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RETIN-A Drug Profile

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Which patents cover Retin-a, and what generic alternatives are available?

Retin-a is a drug marketed by Valeant Bermuda, Valeant Pharms North, and Valeant Intl. and is included in seven NDAs.

The generic ingredient in RETIN-A is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for RETIN-A

US Patents:	0
Applicants:	3
NDAs:	7
Suppliers / Packagers:	5
Bulk Api Vendors:	108
Patent Applications:	4,430
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RETIN-A
DailyMed Link:	RETIN-A at DailyMed

Pharmacology for RETIN-A

Drug Class

Retinoid

Medical Subject Heading (MeSH) Categories for RETIN-A

Antineoplastic Agents

Keratolytic Agents

Synonyms for RETIN-A

.beta.-all-trans-Retinoic acid

.beta.-Retinoic acid

(11Z)-retinoic acid

(2E,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-cyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetr aenoic acid

(2E,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraenoic acid

(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid

(2E,4E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-2,4,6,8-nonatetraenoic acid

(4E,6E,8E)-9-(2,6,6-Trimethyl-1-cyclohexenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid

(5E)-Retinoic acid

(9Z,13Z)-Retinoic acid

(all-E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid

[3H]RA

[3H]Retinoic acid

[3H]tretinoin

[3H]Vitamin A acid

[All-E]-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid

02T794

13497-05-7 (hydrochloride salt)

15-Apo-beta-caroten-15-oic acid

187175-63-9

1cbr

1n4h

2,4, 6,8-Nonatetranoic acid, 3,7-dimethyl-9-(2,6, 6-trimethyl-1-cyclohexen-1-yl)-, (2E, 4E, 6E, 8E)-

2,4,6,8-Nonatetraenoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)--, (all trans)-

2,4,6,8-Nonatetraenoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-

2,4,6,8-Nonatetranoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-

2,4,6,8-Nonatetranoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all trans)-

2,6,8-Nonatetraenoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-

2,6,8-Nonatetranoic acid, 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-

3,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid

3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid

3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid-, (all trans)-

3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2E,4E,6E,8E,-nonatetraenoic acid

3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexene-1-yl)-2,4,6,8-nonatetraenoic acid (ECL)

3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenoic acid

3,7-Dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-all-trans-tetraenoic acid

3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2E,4E,6E,8E-tetraenoic acid

302-79-4

33998-EP2275420A1

33998-EP2295055A2

33998-EP2295416A2

33998-EP2295426A1

33998-EP2295427A1

33998-EP2298748A2

33998-EP2298764A1

33998-EP2298765A1

33998-EP2298768A1

33998-EP2301928A1

33998-EP2305642A2

33998-EP2308833A2

33998-EP2308861A1

33998-EP2311453A1

33998-EP2311808A1

33998-EP2311829A1

33998-EP2311840A1

4759-48-2

56573-65-0

5688UTC01R

5914-EP2275412A1

5914-EP2292576A2

6-s-trans-retinoic acid

7005-78-9

9-cis-RA

9-cis-retinoic acid (9cRA)

9-trans-retinoic acid

97950-17-9

A-Acido (Argentina)

A-Vitaminsyre

A-Vitaminsyre [Denmark]

AB00052318_18

AB00052318_19

AB00052318-15

AB00052318-16

AB00052318-17

AB1009361

Aberel

Aberela

Aberela (TN)

Aberela [Norway]

AC-6824

AC1L9GWO

AC1Q1J2J

Acid A Vit (Belgium, Netherlands)

Acid, all-trans-Retinoic

Acid, beta-all-trans-Retinoic

Acid, Retinoic

Acid, trans-Retinoic

Acid, Vitamin A

Acide retinoique (French) (DSL)

Acnavit

Acnavit [Denmark]

ACT00012

AGN 100335

AGN100335

Airol

AJ-61307

AK-73126

Aknefug

Aknoten

AKOS000280845

All Trans Retinoic Acid

all trans-Retinoic acid

all-(E)-Retinoic acid

all-cis-retinoic acid

All-trans Retinoic Acid

All-trans Retinoic Acid (Tretinoin)

all-trans-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic Acid

all-trans-b-Retinoic acid

all-trans-beta-Retinoic acid

all-trans-Retinoate

all-trans-Retinoic acid

all-trans-retinoic acid (ATRA)

all-trans-Tretinoin

all-trans-Vitamin A acid

all-trans-Vitamin A1 acid

Alltrans-retinoic acid

AN-9660

ARONIS25153

AT-RA

ATRA

ATRA; Tretinoin; Vitamin A acid; all-trans-Retinoic acid

Atragen

Atralin

Avita (TN)

Avita Gel

Avitoin

Avitoin [Norway]

b-Retinoic acid

BC202905

BCPP000036

BDBM31883

beta all trans Retinoic Acid

beta-all-trans-Retinoic acid

beta-Ra

beta-Retinoic acid

Betarretin

BIDD:GT0483

BIDD:PXR0081

BML2-E05

bmse000562

BP-20401

BPBio1_000082

BR-73126

BRD-K06926592-001-01-7

BRD-K71879491-001-22-6

BRN 2057223

BSPBio_000074

BSPBio_001500

C00777

CAS-302-79-4

CCG-39912

CCRIS 3294

CHEBI:15367

CHEMBL38

cid_444795

Cordes vas

Cordes VAS [Germany]

CPD000058245

CS-1269

D00094

D02DGU

D0A8ND

Dermairol

DSSTox_CID_1239

DSSTox_GSID_21239

DSSTox_RID_76031

DTXSID7021239

Effederm

Effederm [France]

