Pioglitazone hydrochloride - Generic Drug Details
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What are the generic drug sources for pioglitazone hydrochloride and what is the scope of freedom to operate?
Pioglitazone hydrochloride
is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Accord Hlthcare, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-seven drug master file entries for pioglitazone hydrochloride. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for pioglitazone hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 15 |
NDAs: | 16 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 27 |
Raw Ingredient (Bulk) Api Vendors: | 138 |
Clinical Trials: | 500 |
Patent Applications: | 4,464 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pioglitazone hydrochloride |
What excipients (inactive ingredients) are in pioglitazone hydrochloride? | pioglitazone hydrochloride excipients list |
DailyMed Link: | pioglitazone hydrochloride at DailyMed |
Recent Clinical Trials for pioglitazone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Phase 2 |
Wuhan Union Hospital, China | Phase 2 |
University of Campinas, Brazil | Phase 4 |
Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 45MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 30MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 15MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for pioglitazone hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 078383-001 | Mar 12, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chartwell Rx | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 078383-002 | Mar 12, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Prinston Inc | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 207806-003 | Apr 17, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 078670-001 | Feb 13, 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 pioglitazone hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-003 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-001 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-003 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-003 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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