Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

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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 patent protection?

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.

Recent Clinical Trials for pioglitazone hydrochloride

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SponsorPhase
Milton S. Hershey Medical CenterPhase 1/Phase 2
National Center for Advancing Translational Science (NCATS)Phase 1/Phase 2
Khyber Medical University PeshawarPhase 4

See all pioglitazone hydrochloride clinical trials

Recent Litigation for pioglitazone hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Takeda Pharmaceutical Company Limited v. Mylan, Inc.2012-01-03
Takeda Pharmaceutical Company Limited v. Hetero Drugs Limited2011-11-16
Takeda Pharmaceutical Company Limited v. Accord Healthcare, Inc.2011-09-12

See all pioglitazone hydrochloride litigation

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial45MGTABLET; ORAL
  Start Trial  Start Trial30MGTABLET; ORAL
  Start Trial  Start Trial15MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Torrent Pharms Ltd PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 091298-002 Feb 13, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Neopharma PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078383-003 Mar 12, 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
Macleods Pharms Ltd PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 202467-002 Feb 6, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms Usa Inc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 202456-002 Feb 13, 2013 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 021073-002 Jul 15, 1999   Start Trial   Start Trial
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 021073-002 Jul 15, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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McKinsey
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Harvard Business School
Medtronic
McKesson

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