Baqsimi Patent Expiration

Baqsimi is a drug owned by Amphastar Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2019 to 2025. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 23, 2039. Details of Baqsimi's patents and their expiration are given in the table below.

Patent strength
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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10765602 Medication delivery systems and methods
Sep, 2039

(12 years from now)

Active
US10894133 Device for dispensing a fluid product
Jan, 2038

(11 years from now)

Active
US10213487 Nasal powder formulation for treatment of hypoglycemia
Feb, 2036

(9 years from now)

Active
US12370241 Nasal Powder Formulation For Treatment Of Hypoglycemia
Feb, 2036

(9 years from now)

Active
US6938798 Fluid or powdery product dispensing device
Jan, 2022

(4 years ago)

Expired


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 Baqsimi's patents.

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

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 05 Aug, 2025 US12370241
Patent eGrant Notification 29 Jul, 2025 US12370241
Mail Patent eGrant Notification 29 Jul, 2025 US12370241
Patent Issue Date Used in PTA Calculation 29 Jul, 2025 US12370241
Recordation of Patent eGrant 29 Jul, 2025 US12370241
Email Notification 29 Jul, 2025 US12370241
Email Notification 17 Jul, 2025 US12370241
Issue Notification Mailed 16 Jul, 2025 US12370241
Application Is Considered Ready for Issue 27 Jun, 2025 US12370241
Dispatch to FDC 27 Jun, 2025 US12370241


FDA has granted several exclusivities to Baqsimi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Baqsimi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Baqsimi.

Exclusivity Information

Baqsimi holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Baqsimi's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jul 24, 2022
New Patient Population(NPP) Mar 17, 2028

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Several oppositions have been filed on Baqsimi's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Baqsimi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Baqsimi patents.

Baqsimi's Oppositions Filed in EPO

Baqsimi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 05, 2020, by Elkington And Fife Llp. This opposition was filed on patent number EP16710352A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP16710352A Oct, 2020 ELKINGTON AND FIFE LLP Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Baqsimi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Baqsimi's family patents as well as insights into ongoing legal events on those patents.

Baqsimi's Family Patents

Baqsimi has patent protection in a total of 42 countries. It's US patent count contributes only to 11.1% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Baqsimi.

Family Patents

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Clinical Trials

Recent Clinical Trials on Baqsimi:

