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Pioglitazone hydrochloride - Generic Drug Details

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Pioglitazone hydrochloride is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Teva Pharms Usa, Lupin Ltd, Accord Hlthcare, Zydus Pharms Usa Inc, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Sandoz, Breckenridge Pharm, Takeda Pharms Usa, Dr Reddys Labs Ltd, Torrent Pharms Ltd, and Watson Labs, and is included in thirteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-one patent family members in twenty-five countries.

There are twenty-seven drug master file entries for pioglitazone hydrochloride. Thirty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: pioglitazone hydrochloride

Tradenames:2
Patents:10
Applicants:13
NDAs:13
Drug Master File Entries: see list27
Suppliers / Packaging: see list32
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL15MG
<disabled><disabled>TABLET; ORAL30MG
<disabled><disabled>TABLET; ORAL45MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL200268-002Feb 13, 2013RXNo► subscribe► subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 1999RXNo6,271,243► subscribe ► subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 1999RXNo6,150,384► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-001Jul 15, 19996,172,090► subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 19996,329,404► subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-002Jul 15, 19994,687,777► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
6,080,765 Pharmaceutical composition► subscribe
6,169,099 Pharmaceutical composition► subscribe
6,121,294 Pharmaceutical composition► 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: pioglitazone hydrochloride

Country Document Number Estimated Expiration
Cyprus2424► subscribe
Russian Federation2223760► subscribe
European Patent Office0861666► 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: PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
298Luxembourg► subscribe91298, EXPIRES: 20210620
2009 00045Denmark► subscribe
1174135/01Switzerland► subscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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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 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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