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 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-one countries.
Three suppliers are listed for this compound.
Summary for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
International Patents: | 59 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 20 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
DailyMed Link: | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Seoul National University Hospital | Phase 4 |
Kanazawa University | Phase 4 |
Kowa Company, Ltd. | Phase 4 |
See all GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials
Pharmacology 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 | 021925-002 | Jul 28, 2006 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Sandoz | PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 201049-001 | Jan 4, 2013 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
>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 | 021925-002 | Jul 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Croatia | P20151447 | ⤷ Subscribe | |
Ukraine | 91729 | ТВЕРДАЯ ФОРМА ЛЕКАРСТВЕННОГО ПРЕПАРАТА;ТВЕРДА ФОРМА ЛІКАРСЬКОГО ПРЕПАРАТУ (SOLID PREPARATION) | ⤷ Subscribe |
Georgia, Republic of | P20084570 | SOLID PREPARATION COMPRISING AN INSULIN SENSITIZER, AN INSULIN SECRETAGOGUE AND A POLYOXYETHYLENE SORBITAN FATTY ACID ESTER | ⤷ Subscribe |
Brazil | PI0414979 | preparação sólida | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental
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