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Generated: December 12, 2018

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ADAPALENE - Generic Drug Details

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

Adapalene is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Glenmark Generics, Pliva Hrvatska Doo, Taro, Tolmar, Call Inc, Perrigo Israel, and Galderma Labs, and is included in twenty NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-five patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for ADAPALENE
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for ADAPALENE
Synonyms for ADAPALENE
(non-d)Adapalene-d15
106685-40-9
1L4806J2QF
2-Naphthalenecarboxylic acid, 6-(4-methoxy-3-tricyclo(3.3.1.1(sup 3,7))dec-1-ylphenyl)-
2-Naphthalenecarboxylic acid, 6-(4-methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)-
4CA-0111
6-(3-((3r,5r,7r)-adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid
6-(3-(1-Adamantyl)-4-methoxyphenyl)-2-naphthoic acid
6-(3-(Adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid
6-(3-Adamantan-1-yl-4-methoxy-phenyl)-naphthalene-2-carboxylic acid
6-(3-adamantan-1-yl-4-methoxyphenyl)naphthalene-2-carboxylic acid
6-(4-Methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)-2-naphthalenecarboxylic acid
6-[3-(1-adamantyl)-4-methoxy-phenyl]naphthalene-2-carboxylic acid
6-[3-(1-ADAMANTYL)-4-METHOXYPHENYL]-2-NAPHTHALENE CARBOXYLIC ACID
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalene-carboxylic acid
6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalenecarboxylic acid
6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid
6-[3-(1-adamantyl)-4-methoxyphenyl]naphthalene-2-carboxylic acid
6-[3-(adamantan-1-yl)-4-methoxyphenyl]-2-naphthoic acid
6-[3-(adamantan-1-yl)-4-methoxyphenyl]naphthalene-2-carboxylic acid
6-[4-methoxy-3-(tricyclo[3.3.1.1~3,7~]dec-1-yl)phenyl]naphthalene-2-carboxylic acid
6-[4-methoxy-3-(tricyclo[3.3.1.13,7]dec-1-yl)phenyl]naphthalene-2-carboxylic acid
685A409
A801483
AB0013899
AB01274764_03
AB01274764_04
AB01274764-01
AB01274764-02
AB13763
AB2000023
ABP000590
AC-1974
AC1L1SOH
AC1Q5USH
Adaferin
Adaferin (TN)
Adapalen
Adapalene (JAN/USAN/INN)
Adapalene [USAN:BAN:INN]
Adapalene [USAN:INN:BAN]
Adapalene for peak identification, European Pharmacopoeia (EP) Reference Standard
Adapalene, >=98% (HPLC)
Adapalene, European Pharmacopoeia (EP) Reference Standard
Adapalene, pharmaceutical secondary standard; traceable to USP and PhEur
Adapalene, United States Pharmacopeia (USP) Reference Standard
Adapalene/
Adapaleno
Adapaleno [INN-Spanish]
Adapalenum
Adapalenum [INN-Latin]
AJ-45604
AK-72900
AKOS005145841
AKOS015895391
Ambap106685-40-9
AN-593
AOB6389
API0001385
BC205779
BCP9000231
BDBM50048280
BIDD:GT0264
BR-72900
BRD-K33127281-001-01-5
C28H28O3
CAS-106685-40-9
CCG-213060
CCG-221237
CD 271
CD-271
CD271
CHEBI:31174
CHEMBL1265
CHEMBL76401
CPD000466349
CS-1789
CTK8E8906
D01112
D0JC9N
DB00210
Differin
Differin (TN)
Differin Gel
Differin Gel 0.1%
Differin, Adapalene
Differin, Teva, Pimpal, Gallet, Adelene, Adeferin
Differine
DR002478
DSSTox_CID_26481
DSSTox_GSID_46481
DSSTox_RID_81652
DTXSID5046481
EBD19549
F2173-0588
FT-0631040
GTPL5429
HMS3264F15
HMS3654F11
HY-B0091
I06-0642
I810
KB-246947
KS-000002B5
KS-1196
LS-172017
LZCDAPDGXCYOEH-UHFFFAOYSA-N
MFCD03106112
MLS000759463
MLS006010036
MolPort-003-986-211
NAP030
NCGC00164617-01
NCGC00164617-02
NCGC00164617-04
NCGC00164617-05
PL029988
PL040836
RTR-001330
S-3513
s1276
SAM001246663
SC-17327
SCHEMBL2747
SMR000466349
SMR002529673
SR-01000942194
SR-01000942194-2
ST2412159
STL453114
TL8000241
Tox21_112236
Tox21_112236_1
TR-001330
UNII-1L4806J2QF
ZINC3784182
Tentative approvals for ADAPALENE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up1%;2%GEL;TOPICAL

US Patents and Regulatory Information for ADAPALENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro ADAPALENE adapalene GEL;TOPICAL 208322-001 Jun 23, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206959-001 Jan 24, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 AB RX Yes Yes ➤ 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

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Expired US Patents for ADAPALENE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ADAPALENE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/005 United Kingdom ➤ Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0024 France ➤ Sign Up PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Mallinckrodt
Chinese Patent Office
Cantor Fitzgerald
McKesson
Harvard Business School
Colorcon
Boehringer Ingelheim
Express Scripts

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