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Pregabalin - Generic Drug Details

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What are the generic drug sources for pregabalin and what is the scope of freedom to operate?

Pregabalin is the generic ingredient in three branded drugs marketed by Pfizer, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Celltrion, Cipla, Cspc Ouyi, Dr Reddys, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, and Teva Pharms, and is included in twenty-four NDAs. There are three patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pregabalin has thirty-seven patent family members in thirty-three countries.

There are forty-one drug master file entries for pregabalin. Thirty-four suppliers are listed for this compound. There are twelve tentative approvals for this compound.

Summary for pregabalin

International Patents:	37
US Patents:	3
Tradenames:	3
Applicants:	19
NDAs:	24
Drug Master File Entries:	41
Suppliers / Packagers:	34
Bulk Api Vendors:	90
Clinical Trials:	445
Patent Applications:	6,927
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for pregabalin
Drug Sales Revenues:	Drug sales revenues for pregabalin
What excipients (inactive ingredients) are in pregabalin?	pregabalin excipients list
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
CAMC Health System	Phase 4
Emory University	Phase 4
Alexandria University	Phase 2

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		200MG	CAPSULE;ORAL
		150MG	CAPSULE;ORAL
		100MG	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

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
Hikal	PREGABALIN	pregabalin	CAPSULE;ORAL	213423-001	Mar 23, 2020	AB	RX	No	No
Alkem Labs Ltd	PREGABALIN	pregabalin	CAPSULE;ORAL	207799-004	Jul 19, 2019	AB	RX	No	No
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004	AB	RX	Yes	No
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004	AB	RX	Yes	No
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004	AB	RX	Yes	No

Expired US Patents for pregabalin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004
Pfizer	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004

International Patents for pregabalin

Country	Patent Number	Estimated Expiration
Denmark	1945186
Eurasian Patent Organization	200800931
Japan	2009514847
Hong Kong	1126394
Montenegro	00482

Supplementary Protection Certificates for pregabalin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
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	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706