Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

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 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.

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

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

Recent Clinical Trials for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

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SponsorPhase
TakedaPhase 4
Azienda Ospedaliera di PadovaPhase 4
University of PadovaPhase 4

See all GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials

Recent Litigation for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

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District Court Litigation
Case NameDate
Takeda Pharmaceutical Company Limited v. Hetero Drugs Limited2011-11-16
Takeda Pharmaceutical Company Limited v. Accord Healthcare, Inc.2011-09-12
Takeda Pharmaceutical Company Limited v. Macleods Pharmaceuticals Limited2011-05-06

See all GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE litigation

Paragraph IV (Patent) Challenges for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
DUETACT TABLET;ORAL glimepiride; pioglitazone hydrochloride 021925 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   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-002 Jul 28, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa DUETACT glimepiride; pioglitazone hydrochloride TABLET;ORAL 021925-001 Jul 28, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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

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

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Serving leading biopharmaceutical companies globally:

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