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, Celltrion, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Picket Pharms, Prinston Inc, Puracap Pharm Llc, Sandoz, Shuangcheng, 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-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for pioglitazone hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 16 |
NDAs: | 16 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 26 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 480 |
Patent Applications: | 4,388 |
Formulation / Manufacturing: | see details |
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 |
---|---|
EMS | Phase 3 |
Cairo University | Phase 4 |
St. Louis University | Phase 2 |
Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 45MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 30MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 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
Drug Class | Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione |
Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Anatomical Therapeutic Chemical (ATC) Classes for pioglitazone hydrochloride
US Patents and Regulatory Information for pioglitazone hydrochloride
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 | 021073-002 | Jul 15, 1999 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-002 | Jul 15, 1999 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-002 | Jul 15, 1999 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-001 | Jul 15, 1999 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-001 | Jul 15, 1999 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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