METROGEL-VAGINAL Drug Patent Profile
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Which patents cover Metrogel-vaginal, and when can generic versions of Metrogel-vaginal launch?
Metrogel-vaginal is a drug marketed by Bausch and is included in one NDA.
The generic ingredient in METROGEL-VAGINAL 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-vaginal
A generic version of METROGEL-VAGINAL was approved as metronidazole by TEVA PHARMS USA on November 6th, 1984.
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Summary for METROGEL-VAGINAL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 172 |
| Clinical Trials: | 5 |
| Patent Applications: | 1,573 |
| DailyMed Link: | METROGEL-VAGINAL at DailyMed |
Recent Clinical Trials for METROGEL-VAGINAL
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| Sponsor | Phase |
|---|---|
| New York Medical College | Phase 4 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| Alfasigma S.p.A. | Phase 2 |
Paragraph IV (Patent) Challenges for METROGEL-VAGINAL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| METROGEL-VAGINAL | Vaginal Gel | metronidazole | 0.75% | 020208 | 1 | 2004-09-02 |
US Patents and Regulatory Information for METROGEL-VAGINAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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-VAGINAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for METROGEL-VAGINAL
See the table below for patents covering METROGEL-VAGINAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1032900 | ⤷ Sign Up | |
| Russian Federation | 2032402 | COMPOSITION AND METHOD FOR TREATING VAGINITIS | ⤷ Sign Up |
| Romania | 109156 | COMPOZITIE CU METRONIDAZOL,PENTRU INFECTIILE VAGINALE SI METODA DE TRATAMENT CU ACEASTA (COMPOSITION WITH METRONIDAZOLE FOR VAGINAL INFECTIONS AND TREATMENT METHOD THEREOF) | ⤷ Sign Up |
| Canada | 1337279 | TRAITEMENT INTRAVAGINAL D'INFECTIONS VAGINALES AU MOYEN DE COMPOSITIONS A BASE DE METRONIDAZOLE TAMPONNE (INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE COMPOSITIONS) | ⤷ Sign Up |
| South Africa | 8900233 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 8906537 | ⤷ Sign Up | |
| Australia | 635752 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for METROGEL-VAGINAL
| 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.
ISSN: 2162-2639
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