FORTAMET Drug Patent Profile
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Which patents cover Fortamet, and when can generic versions of Fortamet launch?
Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA.
The generic ingredient in FORTAMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fortamet
A generic version of FORTAMET was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
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Questions you can ask:
- What is the 5 year forecast for FORTAMET?
- What are the global sales for FORTAMET?
- What is Average Wholesale Price for FORTAMET?
Summary for FORTAMET
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 43 |
| Patent Applications: | 579 |
| Drug Prices: | Drug price information for FORTAMET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FORTAMET |
| What excipients (inactive ingredients) are in FORTAMET? | FORTAMET excipients list |
| DailyMed Link: | FORTAMET at DailyMed |
Recent Clinical Trials for FORTAMET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brigham and Women's Hospital | Phase 2 |
| Arthritis Foundation | Phase 2 |
| University of Colorado, Denver | Phase 1 |
Paragraph IV (Patent) Challenges for FORTAMET
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FORTAMET | Extended-release Tablets | metformin hydrochloride | 500 mg and 1000 mg | 021574 | 1 | 2008-10-14 |
US Patents and Regulatory Information for FORTAMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | AB2 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | DISCN | Yes | 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 |
Expired US Patents for FORTAMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-002 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FORTAMET
See the table below for patents covering FORTAMET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4557424 | ⤷ Sign Up | |
| Mexico | PA03003994 | COMPOSICIONES DE METFORMINA DE LIBERACION CONTROLADA. (CONTROLLED RELEASE METFORMIN COMPOSITIONS.) | ⤷ Sign Up |
| China | 1158999 | ⤷ Sign Up | |
| Australia | 3101999 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0236100 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORTAMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1532149 | C300569 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720 |
| 2498758 | 132020000000034 | Italy | ⤷ Sign Up | PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113 |
| 2498758 | CR 2020 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
| 1506211 | SPC/GB14/050 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121 |
| 1261586 | 2012C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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