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Last Updated: November 4, 2024

Glimepiride; pioglitazone hydrochloride - Generic Drug Details


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What are the generic sources for glimepiride; pioglitazone hydrochloride and what is the scope of freedom to operate?

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.

Glimepiride; pioglitazone hydrochloride has fifty-nine patent family members in thirty-one countries.

Three suppliers are listed for this compound.

Summary for glimepiride; pioglitazone hydrochloride
Recent Clinical Trials for glimepiride; pioglitazone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Seoul National University HospitalPhase 4
Kanazawa UniversityPhase 4
Kowa Company, Ltd.Phase 4

See all glimepiride; pioglitazone hydrochloride clinical trials

Paragraph IV (Patent) Challenges for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DUETACT Tablets glimepiride; pioglitazone hydrochloride 30 mg/2 mg and 30 mg/4 mg 021925 1 2009-12-22

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
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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
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
>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 glimepiride; pioglitazone hydrochloride

International Patents for glimepiride; pioglitazone hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2005041962 ⤷  Sign Up
Norway 20083104 ⤷  Sign Up
European Patent Office 1962811 PRÉPARATION SOLIDE CONTENANT UN SENSIBILISATEUR Ă€ L'INSULINE (SOLID PREPARATION CONTAINING AN INSULIN SENSITIZER) ⤷  Sign Up
Morocco 28116 PREPARATION SOLIDE COMPRENANT UN SENSIBILISATEUR A L'INSULINE, UN SECRETAGOGUE D'INSULINE ET UN ESTER D'ACIDE GRAS DE POLYOXYETHYLENE SORBITAN ⤷  Sign Up
Taiwan 200731971 Solid preparation ⤷  Sign Up
Spain 2556244 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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