METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of patent protection?
Metformin hydrochloride; pioglitazone hydrochloride
is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Norvium Bioscience, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Metformin hydrochloride; pioglitazone hydrochloride has one hundred and thirteen patent family members in thirty-two countries.
Five suppliers are listed for this compound.
Summary for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
International Patents: | 113 |
US Patents: | 4 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 5 |
Clinical Trials: | 155 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
DailyMed Link: | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Phase 2 |
Nanjing First Hospital, Nanjing Medical University | Phase 3 |
Affiliated Hospital of Nantong University | Phase 1 |
See all METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials
Pharmacology for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACTOPLUS MET XR | Extended-release Tablets | metformin hydrochloride; pioglitazone hydrochloride | 15 mg/1000 mg and 30 mg/1000 mg | 022024 | 1 | 2011-09-23 |
US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Expired US Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-002 | May 12, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5022893 | ⤷ Sign Up | |
Portugal | 1867324 | ⤷ Sign Up | |
Costa Rica | 7797 | PREPARACION SOLIDA | ⤷ Sign Up |
Japan | 2004149521 | SOLID PHARMACEUTICAL PREPARATION | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | PA2012022 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
2498758 | CA 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 |
2498758 | PA2020003 | Lithuania | ⤷ Sign Up | PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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