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

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Last Updated: December 9, 2019

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Tazarotene - Generic Drug Details

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What are the generic sources for tazarotene and what is the scope of patent protection?

Tazarotene is the generic ingredient in four branded drugs marketed by Mayne Pharma, Allergan, Acp Nimble, Fougera Pharms Inc, and Taro Pharms, and is included in six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has twenty-three patent family members in seventeen countries.

There are eight drug master file entries for tazarotene. Seven suppliers are listed for this compound.

Drug Prices for tazarotene

See drug prices for tazarotene

Recent Clinical Trials for tazarotene

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dana-Farber Cancer InstitutePhase 2
Assiut UniversityPhase 4
Dr. Reddy's Laboratories LimitedPhase 2

See all tazarotene clinical trials

Recent Litigation for tazarotene

Identify potential future generic entrants

District Court Litigation
Case NameDate
Simonian v. Allergan, Inc.2010-03-09
Allergan Inc. v. Apotex Inc.2007-05-21
Allergan Inc. v. Alcon Inc.2004-08-24

See all tazarotene litigation

Pharmacology for tazarotene
Drug ClassRetinoid
Synonyms for tazarotene
118292-40-3
15146-EP2275420A1
15146-EP2295055A2
15146-EP2295416A2
15146-EP2298748A2
15146-EP2298764A1
15146-EP2298765A1
15146-EP2298768A1
15146-EP2305642A2
15146-EP2308861A1
15146-EP2311453A1
15146-EP2311808A1
15146-EP2311829A1
15146-EP2314590A1
15146-EP2316832A1
15146-EP2316833A1
292T403
3-Pyridinecarboxylic acid, 6-((3,4-dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl)-, ethyl ester
3-Pyridinecarboxylic acid, 6-((3,4-dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl)-,ethyl ester
4CA-1215
6-(4,4-Dimethyl-thiochroman-6-ylethynyl)-nicotinic acid ethyl ester
6-(4,4-dimethylthiochroman-6-ylethynyl) nicotinic acid ethyl ester
6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester
6-[2-(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]- 3-pyridinecarboxylic Acid Ethyl Ester
6-[2-(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester
6-[2-(3,4-dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylicacidethylester
81BDR9Y8PS
AB0012671
AB01274801_02
AB01274801-01
AB2000146
ABP000994
AC-755
AC1L1K88
Acnitaz
ACT06773
AGN 190168
AGN-190168
AGN190168, AGN-190168
AJ-26850
AKOS015902872
AN-15540
ANW-45265
Avage
Avage (TN)
AX8041205
BC201578
BCP0726000163
BCP22966
BDBM50265951
BIDD:GT0293
BR-73028
BS-1012
C-23771
C12531
C21H21NO2S
CAS-118292-40-3
CC-34651
CHEBI:32184
CHEMBL1657
CJ-24315
CS-1029
CTK8B4490
D01132
DB00799
DSSTox_CID_26691
DSSTox_GSID_46691
DSSTox_RID_81825
DTXSID5046691
EBD38650
Ethyl 6-((4,4-dimethylthiochroman-6-yl)ethynyl)nicotinate
Ethyl 6-((4,4-dimethylthiochroman-6-yl)ethynyl)nicotinate;6-(4,4-dimethyl-thiochroman-6-ylethynyl)-nicotinic acid ethyl ester
ethyl 6-(2-(4,4-dimethylthiochroman-6-yl)-ethynyl)nicotinate
ethyl 6-(2-(4,4-dimethylthiochroman-6-yl)ethynyl)nicotinate
ethyl 6-[(4,4-dimethyl-3,4-dihydro-2H-thiochromen-6-yl)ethynyl]nicotinate
Ethyl 6-[(4,4-dimethyl-3,4-dihydro-2H-thiochromen-6-yl)ethynyl]pyridine-3-carboxylate
ethyl 6-[2-(4,4-dimethyl-2,3-dihydrothiochromen-6-yl)ethynyl]pyridine-3-carboxylate
ethyl 6-[2-(4,4-dimethyl-3,4-dihydro-2H-1-benzothiopyran-6-yl)ethynyl]pyridine-3-carboxylate
Ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)-ethynyl]nicotinate
ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl] nicotinate
Ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate
ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl]pyridine-3-carboxylate
Fabior
Fabior (TN)
FT-0652578
GTPL6952
HMS3655K05
HY-15388
I14-1992
KB-80817
LS-130838
MLS003915630
MolPort-005-932-693
NCGC00167525-01
NCGC00167525-02
NCGC00167525-03
OGQICQVSFDPSEI-UHFFFAOYSA-N
PubChem24431
Q-102516
RTR-034197
S-7551
s1569
SC-19506
SCHEMBL3134
SMR002096194
SR-01000931253
SR-01000931253-2
ST2419369
Suretin
SW220026-1
Tazarotene (Avage)
Tazarotene (JAN/USAN/INN)
Tazarotene [USAN:INN:BAN]
Tazarotene [USAN:INN]
Tazarotene,(S)
tazaroteno
tazarotenum
Tazorac
Tazorac (TN)
Tazorac;Avage;Zora;Avage
Tazoral
Tox21 112522
Tox21_112522
Tox21_112522_1
TR-034197
UNII-81BDR9Y8PS
ZINC1542199
Zora
Zorac
Zorac|||Tazorac

US Patents and Regulatory Information for tazarotene

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-001 Jun 13, 1997 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan TAZORAC tazarotene CREAM;TOPICAL 021184-001 Sep 29, 2000 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan AVAGE tazarotene CREAM;TOPICAL 021184-003 Sep 30, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Fougera Pharms Inc TAZAROTENE tazarotene CREAM;TOPICAL 211175-001 Jan 28, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997 RX Yes Yes   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 tazarotene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997   Start Trial   Start Trial
Allergan AVAGE tazarotene CREAM;TOPICAL 021184-003 Sep 30, 2002   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-002 Jun 13, 1997   Start Trial   Start Trial
Allergan TAZORAC tazarotene GEL;TOPICAL 020600-001 Jun 13, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tazarotene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0284288 SPC/GB98/002 United Kingdom   Start Trial PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
0284288 12/1998 Austria   Start Trial PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0031058 98C0008 Belgium   Start Trial PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
McKesson
Baxter
Mallinckrodt
Medtronic

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