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.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Glucagon-like Peptide-1 Metabolism and Acute Neprilysin Inhibition University of Pennsylvania NA WITHDRAWN
(Sep 1, 2026)
PHASE3
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS Zealand Pharma NA COMPLETED
(Sep 1, 2026)
PHASE3
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes Universitaire Ziekenhuizen KU Leuven NA RECRUITING
(Sep 1, 2026)
PHASE3
Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes Victor Chang Cardiac Research Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE3
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE3
Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease The Methodist Hospital Research Institute NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE3
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity Indiana University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Semaglutide Therapy for Alcohol Reduction (STAR) National Institute on Drug Abuse (NIDA) NA ACTIVE NOT RECRUITING
(Aug 31, 2026)
PHASE2
Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes AdventHealth Translational Research Institute NA RECRUITING
(Aug 1, 2026)
PHASE2
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome University of Colorado, Denver NA RECRUITING
(Aug 1, 2026)
PHASE3
Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome Beni-Suef University NA COMPLETED
(Aug 1, 2026)
PHASE3
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial Vanderbilt University Medical Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Avexitide for Treatment of Post-Bariatric Hypoglycemia Amylyx Pharmaceuticals Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis Michael R. Rickels, MD, MS NA RECRUITING
(Aug 1, 2026)
PHASE1
Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial City of Hope Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Studies of Insulin and Glucagon Action in the Liver Duke University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer National Cancer Institute (NCI) NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus Mapi Pharma Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF) VectivBio AG NA RECRUITING
(Aug 1, 2026)
PHASE3
A Clinical Trial Evaluating TQF3250 Capsules in Patients With Type 2 Diabetes Mellitus and Overweight/Obesity Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1
Impact of GLP-1 Receptor Agonist Therapy on Alcohol Pharmacokinetics University of Wisconsin, Madison NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Clinical Trial of TQF3250 Capsules in Overweight/Obese Trial Participants With Poor Weight Control Through Simple Lifestyle Intervention Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants Hongwei Jiang NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD) National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Jul 22, 2026)
PHASE1
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism Zealand Pharma NA COMPLETED
(Jul 1, 2026)
PHASE3
Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM University of California, San Diego NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected) Novo Nordisk A/S NA RECRUITING
(Jul 1, 2026)
PHASE1
CLF065 for Chronic Pouchitis Calibr, a division of Scripps Research NA SUSPENDED
(Jul 1, 2026)
PHASE2
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes Emory University NA RECRUITING
(Jul 1, 2026)
PHASE3
Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME) West China Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial yifang zhu NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity Shahid Beheshti University of Medical Sciences NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD The Cleveland Clinic NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Lifestyle Counseling and Medication for Adolescent Weight Management University of Minnesota NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD) Chinese University of Hong Kong NA RECRUITING
(Jun 1, 2026)
PHASE2
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese Eli Lilly and Company NA COMPLETED
(Jun 1, 2026)
PHASE2
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes University of California, San Diego NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure Jens D Hove, MD,PHD NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity University of Colorado, Denver NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Semaglutide (Wegovy) Treatment for Trichotillomania University of Chicago NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events Novo Nordisk A/S NA RECRUITING
(Jun 1, 2026)
PHASE1
Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy Vanderbilt University Medical Center NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy. Fu Jen Catholic University Hospital NA RECRUITING
(Jun 1, 2026)
PHASE3
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance University of Pennsylvania NA RECRUITING
(May 1, 2026)
PHASE2
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction Adrian Vella NA RECRUITING
(May 1, 2026)
PHASE2
Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults University of Yaounde 1 NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Semaglutide for Smoking Cessation in Patients With Diabetes Ottawa Heart Institute Research Corporation NA RECRUITING
(May 1, 2026)
PHASE3
The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery The University of Texas Health Science Center at San Antonio NA RECRUITING
(May 1, 2026)
PHASE1
GLP-1 Receptor Agonist in Primary Intracerebral Hemorrhage: A Phase 2 Randomized Trial Chinese University of Hong Kong NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes. Ministry of Health, Saudi Arabia NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
The Effects of Glucagon on Hepatic Metabolism Adrian Vella NA COMPLETED
(Apr 1, 2026)
PHASE1, PHASE2
A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes Zucara Therapeutics Inc. NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH Neuraly, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE2
Tailoring Obesity Treatment Trial Esbjerg Hospital - University Hospital of Southern Denmark NA WITHDRAWN
(Apr 1, 2026)
PHASE2, PHASE3
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia University of Florida NA RECRUITING
(Apr 1, 2026)
PHASE2
The Role of Phosphodiesterase Inhibitors in Incretin Secretion National Institute on Aging (NIA) NA COMPLETED
(Mar 11, 2026)
PHASE1
To Determine Tolerability to Glucagon Infusion in Obese Subjects AdventHealth Translational Research Institute NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1
Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia Fudan University NA COMPLETED
(Mar 1, 2026)
PHASE2, PHASE3
Repurposing Semaglutide for the Treatment of Cocaine Use Disorder The University of Texas Health Science Center, Houston NA RECRUITING
(Mar 1, 2026)
PHASE2




Generic Launch

Generic Release Date:

Baqsimi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 23, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Baqsimi Generic API suppliers:

Glucagon is the generic name for the brand Baqsimi. 4 different companies have already filed for the generic of Baqsimi, with Amphastar Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Baqsimi's generic

Alternative Brands for Baqsimi

Baqsimi which is used for treating severe hypoglycemia in patients with diabetes., has several other brand drugs using the same active ingredient (Glucagon). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.


Apart from brand drugs containing the same ingredient, some generics have also been filed for Glucagon, Baqsimi's active ingredient. Check the complete list of approved generic manufacturers for Baqsimi





About Baqsimi

Baqsimi is a drug owned by Amphastar Pharmaceuticals Inc. It is used for treating severe hypoglycemia in patients with diabetes. Baqsimi uses Glucagon as an active ingredient. Baqsimi was launched by Amphastar in 2019.

Approval Date:

Baqsimi was approved by FDA for market use on 24 July, 2019.

Active Ingredient:

Baqsimi uses Glucagon as the active ingredient. Check out other Drugs and Companies using Glucagon ingredient

Treatment:

Baqsimi is used for treating severe hypoglycemia in patients with diabetes.

Dosage:

Baqsimi is available in powder form for nasal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
3MG POWDER Prescription NASAL