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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, Aurobindo Pharma Ltd, Breckenridge, Celltrion, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Neopharma, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-seven drug master file entries for pioglitazone hydrochloride. Twenty-four 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: | 15 |
| Drug Master File Entries: | 27 |
| Suppliers / Packagers: | 24 |
| Bulk Api Vendors: | 121 |
| Clinical Trials: | 429 |
| Patent Applications: | 3,876 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pioglitazone hydrochloride |
| DailyMed Link: | pioglitazone hydrochloride at DailyMed |
Recent Clinical Trials for pioglitazone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Azienda Ospedaliero-Universitaria di Parma | Phase 2/Phase 3 |
| Milton S. Hershey Medical Center | Phase 1/Phase 2 |
| National Center for Advancing Translational Science (NCATS) | Phase 1/Phase 2 |
Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 45MG | TABLET; ORAL |
| Start Trial | Start Trial | 30MG | TABLET; ORAL |
| Start Trial | Start Trial | 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 | Thiazolidinedione Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist |
| Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Paragraph IV (Patent) Challenges for PIOGLITAZONE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ACTOS | TABLET;ORAL | pioglitazone hydrochloride | 021073 |
US Patents and Regulatory Information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 077210-002 | Jan 10, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin Ltd | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 204133-001 | Apr 7, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Puracap Pharm Llc | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 206738-003 | Oct 6, 2017 | AB | RX | No | No | Start Trial | Start Trial | 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 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 | Start Trial | Start Trial |
| Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-001 | Jul 15, 1999 | Start Trial | Start Trial |
| Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-003 | Jul 15, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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