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-six 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.
Summary for FORTAMET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 41 |
Patent Applications: | 680 |
Formulation / Manufacturing: | see details |
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 |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
University of Colorado, Denver | Phase 1 |
St. Jude Children's Research Hospital | Phase 2 |
Pharmacology for FORTAMET
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for FORTAMET
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Andrx Labs Llc | FORTAMET | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021574-001 | Apr 27, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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
International Patents for FORTAMET
See the table below for patents covering FORTAMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2564750 | ⤷ Try a Trial | |
Japan | 2004531463 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9947125 | ⤷ Try a Trial | |
European Patent Office | 1063971 | COMPRIMES ORAUX A NOYAU MONOLITHIQUE A LIBERATION CONTROLEE (CONTROLLED RELEASE ORAL TABLET HAVING A UNITARY CORE) | ⤷ Try a Trial |
China | 1308520 | ⤷ Try a Trial | |
Canada | 2427195 | COMPOSITIONS DE METFORMINE A LIBERATION CONTROLEE (CONTROLLED RELEASE METFORMIN COMPOSITIONS) | ⤷ Try a Trial |
European Patent Office | 1723948 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORTAMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498758 | 16/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113 |
1261586 | 15/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 |
1261586 | 1290013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
1412357 | DO 77; 5006-2008 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
1412357 | SPC/GB08/040 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716 |
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1412357 | PA2008013,C1412357 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |