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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 patent protection?

Pregabalin is the generic ingredient in three branded drugs marketed by Pf Prism Cv, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Dr Reddys, Hainan, Hetero Labs Ltd Iii, Invagen Pharms, Msn Labs Pvt Ltd, Mylan, Rising, Sciegen Pharms Inc, and Teva Pharms, and is included in eighteen 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. Thirty-one suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Summary for pregabalin

International Patents:	104
US Patents:	6
Tradenames:	3
Applicants:	13
NDAs:	18
Drug Master File Entries:	41
Suppliers / Packagers:	31
Bulk Api Vendors:	86
Clinical Trials:	407
Patent Applications:	6,171
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

See drug prices for pregabalin

See drug sales revenues for pregabalin

Recent Clinical Trials for pregabalin

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

Sponsor	Phase
University of Missouri-Columbia	Phase 2/Phase 3
University of Utah	Phase 4
Ciusss de L'Est de l'Île de Montréal	N/A

See all pregabalin clinical trials

Recent Litigation for pregabalin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Pfizer Inc. v. Alphapharm Pty Ltd.	2010-03-12
Pfizer Inc. v. Teva Pharmaceuticals USA Inc.	2009-04-29
Pfizer Inc. v. Lupin Ltd.	2009-04-29

See all pregabalin litigation

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		50MG	CAPSULE; ORAL
		25MG	CAPSULE; ORAL
		300MG	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.

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

Paragraph IV (Patent) Challenges for PREGABALIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	pregabalin	209501	2018-02-02
LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	pregabalin	209501	2018-01-29
LYRICA	SOLUTION;ORAL	pregabalin	022488	2010-05-19
LYRICA	CAPSULE;ORAL	pregabalin	021446	2008-12-30

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	021446-007	Dec 30, 2004	AB	RX	Yes	No
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004	AB	RX	Yes	No
Teva Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	091219-002	Jul 19, 2019	AB	RX	No	No
Invagen Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	211384-007	Jul 19, 2019	AB	RX	No	No
Invagen Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	211384-001	Jul 19, 2019	AB	RX	No	No
Hetero Labs Ltd Iii	PREGABALIN	pregabalin	CAPSULE;ORAL	206912-007	Oct 8, 2019	AB	RX	No	No
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004	AB	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	CAPSULE;ORAL	021446-003	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	021446-004	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004

International Patents for pregabalin

Country	Patent Number	Estimated Expiration
Luxembourg	91112
Japan	4297814
Eurasian Patent Organization	012377
Denmark	0934061
Ecuador	SP088422
Japan	4334610
Denmark	1945186

Supplementary Protection Certificates for pregabalin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330	91112	Luxembourg		91112, EXPIRES: 20180518
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	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0641330	SPC/GB04/034	United Kingdom		PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517