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, Cosette, Fougera Pharms, Zydus Lifesciences, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, and Rising. and is included in sixty-eight 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: | 42 |
| NDAs: | 68 |
| Finished Product Suppliers / Packagers: | 54 |
| Raw Ingredient (Bulk) Api Vendors: | 172 |
| Clinical Trials: | 526 |
| Patent Applications: | 3,997 |
| 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 |
See drug prices for METRONIDAZOLE
Recent Clinical Trials for METRONIDAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Universitario Evangelico de Curitiba | Phase 3 |
| National Dental PBRN | Phase 3 |
| Rutgers, The State University of New Jersey | Phase 3 |
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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unichem | METRONIDAZOLE | metronidazole | TABLET;ORAL | 203458-001 | Jan 22, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cadila Pharms Ltd | METRONIDAZOLE | metronidazole | TABLET;ORAL | 209794-001 | Dec 12, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Able | METRONIDAZOLE | metronidazole | TABLET;ORAL | 076519-002 | Jun 27, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
