Metronidazole Patent Expiration

Metronidazole was first introduced by Pfizer Inc in its drug Flagyl on Approved Prior to Jan 1, 1982. Other drugs containing Metronidazole are Vandazole, Protostat, Nuvessa, Metrogel, Metronidazole, Noritate, Metronidazole In Plastic Container, Metrolotion, Metrogel-Vaginal, Metrocream, Metro I.V., Flagyl I.V. Rtu In Plastic Container, Flagyl Er, Likmez, Metro I.V. In Plastic Container. 55 different companies have introduced drugs containing Metronidazole.


Metronidazole Patents

Given below is the list of patents protecting Metronidazole, 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
Likmez US11541035 Oral formulations of metronidazole and methods of treating an infection using same Oct 04, 2039 Saptalis Pharms
Likmez US12257236 Oral formulations of metronidazole and methods of treating an infection using same Jan 16, 2039 Saptalis Pharms
Nuvessa US10238634 Aqueous-based metronidazole gel formulations Jun 28, 2032 Alembic Therap
Nuvessa US10596155 Aqueous-based metronidazole gel formulations Jun 28, 2032 Alembic Therap
Nuvessa US8946276 High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis Jun 28, 2032 Alembic Therap
Nuvessa US9198858 Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations Jun 28, 2032 Alembic Therap
Nuvessa US8658678 Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water Jun 27, 2028 Alembic Therap
Nuvessa US7893097 Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water Feb 19, 2028 Alembic Therap
Nuvessa US8877792 Compositions for increasing solubility of azole drug compounds that are poorly soluble in water Feb 02, 2028 Alembic Therap
Vandazole US7456207 Vaginal pharmaceutical compositions and methods for preparing them Sep 22, 2024

(Expired)

Teva Pharms
Metrogel US6881726 Aqueous compositions containing metronidazole Feb 21, 2022

(Expired)

Galderma Labs Lp
Metrogel US7348317 Aqueous compositions containing metronidazole Feb 21, 2022

(Expired)

Galderma Labs Lp
Flagyl Er US6103262 Modified-release metronidazole compositions and methods for making and using same Aug 15, 2017

(Expired)

Pfizer
Metrogel-vaginal US5536743 Intravaginal treatment of vaginal infections with buffered metronidazole compositions Jul 16, 2013

(Expired)

Bausch



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 Metronidazole's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 23 Dec, 2016 US7456207
Patent Issue Date Used in PTA Calculation 25 Nov, 2008 US7456207
Recordation of Patent Grant Mailed 25 Nov, 2008 US7456207
Issue Notification Mailed 05 Nov, 2008 US7456207
Dispatch to FDC 24 Oct, 2008 US7456207
Application Is Considered Ready for Issue 17 Oct, 2008 US7456207
Issue Fee Payment Verified 09 Oct, 2008 US7456207
Issue Fee Payment Received 09 Oct, 2008 US7456207
Mail Examiner's Amendment 22 Sep, 2008 US7456207
Mail Notice of Allowance 22 Sep, 2008 US7456207


About Veterinary Metronidazole

Metronidazole is used in a drug marketed by 1 company: Virbac Ah Inc.

Other drugs containing Metronidazole are: Ayradia .

Veterinary Metronidazole Patents

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

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Drug Used In Drug Patent Number Drug Patent Expiry Drug Owner
Patent Data
AYRADIA US10426840 VIRBAC AH, INC.

Metronidazole's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Metronidazole:

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
Vaginal Microbiota Transplant Douglas Kwon NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative) Johns Hopkins University NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess Post Graduate Institute of Medical Education and Research, Chandigarh NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer Case Comprehensive Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Precision Antibiotic Dosing for Appendectomy University of Michigan NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial Freya Biosciences ApS NA RECRUITING
(Aug 1, 2026)
PHASE2
Nitazoxanide vs Metronidazole for Entamoeba Diarrhea in Children University of Child Health Sciences and Children's Hospital, Lahore NA COMPLETED
(Aug 1, 2026)
PHASE2
Piperacillin/Tazobactam Versus ceftriAxone and Metronidazole for Children With Perforated Appendicitis (ALPACA) McMaster Children's Hospital NA COMPLETED
(Jul 1, 2026)
PHASE2
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ? University Hospital, Rouen NA COMPLETED
(Apr 1, 2026)
PHASE3
Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy M.D. Anderson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE2
MOTIF@FRESH: Modifying Organisms Transvaginally in Females @ FRESH Douglas Kwon NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients Chengdu Syncor Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Metronidazole Generic API Manufacturers

Several generic applications have been filed for Metronidazole. The first generic version for Metronidazole was by Teva Pharmaceuticals Usa Inc and was approved on Nov 6, 1984. And the latest generic version is by Zydus Lifesciences Ltd and was approved on Feb 13, 2026.

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