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Generated: September 23, 2018

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Glimepiride; pioglitazone hydrochloride - Generic Drug Details

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What are the generic drug sources for glimepiride; pioglitazone hydrochloride and what is the scope of glimepiride; pioglitazone hydrochloride patent protection?

Glimepiride; pioglitazone hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Sandoz, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for glimepiride; pioglitazone hydrochloride. Three suppliers are listed for this compound.

US Patents and Regulatory Information for glimepiride; pioglitazone hydrochloride

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 DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sandoz PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE glimepiride; pioglitazone hydrochloride TABLET;ORAL 201049-001 Jan 4, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE glimepiride; pioglitazone hydrochloride TABLET;ORAL 201049-002 Jan 4, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 AB RX Yes Yes ➤ 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

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Expired US Patents for glimepiride; pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
Dow
US Army
Merck
Farmers Insurance
Deloitte
Cerilliant
Chinese Patent Office

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