EINECS 206-129-0

Epi-aberel

EU-0101061

Eudyna

GS-3578

GTPL2644

HMS1361K22

HMS1568D16

HMS1791K22

HMS1921D14

HMS1989K22

HMS2089D20

HMS2092N11

HMS2095D16

HMS2236N03

HMS3259E11

HMS3263E04

HMS3402K22

HMS502N05

HSDB 2169

HY-14649

I04-0008

I14-2351

IDI1_000903

IDI1_033970

Isotretinoin Retinoicacid

Isotretinoin;(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

J10054

KB-66303

L000833

LMPR01090019

Lopac0_001061

LP01061

LP091236

LS-1154

MFCD00001551

MLS000028588

MLS001076515

MLS002207234

MLS002222211

MLS002548861

MLS006010222

MolPort-000-883-857

NC00481

NCGC00017280-05

NCGC00017280-06

NCGC00017280-07

NCGC00017280-08

NCGC00017280-09

NCGC00017280-10

NCGC00017280-12

NCGC00017280-15

NCGC00017280-16

NCGC00017280-17

NCGC00017280-18

NCGC00017280-19

NCGC00017280-20

NCGC00017280-23

NCGC00021808-04

NCGC00021808-05

NCGC00021808-06

NCGC00021808-07

NCGC00021808-09

NCGC00021808-11

NCGC00021808-14

NCGC00021808-15

NCGC00254179-01

NCGC00259879-01

NCGC00261746-01

Nexret

NSC 122758

NSC-122758

NSC-759631

NSC122758

NSC759631

Opera_ID_1055

OR007900

PDT-002-002

Pharmakon1600-01502016

Potassium Salt, Tretinoin

Prestwick_424

Prestwick2_000257

Prestwick3_000257

PubChem16466

Q-200610

QCR-120

R 2625

R0064

REA

Refissa

Renova

Renova (TN)

Retacnyl

Retin A

Retin A (TN)

Retin-A (TN)

Retin-A Micro

Retinoate

Retinoic acid

Retinoic acid all trans

Retinoic acid, >=98% (HPLC), powder

Retinoic acid, 98% 250mg

RETINOIC ACID, ALL TRANS

Retinoic acid, all-trans-

Retinoic acid, all-trans- (8CI)

Retinoic acid, all-trans-(8CI)

Retinoic acid, cis-

Retinova

Retionic acid

Retisol-A

Ro 1-5488

RP17637

S-1635

s1653

Salt, Tretinoin Potassium

Salt, Tretinoin Sodium

Salt, Tretinoin Zinc

SAM002264647

SBB065722

SBI-0051031.P003

SC-16932

SCHEMBL19091395

SCHEMBL3145

SHGAZHPCJJPHSC-YCNIQYBTSA-N

SMR000058245

Sodium Salt, Tretinoin

SPECTRUM1502016

Spectrum5_001746

Spectrum5_001933

SR-01000000239

SR-01000000239-14

SR-01000000239-6

ST057075

ST2407905

Stieva-A

Stieva-A (TN)

TNP00194

Tox21_110812

Tox21_110812_1

Tox21_202330

Tox21_300305

Tox21_501061

trans Retinoic Acid

trans-Retinoic acid

trans-Retinoic acid|||Retinoid analogues

Trans-Retinoicacid

Tretin M

tretinoin

Tretinoin - Retinoic Acid

Tretinoin (JAN/USP/INN)

Tretinoin (Retinoic acid)

Tretinoin (TN)

Tretinoin [USAN:INN:BAN]

Tretinoin [USAN:USP:INN:BAN]

Tretinoin 0.1% cream or placebo

tretinoin liposome

tretinoin potassium

Tretinoin Potassium Salt

tretinoin sodium

Tretinoin Sodium Salt

Tretinoin Zinc Salt

Tretinoin, all-trans-

Tretinoin, European Pharmacopoeia (EP) Reference Standard

Tretinoin, pharmaceutical secondary standard; traceable to USP and PhEur

Tretinoin, United States Pharmacopeia (USP) Reference Standard

Tretinoin/All-Trans Retinoic Acid

Tretinoina

Tretinoina [INN-Spanish]

Tretinoine

tretinoine (French) (EINECS)

Tretinoine [INN-French]

Tretinoino

Tretinoino [INN-Spanish]

Tretinoinum

Tretinoinum [INN-Latin]

TRETINON

Tri-Luma

UNII-5688UTC01R

UPCMLD-DP097

Vesanoid

Vesanoid (TN)

Vesanoid (TN) (Roche)

Vesanoid, Airol, Renova, Atralin, Retin-A, Avita, Tretinoin

Vesnaroid

Vitamin A acid

Vitamin A acid, all-trans-

Vitamin a acid, trans-

Vitamin A1 acid, all-trans-

WLN: L6UTJ A1 B1U1Y1 & U2U1Y1 & U1VQ C1 C1

WLN: L6UTJ A1 B1U1Y1&U2U1Y1&U1VQ C1 C1

Zinc Salt, Tretinoin

ZINC12358651

US Patents and Regulatory Information for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	AB	RX	Yes	Yes
Valeant Intl	RETIN-A	tretinoin	SWAB;TOPICAL	016921-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Valeant Intl	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002	AB	RX	Yes	Yes

Expired US Patents for RETIN-A

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017579-002	Approved Prior to Jan 1, 1982
Valeant Bermuda	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988

Paragraph IV (Patent) Challenges for RETIN-A

Drugname	Dosage	Strength	RLD	Date
	Gel	0.04%
	Gel	0.1%