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Pioglitazone hydrochloride - Generic Drug Details
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What are the generic 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-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: | 15 |
| Drug Master File Entries: | 27 |
| Suppliers / Packagers: | 27 |
| Bulk Api Vendors: | 119 |
| Clinical Trials: | 425 |
| Patent Applications: | 3,808 |
| 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 |
|---|---|
| National Center for Advancing Translational Science (NCATS) | Phase 1/Phase 2 |
| Milton S. Hershey Medical Center | Phase 1/Phase 2 |
| Khyber Medical University Peshawar | Phase 4 |
Recent Litigation for pioglitazone hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Takeda Pharmaceutical Company Limited v. Mylan, Inc. | 2012-01-03 |
| Takeda Pharmaceutical Company Limited v. Hetero Drugs Limited | 2011-11-16 |
| Takeda Pharmaceutical Company Limited v. Accord Healthcare, Inc. | 2011-09-12 |
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 |
Synonyms for pioglitazone hydrochloride
| (+-)-5-(p-(2-(5-Ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione monohydrochloride |
| [(+-)-5-[[4-[4-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] monohydrochloride |
| [5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione hydrochloride |
| 025P468 |
| 112529-15-4 |
| 127676-30-6 |
| 2,4-Thiazolidinedione, 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-, monohydrochloride, (+-)- |
| 2,4-Thiazolidinedione, 5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-, monohydrochloride |
| 2,4-thiazolidinedione,5-((4-(2-(5-ehtyl-2-pyridinyl)ethoxy)phenyl)methyl)-monohydrochloride |
| 5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-2,4-thiazolidinedione, hcl |
| 5-({4-[2-(5-ethylpyridin-2-yl)ethoxy]phenyl}methyl)-1,3-thiazolidine-2,4-dione hydrochloride |
| 5-(4-(2-(5-Ethylpyridin-2-yl)ethoxy)benzyl)thiazolidine-2,4-dione hydrochloride |
| 5-(4-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl)thiazolidine-2,4-dione hydrochloride |
| 5-(4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl)-thiazolidine-2,4-dione hcl |
| 5-(4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl)-thiazolidine-2,4-dione hydrochloride |
| 5-[[4-[2-(5-Ethyl-2-pyridinyl)-ethoxy]phenyl]methyl]-2,4-thiazolidinedione hydrochloride |
| 5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione monohydrochloride |
| 5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, hydrochloride |
| 5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]thiazolidine-2,4-dione hydrochloride |
| 5-[[4-[2-(5-ethyl-2-pyridyl)ethoxy]phenyl]methyl]thiazolidine-2,4-dione hydrochloride |
| 5-[[4-[2-(5-ethylpyridin-2-yl)ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione hydrochloride |
| 5-[[4-[2-(5-ethylpyridin-2-yl)ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione;hydrochloride |
| 5-[4-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl]-2,4-thiazolidinedione Hydrochloride |
| 5-[4-[2-(5-ethyl-2-pyridyl)ethoxy]benzyl]thiazolidine-2,4-dione hydrochloride |
| 5-[4-[2-(5-ethyl-pyridin-2-yl)-ethoxy]-benzyl]-thiazolidine-2,4-dione hydrochloride |
| 5-{4-[2-(5-Ethyl-pyridin-2-yl)-ethoxy]-benzyl}-thiazolidine-2,4-dione HCl |
| 5-{4-[2-(5-Ethyl-pyridin-2-yl)-ethoxy]-benzyl}-thiazolidine-2,4-dione hydrochloride |
| 5-{4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione hydrochloride |
| A-2403 |
| A802593 |
| AA-10090 |
| AB0013914 |
| AB1009260 |
| AC-1037 |
| AC1L1THE |
| AC1Q6GK5 |
| ACT04238 |
| Actos (TN) |
| AD 4833 |
| AK-50391 |
| AKOS015844016 |
| AM20061770 |
| AN-15335 |
| ANW-42027 |
| BC204340 |
| BCP0726000151 |
| BCP22942 |
| BR-50391 |
| C19H20N2O3S.HCl |
| C19H21ClN2O3S |
| CAS-112529-15-4 |
| CCG-100931 |
| CCG-39097 |
| CHEBI:8229 |
| CHEMBL1715 |
| CP0139 |
| CPD000469167 |
| CS-2235 |
| CTK8B3228 |
| D00945 |
| DSSTox_CID_24203 |
| DSSTox_GSID_44203 |
| DSSTox_RID_80116 |
| DTXSID3044203 |
| FT-0082357 |
| FT-0601607 |
| GHUUBYQTCDQWRA-UHFFFAOYSA-N |
| HMS1922L05 |
| HY-14601 |
| I06-0413 |
| I868 |
| J10107 |
| KS-00000IO7 |
| KS-1186 |
| LS-151328 |
| LS-172192 |
| MCULE-1259842295 |
| MFCD04975446 |
| MLS001306462 |
| MLS001401386 |
| MolPort-003-666-558 |
| MolPort-027-851-177 |
| NC00181 |
| NCGC00095131-01 |
| NCGC00095131-02 |
| NCGC00163128-08 |
| NCGC00254492-01 |
| P1901 |
| Pioditazone hydrochloride |
| Pioglitazone (hydrochloride) |
| Pioglitazone for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Pioglitazone HCl |
| Pioglitazone Hydrochloride ,(S) |
| Pioglitazone hydrochloride (Actos) |
| Pioglitazone hydrochloride (JP17/USP) |
| Pioglitazone hydrochloride [USAN:USP] |
| Pioglitazone hydrochloride [USAN] |
| Pioglitazone hydrochloride, >=98% (HPLC) |
| Pioglitazone hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Pioglitazone hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Pioglitazone hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| pioglitazone, hydrochloride |
| Piomed |
| Q-201584 |
| RTR-001112 |
| s2046 |
| SAM001246600 |
| SB17324 |
| SC-19064 |
| SCHEMBL21843 |
| SMR000469167 |
| SPECTRUM1504401 |
| ST2411660 |
| SW197561-4 |
| TL8000362 |
| Tox21_111440 |
| Tox21_111440_1 |
| Tox21_300584 |
| TR-001112 |
| U 72107A |
| U-72107 |
| U-72107A |
| U-72107E |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celltrion | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 076798-003 | Oct 26, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Pharms Inc | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 076801-002 | Aug 17, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 078670-003 | Feb 13, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Zydus Pharms Usa Inc | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 202456-003 | Feb 13, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Prinston Inc | PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 207806-003 | Apr 17, 2018 | 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 | 021073-003 | 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 | 021073-001 | Jul 15, 1999 | Start Trial | Start Trial |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.