2
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE2
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes Novo Nordisk A/S NA COMPLETED
(Sep 1, 2026)
PHASE2
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE3
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE3
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE3
Tirzepatide for the Treatment of Cannabis Use Disorder Brigham and Women's Hospital NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Evaluate ALN-2232 in Participants With Obesity Alnylam Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Tirzepatide for Treatment of CCCA Johns Hopkins University NA RECRUITING
(Sep 1, 2026)
PHASE2
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS) Eli Lilly and Company NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Universidade do Porto NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus Arrowhead Pharmaceuticals NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD Regeneron Pharmaceuticals NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin CSPC Ouyi Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Tirzepatide in MetALD National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Jul 16, 2026)
PHASE2
A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Study of Tirzepatide for Recovery and Alcohol Use Management Brigham and Women's Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants Gan and Lee Pharmaceuticals, USA NA COMPLETED
(Jul 1, 2026)
PHASE2
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV University of Hawaii NA COMPLETED
(Jul 1, 2026)
PHASE2
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus Arrowhead Pharmaceuticals NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion Alaa Sada NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes Eli Lilly and Company NA COMPLETED
(Jun 1, 2026)
PHASE3
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight Eli Lilly and Company NA COMPLETED
(Jun 1, 2026)
PHASE3
Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease Washington University School of Medicine NA RECRUITING
(Jun 1, 2026)
PHASE2
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity St. Jude Children's Research Hospital NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study of SRSD384 in Overweight or Obese Participants Sirius Therapeutics Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity Eli Lilly and Company NA COMPLETED
(May 1, 2026)
PHASE2
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight Eli Lilly and Company NA COMPLETED
(May 1, 2026)
PHASE3
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight Eli Lilly and Company NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight Eli Lilly and Company NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer UNC Lineberger Comprehensive Cancer Center NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar McGill University Health Centre/Research Institute of the McGill University Health Centre NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) University of Virginia NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus Eli Lilly and Company NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight Novo Nordisk A/S NA COMPLETED
(Apr 1, 2026)
PHASE2
Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities Eli Lilly and Company NA COMPLETED
(Mar 1, 2026)
PHASE3
Trial of Tirzepatide for the Treatment of Cannabis Use Disorder National Institute on Drug Abuse (NIDA) NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes Eli Lilly and Company NA RECRUITING
(Sep, 2024)
PHASE2
A Study of LY3841136 in Overweight and Obese Participants Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Sep, 2024)
PHASE1
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH) Eli Lilly and Company NA COMPLETED
(Aug, 2024)
PHASE4
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity Eli Lilly and Company Regeneron Pharmaceuticals RECRUITING
(Aug, 2024)
PHASE2
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial Eli Lilly and Company NA COMPLETED
(Jul, 2024)
PHASE3
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Jul, 2024)
PHASE3
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) Eli Lilly and Company NA COMPLETED
(Apr, 2024)
PHASE2
Tirzepatide Monotherapy in Patients With Wolfram Syndrome Type 1 Ospedale San Raffaele NA RECRUITING
(Feb, 2024)
PHASE2
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes Eli Lilly and Company NA COMPLETED
(Jun, 2022)
PHASE1
A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Eli Lilly and Company NA COMPLETED
(Jan, 2022)
PHASE3


Tirzepatide Generic API Manufacturers

Given below is the list of companies who have filed for Tirzepatide generic, along with the locations of their manufacturing plants worldwide.


Tirzepatide News

Impact of Patent Expiration: Eli Lilly Faces Market Share Decline Amid Rise of Generic Weight-Loss Medications...

10 Apr, 2026

What Makes the First Oral Non-Peptide GLP-1 Agonist More Significant Than It Appears? | MEXC News

10 Apr, 2026

Generics of Semaglutide Capture 33% Market Share as India's GLP-1 Sector Evolves - TradingView

09 Apr, 2026

Generic versions of Semaglutide impact Mounjaro's sales and market presence following patent expiration | Industry Update

09 Apr, 2026

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