METROGEL Drug Patent Profile
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Which patents cover Metrogel, and when can generic versions of Metrogel launch?
Metrogel is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs.
The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Metrogel
A generic version of METROGEL was approved as metronidazole by TEVA PHARMS USA on November 6th, 1984.
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Summary for METROGEL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 172 |
| Clinical Trials: | 14 |
| Patent Applications: | 1,882 |
| Drug Prices: | Drug price information for METROGEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METROGEL |
| What excipients (inactive ingredients) are in METROGEL? | METROGEL excipients list |
| DailyMed Link: | METROGEL at DailyMed |
Recent Clinical Trials for METROGEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| New York Medical College | Phase 4 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| Alfasigma S.p.A. | Phase 2 |
Pharmacology for METROGEL
| Drug Class | Nitroimidazole Antimicrobial |
Paragraph IV (Patent) Challenges for METROGEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| METROGEL | Topical Gel | metronidazole | 1% | 021789 | 1 | 2008-10-21 |
US Patents and Regulatory Information for METROGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for METROGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for METROGEL
See the table below for patents covering METROGEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2062366 | ⤷ Sign Up | |
| European Patent Office | 1467744 | COMPOSITIONS AQUEUSES CONTENANT DU METRONIDAZOLE (AQUEOUS COMPOSITIONS CONTAINING METRONIDAZOLE) | ⤷ Sign Up |
| Australia | 621589 | ⤷ Sign Up | |
| European Patent Office | 0404376 | Compositions tamponnéesde mêtronidazole pour traitement intravaginal d infections vaginales. (Buffered metronidazole compositions for intravaginal treatment of vaginal infections.) | ⤷ Sign Up |
| China | 100411624 | ⤷ Sign Up | |
| Australia | 3043289 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for METROGEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0328535 | 96C0021 | Belgium | ⤷ Sign Up | PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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