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Pioglitazone hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pioglitazone hydrochloride?

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 is one patent 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-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: pioglitazone hydrochloride

Tradenames:2
Patents:2
Applicants:13
NDAs:13
Drug Master File Entries: see list27
Suppliers / Packagers: see list34
Bulk Api Vendors: see list82
Clinical Trials: see list1,112
Patent Applications: see list1,964
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pioglitazone hydrochloride at DailyMed

Tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL15MG
► Subscribe► SubscribeTABLET; ORAL30MG
► Subscribe► SubscribeTABLET; ORAL45MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL200268-001Feb 13, 2013RXNoNo► Subscribe► Subscribe
Watson Labs
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076798-001Oct 26, 2012RXNoNo► Subscribe► Subscribe
Macleods Pharms Ltd
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL202467-003Feb 6, 2013RXNoNo► Subscribe► Subscribe
Watson Labs
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL076798-003Oct 26, 2012RXNoNo► Subscribe► Subscribe
Teva Pharms Usa
PIOGLITAZONE HYDROCHLORIDE
pioglitazone hydrochloride
TABLET;ORAL077210-001Jan 10, 2014RXNoNo► 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;ORAL021073-003Jul 15, 19996,271,243► Subscribe
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;ORAL021073-003Jul 15, 19996,329,404► Subscribe
Takeda Pharms Usa
ACTOS
pioglitazone hydrochloride
TABLET;ORAL021073-003Jul 15, 19996,150,383► 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
6,121,295 Pharmaceutical composition► Subscribe
6,323,225 Pharmaceutical composition► Subscribe
6,172,089 Pharmaceutical composition► Subscribe
6,103,742 Pharmaceutical composition► Subscribe
6,166,042 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
South Africa9605190► Subscribe
China1530106► Subscribe
Luxembourg91298► Subscribe
Norway317341► Subscribe
Taiwan438587► 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
C0006France► SubscribePRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
C026/2009Ireland► SubscribeSPC026/2009: 20101001, EXPIRES: 20210619
298Luxembourg► Subscribe91298, EXPIRES: 20210620
01C/011Belgium► SubscribePRODUCT NUMBER: PIOGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/001/150/001 20001018; FIRST REGISTRATION NO: CH 55378 01 20000927
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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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