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Generated: June 28, 2017
Which patents cover Metrogel, and what generic Metrogel alternatives are available?
Metrogel is a drug marketed by Galderma Labs Lp and Medicis and is included in three NDAs. There are two patents protecting this drug and two Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 3 |
| Suppliers / Packagers: see list | 5 |
| Bulk Api Vendors: see list | 110 |
| Clinical Trials: see list | 13 |
| Patent Applications: see list | 9,472 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | METROGEL at DailyMed |
| Ingredient-type | Nitroimidazoles |
| Drug Class | Nitroimidazole Antimicrobial |
| 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 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | 7,348,317 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | 6,881,726 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | 4,837,378 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| metronidazole | Topical Gel | 1% | Metrogel | 10/21/2008 |
| metronidazole | Vaginal Gel | 0.75% | MetroGel-Vaginal | 9/2/2004 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100718858 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA04006210 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2352656 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2238980 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2002340458 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0021 | Belgium | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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