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Fuji
Harvard Business School
Queensland Health
Cipla
Covington
Farmers Insurance
AstraZeneca
Fish and Richardson
McKesson

Generated: July 19, 2018

DrugPatentWatch Database Preview

Isotretinoin - Generic Drug Details

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

Isotretinoin
is the generic ingredient in eight branded drugs marketed by Sun Pharm Inds Inc, Hoffmann La Roche, Mylan Pharms Inc, Teva Pharms Usa, Amneal Pharms Ny, Douglas Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in ten NDAs. There are five patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has eleven patent family members in eight countries.

There are twelve drug master file entries for isotretinoin. Seven suppliers are listed for this compound.
Pharmacology for isotretinoin
Ingredient-typeRetinoids
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for isotretinoin
Synonyms for isotretinoin
(13-cis)-Retinoate
(13-cis)-Retinoic acid
(13cis)-retinoic acid
(2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic Acid
(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenoic acid
(2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-cyclohex-1-enyl)-nona-2,4,6,8-tetraenoic acid
(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid
(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
(2Z,4E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-2,4,6,8-nonatetraenoic acid
(2Z,4E6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid
(7E,9E,11E,13Z)-retinoic acid
13 cis retinoic acid
13 Cis-Retinoic Acid
13-cis RA
13-cis retinoic acid
13-cis-Retinoic acid
13-cis-Retinoic acid, >=98% (HPLC)
13-cis-retinoic acid,Isotretinoin
13-cis-Retinoic acid|||Retinoid analogues
13-cis-Vitamin A acid
13-RA
13cRA
24210-EP2311808A1
24210-EP2311829A1
24210-EP2314590A1
3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2-CIS-4-TRANS-6-TRANS-8-TRANS-NONATETRAENOIC ACID
3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2Z,4E,6E,8E-NONATETRANENOIC ACID
3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)2-cis-4-trans-6-trans-8-trans-nonatetraenoic acid
4-09-00-02388 (Beilstein Handbook Reference)
4759-48-2
5952-EP0930075A1
5952-EP2295426A1
5952-EP2311840A1
59I482
AB03039
Absorica
Absorica (TN)
AC1NQZZ4
accure
Accutane
Accutane (TN)
AKOS015841158
Ambap302-79-4
Amnesteem
Amnesteem (TN)
AN-15746
BDBM50031459
BML2-E07
BPBio1_000080
BRD-K76723084-001-05-9
BRN 1885770
BSPBio_000072
BSPBio_001331
BSPBio_003345
C07058
CAS-4759-48-2
CC-29726
CCG-205158
CCRIS 4286
CHEBI:6067
CHEMBL547
CIP-Isotretinoin
cis retinoic acid
cis-RA
cis-Retinoate
cis-Retinoic acid
Claravi (TN)
Claravis
Clarus (TN)
CPD000471891
CS-1864
D00348
D00DKK
DB00982
Decutan (TN)
DR001197
DSSTox_CID_3177
DSSTox_GSID_23177
DSSTox_RID_76906
DTXSID4023177
EH28UP18IF
EINECS 225-296-0
EU-0101081
GTPL7600
HMS1361C13
HMS1568D14
HMS1791C13
HMS1921D08
HMS1989C13
HMS2092N07
HMS2095D14
HMS2233A07
HMS3259J09
HMS3263I04
HMS3402C13
HSDB 3929
HY-15127
I14-16776
IDI1_033801
ISORETINOIN
Isosuprea Lidose
Isotane
Isotane (TN)
Isotretinoin (USP)
Isotretinoin [USAN:BAN:INN]
Isotretinoin [USAN:INN:BAN]
Isotretinoin [USAN:USP:INN:BAN]
Isotretinoin for peak identification, European Pharmacopoeia (EP) Reference Standard
Isotretinoin Retinoic acid
Isotretinoin Zinc Salt, 13 cis Isomer
Isotretinoin Zinc Salt, 13-cis-Isomer
Isotretinoin, European Pharmacopoeia (EP) Reference Standard
Isotretinoin, pharmaceutical secondary standard; traceable to USP and PhEur
Isotretinoin, United States Pharmacopeia (USP) Reference Standard
isotretinoina
Isotretinoine
Isotretinoine [INN-French]
isotretinoino
Isotretinoino [INN-Spanish]
Isotretinoinum
Isotretinoinum [INN-Latin]
ISOTRETINON
Isotrex
ISOTREXGEL
Izotek (TN)
LMPR01090021
Lopac0_001081
LP01081
LP124491
LS-143465
MFCD00079542
MLS001074662
MolPort-003-666-394
Myorisan
NC00635
NCGC00094358-01
NCGC00094358-02
NCGC00094358-03
NCGC00094358-04
NCGC00094358-05
NCGC00094358-06
NCGC00094358-07
NCGC00094358-08
NCGC00094358-09
NCGC00094358-10
NCGC00094358-11
NCGC00094358-12
NCGC00094358-13
NCGC00094358-14
NCGC00094358-15
NCGC00257647-01
NCGC00261766-01
Neovitamin A acid
NSC-758156
NSC758156
Oratane (TN)
Pharmakon1600-01502013
Prestwick_642
Prestwick2_000256
Prestwick3_000256
R 3255
R0088
Retinoic acid, (13cis)-
RETINOIC ACID, 13-cis-
Ro 4 3780
Ro 4-3780
Ro 43780
Ro-4-3780
Ro-43780
Roaccutan
Roaccutane
Roaccutane (TN)
Roacutan
RP17638
SAM002548955
SBI-0051051.P003
SC-18589
SCHEMBL38299
SHGAZHPCJJPHSC-XFYACQKRSA-N
SMR000471891
Sotret
Sotret (TN)
SPECTRUM1502013
Spectrum5_001795
Spectrum5_001937
Teriosal
Tox21_200093
Tox21_501081
UNII-EH28UP18IF
Zenatane
ZINC3792789

US Patents and Regulatory Information for isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 BX RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-002 May 25, 2012 BX RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for isotretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ➤ Sign Up ➤ Sign Up
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Cantor Fitzgerald
US Army
Fish and Richardson
Covington
Fuji
QuintilesIMS
Johnson and Johnson
Healthtrust

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 verifification 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.