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Pregabalin - Generic Drug Details

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

Pregabalin is the generic ingredient in two branded drugs marketed by Pf Prism Cv and is included in three NDAs. There are six patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pregabalin has one hundred and four patent family members in forty-five countries.

There are forty-one drug master file entries for pregabalin. Thirteen suppliers are listed for this compound. There are fifteen tentative approvals for this compound.

Summary for pregabalin

International Patents:	104
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	41
Suppliers / Packagers:	13
Bulk Api Vendors:	83
Clinical Trials:	402
Patent Applications:	6,238
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for pregabalin
Drug Sales Revenues:	Drug sales revenues for pregabalin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pregabalin
DailyMed Link:	pregabalin at DailyMed

Medical Subject Heading (MeSH) Categories for pregabalin

Analgesics

Anti-Anxiety Agents

Anticonvulsants

Calcium Channel Blockers

Synonyms for pregabalin

(3S)-3-(aminomethyl)-5-methyl hexanoic acid

(3S)-3-(aminomethyl)-5-methyl-hexanoic acid

(3S)-3-(aminomethyl)-5-methylhexanoic acid

(R-)-3-isobutyl GABA

(S)-(+)-3-Aminomethyl-5-Methylhexanoic Acid

(S)-(+)-4-amino-3-(2-methylpropyl)butanoic acid

(S)-3-(Aminomethyl)-5-methylhexanoic acid

(S)-3-(Aminomethyl)-5-methylhexanoicacid

(S)-3-Aminomethyl-5-methyl-hexanoic acid

(S)-3-aminomethyl-5-methylhexanoic acid

(S)-3-Isobutyl GABA

(S)-Pregabalin

121GE001

148553-50-8

3-isobutyl GABA

553P508

55JG375S6M

A808784

AB0074009

AB01563007_01

AB1008692

AC-1158

AC1NUP03

ACN-038395

AJ-08241

AKOS001476611

AKOS005145504

AM20080369

AN-1059

AYXYPKUFHZROOJ-ZETCQYMHSA-N

BC634849

BDBM50164279

CAS-148553-50-8

CCG-221247

CHEBI:64356

CHEMBL1059

CI 1008

CI-1008

CM14412

CP0100

CS-1247

CTK9A5767

D02716

DB00230

DEA No. 2782

DSSTox_CID_25950

DSSTox_GSID_45950

DSSTox_RID_81246

DTXSID1045950

EN300-92104

FT-0080911

GTPL5484

Hexanoic acid, 3-(aminomethyl)-5-ethyl-, (3S)-

Hexanoic acid, 3-(aminomethyl)-5-methyl-, (3S)-

Hexanoic acid, 3-(aminomethyl)-5-methyl-, (S)-

HMS3715J16

HSDB 7530

HY-17414

KB-01630

KS-00000AF5

KS-5378

KSC005O6P

LS-75191

Lyrica

Lyrica (TN)

MFCD00917044

NCGC00095186-01

NCGC00346738-01

Nervalin

PD 144723

PD-144723

Pregabalin (JAN/USAN/INN)

Pregabalin [USAN:INN:BAN:JAN]

Pregabalin [USAN]

Pregabalin 1.0 mg/ml in Methanol

Pregabalin, >=97% (NMR)

Pregabalin, EuropePharmacopoeia (EP) Reference Standard

Pregablin

S-(+)-3-isobutylgaba

SC-11867

SCHEMBL8227

SR-01000942257

SR-01000942257-2

ST2408318

TL8001062

TOS-BB-0910

Tox21_111475

UNII-55JG375S6M

W-5218

Z2757554242

ZINC5152

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE; ORAL
		75MG	CAPSULE; ORAL
		50MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for pregabalin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004		RX	Yes	No
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004		RX	Yes	Yes
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004		RX	Yes	No
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017		RX	Yes	Yes					Y
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004		RX	Yes	No
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004		RX	Yes	No
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004		RX	Yes	No

Expired US Patents for pregabalin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004

International Patents for pregabalin

Country	Patent Number	Estimated Expiration
Russian Federation	2140901
World Intellectual Property Organization (WIPO)	9209560
Croatia	P970387
European Patent Office	0641330
Australia	714980
Australia	3602497
Australia	2006310217

Supplementary Protection Certificates for pregabalin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	300164	Netherlands		300164, 20130518, EXPIRES: 20180517
0641330	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330	CA 2004 00036	Denmark
0641330	27/2004	Austria		PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
0641330	C00641330/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330	91112	Luxembourg		91112, EXPIRES: 20180518