METRONIDAZOLE Drug Patent Profile
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When do Metronidazole patents expire, and when can generic versions of Metronidazole launch?
Metronidazole is a drug marketed by Able, Alembic, Chartwell Rx, Aurobindo Pharma Ltd, Cosette, Fougera Pharms, Zydus Lifesciences, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Sciegen Pharms, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Novitium Pharma, Pliva, Somerset Theraps Llc, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland, Hospira, Inforlife, and Rising. and is included in seventy-two NDAs.
The generic ingredient in METRONIDAZOLE is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.
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Summary for METRONIDAZOLE
| US Patents: | 0 |
| Applicants: | 44 |
| NDAs: | 72 |
| Finished Product Suppliers / Packagers: | 48 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 589 |
| Drug Prices: | Drug price information for METRONIDAZOLE |
| Drug Sales Revenues: | Drug sales revenues for METRONIDAZOLE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METRONIDAZOLE |
| What excipients (inactive ingredients) are in METRONIDAZOLE? | METRONIDAZOLE excipients list |
| DailyMed Link: | METRONIDAZOLE at DailyMed |
Recent Clinical Trials for METRONIDAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universitt Luzern | PHASE4 |
| Faiz ur rahman | NA |
| Stanford University | EARLY_PHASE1 |
Pharmacology for METRONIDAZOLE
| Drug Class | Nitroimidazole Antimicrobial |
Medical Subject Heading (MeSH) Categories for METRONIDAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for METRONIDAZOLE
Paragraph IV (Patent) Challenges for METRONIDAZOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LIKMEZ | Oral Suspension | metronidazole | 500 mg/5 mL | 216755 | 1 | 2025-11-13 |
| NUVESSA | Vaginal Gel | metronidazole | 1.30% | 205223 | 1 | 2022-03-30 |
| METROGEL | Topical Gel | metronidazole | 1% | 021789 | 1 | 2008-10-21 |
| METROGEL-VAGINAL | Vaginal Gel | metronidazole | 0.75% | 020208 | 1 | 2004-09-02 |
US Patents and Regulatory Information for METRONIDAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Strides Pharma | METRONIDAZOLE | metronidazole | TABLET;ORAL | 070040-001 | Jan 29, 1985 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Aurobindo Pharma Ltd | METRONIDAZOLE | metronidazole | TABLET;ORAL | 203974-001 | May 29, 2015 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Fougera Pharms | METRONIDAZOLE | metronidazole | LOTION;TOPICAL | 077197-001 | May 24, 2006 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Amneal | METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 217665-001 | May 24, 2023 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Flamingo Pharms | METRONIDAZOLE | metronidazole | TABLET;ORAL | 207309-001 | May 16, 2016 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
