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Healthtrust
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Cipla
Fuji
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Generated: August 23, 2017

DrugPatentWatch Database Preview

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 metformin hydrochloride; pioglitazone hydrochloride patent protection?

Metformin hydrochloride; pioglitazone hydrochloride
is the generic ingredient in three branded drugs marketed by Torrent Pharms Ltd, Macleods Pharms Ltd, Mylan, Aurobindo Pharma Ltd, Takeda Pharms Usa, Teva Pharms Usa, and Sandoz, and is included in eight NDAs. There are thirteen 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 thirty-nine patent family members in thirty-two countries.

There are forty-eight drug master file entries for metformin hydrochloride; pioglitazone hydrochloride. Thirteen suppliers are listed for this compound.

Summary for Generic Name: metformin hydrochloride; pioglitazone hydrochloride

Tradenames:3
Patents:13
Applicants:7
NDAs:8
Drug Master File Entries: see list48
Suppliers / Packagers: see list13
Clinical Trials: see list4,202
Drug Prices:see low prices
DailyMed Link:metformin hydrochloride; pioglitazone hydrochloride at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: metformin hydrochloride; pioglitazone hydrochloride

Non-Orange Book Patents for Generic Ingredient: metformin hydrochloride; pioglitazone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,084,058Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative► Subscribe
8,309,125Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: metformin hydrochloride; pioglitazone hydrochloride

Country Document Number Estimated Expiration
Japan4236553► Subscribe
World Intellectual Property Organization (WIPO)2005107750► Subscribe
Morocco27487► Subscribe
Hong Kong1136780► Subscribe
Brazil0115390► 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 Certificates for Tradename: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
/2012Austria► SubscribePRODUCT 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
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
496Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Farmers Insurance
Covington
Express Scripts
Federal Trade Commission
Cantor Fitzgerald
Mallinckrodt
Argus Health
Baxter

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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