METROGEL Drug Patent Profile
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Which patents cover Metrogel, and what generic alternatives are available?
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-two 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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Questions you can ask:
- What is the 5 year forecast for METROGEL?
- What are the global sales for METROGEL?
- What is Average Wholesale Price for METROGEL?
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 |
Alfa Wassermann 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 |
---|---|---|---|
Russian Federation | 2006116252 | ⤷ Sign Up | |
Germany | 68914365 | ⤷ Sign Up | |
Germany | 69007547 | ⤷ Sign Up | |
Japan | 2714464 | ⤷ Sign Up | |
South Korea | 0135313 | ⤷ Sign Up | |
Poland | 164128 | ⤷ 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 |