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Last Updated: January 24, 2020

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ABSORICA Drug Profile

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When do Absorica patents expire, and what generic alternatives are available?

Absorica is a drug marketed by Sun Pharm Inds Inc and Sun Pharm and is included in two NDAs. There are seven patents protecting this drug and five Paragraph IV challenges.

This drug has twelve patent family members in nine countries.

The generic ingredient in ABSORICA is isotretinoin. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

US ANDA Litigation and Generic Entry Outlook for Absorica

A generic version of ABSORICA was approved as isotretinoin by AMNEAL PHARMS NY on January 24th, 2020.

  Start Trial

Drug patent expirations by year for ABSORICA
Drug Prices for ABSORICA

See drug prices for ABSORICA

Drug Sales Revenue Trends for ABSORICA

See drug sales revenues for ABSORICA

Recent Clinical Trials for ABSORICA

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

SponsorPhase
Ranbaxy Inc.Phase 4

See all ABSORICA clinical trials

Recent Litigation for ABSORICA

Identify potential future generic entrants

District Court Litigation
Case NameDate
GALEPHAR PHARMACEUTICAL RESEARCH, INC. v. UPSHER-SMITH LABORATORIES, LLC2019-01-30
CIPHER PHARMACEUTICALS, INC. v. WATSON LABORATORIES, INC.-FLORIDA2013-10-29

See all ABSORICA litigation

Pharmacology for ABSORICA
Drug ClassRetinoid
Synonyms for ABSORICA
(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 (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
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
Paragraph IV (Patent) Challenges for ABSORICA
Tradename Dosage Ingredient NDA Submissiondate
ABSORICA CAPSULE;ORAL isotretinoin 021951 2016-05-16
ABSORICA CAPSULE;ORAL isotretinoin 021951 2015-11-25
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-06-19
ABSORICA CAPSULE;ORAL isotretinoin 021951 2013-01-07
ABSORICA CAPSULE;ORAL isotretinoin 021951 2012-12-31

US Patents and Regulatory Information for ABSORICA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-006 Nov 5, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-001 Nov 5, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm ABSORICA LD isotretinoin CAPSULE;ORAL 211913-002 Nov 5, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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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Merck
McKinsey

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