Amoxicillin Patent Expiration

Amoxicillin is Used for treating tonsillitis and/or pharyngitis caused by Streptococcus pyogenes with once-a-day amoxicillin product. It was first introduced by Glaxosmithkline in its drug Amoxil on Approved Prior to Jan 1, 1982. Other drugs containing Amoxicillin are Moxatag, Larotid. 21 different companies have introduced drugs containing Amoxicillin.


Amoxicillin Patents

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

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Moxatag US8299052 Pharmaceutical compositions and methods for improved bacterial eradication May 07, 2027 Pragma
Moxatag US8357394 Compositions and methods for improved efficacy of penicillin-type antibiotics Dec 08, 2026 Pragma
Moxatag US8778924 Modified release amoxicillin products Dec 08, 2026 Pragma
Moxatag US6544555 Antibiotic product, use and formulation thereof Oct 13, 2020

(Expired)

Pragma
Moxatag US6669948 Antibiotic product, use and formulation thereof Oct 13, 2020

(Expired)

Pragma
Moxatag US6723341 Antibiotic product, use and formulation thereof Oct 13, 2020

(Expired)

Pragma



About Veterinary Amoxicillin

Amoxicillin has petitions filed by 3 different petitioners: Schafer Veterinary Consultants Llc , VéToquinol Na Inc , Smart Drug Systems Inc .

Amoxicillin Petitions

Details of Amoxicillin's suitability petitions are listed below.

Petitioner Action Date of Action Description
Suitability Petitions
Schafer Veterinary Consultants, LLC Approved
Smart Drug Systems, Inc. Filed 20 Jan, 2004 The generic product will have a different strength from the pioneer.
Vétoquinol N.-A., Inc. Approved

Amoxicillin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Amoxicillin:

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
Efficacy and Safety of Black Seed Oil With Vonoprazan Based Triple Therapy in Treatment of Helicobacter Pylori Ain Shams University NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial Bart Koes NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) Vanderbilt University Medical Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Bismuth Quadruple Therapy Versus Modified Bismuth Therapy for Helicobacter Pylori Reham Abdelkader Elkhouly NA COMPLETED
(Sep 1, 2026)
PHASE3
Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer Sixth Affiliated Hospital, Sun Yat-sen University NA RECRUITING
(Aug 1, 2026)
PHASE2
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection University College, London NA RECRUITING
(Aug 1, 2026)
PHASE2
Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children University of Virginia NA RECRUITING
(Aug 1, 2026)
PHASE2
Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers Indonesia University NA RECRUITING
(Aug 1, 2026)
PHASE2
Enhancing Amoxicillin Pharmacokinetics and Pharmacodynamics Parameters With Probenecid in Bone and Joint Infections Assistance Publique - Hôpitaux de Paris NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis Takeda NA RECRUITING
(Jul 1, 2026)
PHASE3
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination Basilea Pharmaceutica NA RECRUITING
(Jul 1, 2026)
PHASE1
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans VA Office of Research and Development NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG - Second Trial Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Gut Microbiota Modulation for Immunotherapy Resensitization in Advanced Renal Cell Carcinoma Jinling Hospital, China NA RECRUITING
(Jul 1, 2026)
PHASE2
Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections Centre Hospitalier Universitaire de Nice NA RECRUITING
(Jun 1, 2026)
PHASE3
Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation IRCCS Azienda Ospedaliero-Universitaria di Bologna NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study) National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(May 1, 2026)
PHASE1
Oral Amoxicillin and Cephalexin PK/PD in Neonates University of Colorado, Denver NA COMPLETED
(May 1, 2026)
PHASE1
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis London School of Hygiene and Tropical Medicine NA RECRUITING
(May 1, 2026)
PHASE2
Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children University Hospital, Toulouse NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori Xuanzhu Biopharmaceutical Co., Ltd. NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice Rutgers, The State University of New Jersey NA COMPLETED
(Apr 1, 2026)
PHASE3
Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward Nantes University Hospital NA RECRUITING
(Apr 1, 2026)
PHASE3
The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department The Hospital for Sick Children NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication National Taiwan University Hospital NA RECRUITING
(Apr 1, 2026)
PHASE3
Finnish Children´s Protracted Cough Tampere University Hospital NA RECRUITING
(Apr 1, 2026)
PHASE3
Different Amoxicillin Treatment Regimens in Erythema Migrans Patients University Medical Centre Ljubljana NA RECRUITING
(Mar 1, 2026)
PHASE3
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN M.D. Anderson Cancer Center NA COMPLETED
(Mar 1, 2026)
PHASE2
Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study Nanjing First Hospital, Nanjing Medical University NA COMPLETED
(Mar 1, 2026)
Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients. Versailles Hospital NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial The University of Queensland NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Amoxicillin Generic API Manufacturers

Several generic applications have been filed for Amoxicillin. The first generic version for Amoxicillin was by Apothecon Inc Div Bristol Myers Squibb and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Micro Labs Ltd and was approved on Jun 24, 2022.

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


Amoxicillin News

Haryana Company Caught Distributing Fake Medications to Ladakh Under Himachal Pharma Branding

15 Nov, 2025

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