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, Mylan, 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 090406-001 | Feb 25, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Takeda Pharms Usa | ACTOPLUS MET XR | metformin hydrochloride; pioglitazone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024-001 | May 12, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | 022024-001 | May 12, 2009 | ⤷ 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 |
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ⤷ 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 | WO2006106815 | 錠剤 | ⤷ Sign Up |
Japan | 5881962 | ⤷ Sign Up | |
Singapore | 160415 | NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE | ⤷ 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 |
---|---|---|---|---|
1506211 | 42/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
1261586 | 1290013-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
1506211 | CR 2014 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
>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.