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Isotretinoin - Generic Drug Details

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 twelve patent family members in nine countries.

There are thirteen drug master file entries for isotretinoin. Six suppliers are listed for this compound.

Summary for isotretinoin

International Patents:	12
US Patents:	5
Tradenames:	8
Applicants:	8
NDAs:	10
Drug Master File Entries:	13
Suppliers / Packagers:	6
Bulk Api Vendors:	58
Clinical Trials:	112
Patent Applications:	7,529
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for isotretinoin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for isotretinoin
DailyMed Link:	isotretinoin at DailyMed

Pharmacology for isotretinoin

Drug Class	Retinoid

Medical Subject Heading (MeSH) Categories for isotretinoin

Dermatologic Agents
Teratogens

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-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
4-09-00-02388 (Beilstein Handbook Reference)
4759-48-2
5952-EP0930075A1
5952-EP2295426A1
5952-EP2311840A1
59I482
Absorica
Absorica (TN)
AC1NQZZ4
Accutane
Accutane (TN)
AK545586
AKOS015841158
Amnesteem
AN-15746
BCP18950
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
Claravis
CPD000471891
CS-1864
D00348
DB00982
DS-3367
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
HMS3712D14
HSDB 3929
HY-15127
I14-16776
IDI1_033801
ISORETINOIN
Isosuprea Lidose
Isotane
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, European Pharmacopoeia (EP) Reference Standard
Isotretinoin, Pharmaceutical Secondary Standard; Certified Reference Material
Isotretinoin, United States Pharmacopeia (USP) Reference Standard
isotretinoina
Isotretinoine
Isotretinoine [INN-French]
isotretinoino
Isotretinoino [INN-Spanish]
Isotretinoinum
Isotretinoinum [INN-Latin]
ISOTRETINON
Isotrex
LMPR01090021
Lopac0_001081
LP01081
LS-143465
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
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
Roaccutan
Roaccutane
Roacutan
RP17638
SAM002548955
SBI-0051051.P003
SC-18589
SCHEMBL38299
SHGAZHPCJJPHSC-XFYACQKRSA-N
SMR000471891
Sotret
Sotret (TN)
SPECTRUM1502013
Spectrum5_001795
Spectrum5_001937
SR-01000076103
SR-01000076103-10
SR-01000076103-2
SR-01000076103-5
SR-01000076103-6
SR-01000076103-9
Teriosal
Tox21_200093
Tox21_501081
UNII-EH28UP18IF
Zenatane
ZINC3792789

US Patents and Regulatory Information for isotretinoin

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Glossary

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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	021951-004	May 25, 2012	BX	RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012	BX	RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982		DISCN	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-005	Aug 15, 2014		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	021951-005	Aug 15, 2014		RX	Yes	No	➤ 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				➤ Sign Up
>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 isotretinoin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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	018662-003	May 7, 1982	➤ Sign Up	➤ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	➤ Sign Up	➤ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	➤ Sign Up	➤ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for isotretinoin

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Country	Patent Number	Estimated Expiration
Canada	2423170	➤ Sign Up
World Intellectual Property Organization (WIPO)	2015094574	➤ Sign Up
World Intellectual Property Organization (WIPO)	0224172	➤ Sign Up
Portugal	1318791	➤ Sign Up
European Patent Office	2964195	➤ Sign Up
European Patent Office	1318791	➤ Sign Up
Canada	2836228	➤ Sign Up
>Country	>Patent Number	>Estimated Expiration

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