Pregabalin - Generic Drug Details

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 Upjohn, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Allied, Amneal Pharms Co, Apotex, Celltrion, Changzhou Pharm, Cipla, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, Teva Pharms, Invatech, Alvogen, and Rubicon, and is included in thirty-six 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-seven 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:	25
NDAs:	36
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	487
Patent Applications:	8,035
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
Aga Khan University	Early Phase 1
Laboratorios Silanes S.A. de C.V.	Phase 3
Al-Kindy College of Medicine	Phase 4

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		225MG	CAPSULE;ORAL
		200MG	CAPSULE;ORAL
		150MG	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

Anatomical Therapeutic Chemical (ATC) Classes for pregabalin

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PREGABALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYRICA CR	Extended-release Tablets	pregabalin	82.5 mg and 165 mg	209501	1	2018-02-02
LYRICA CR	Extended-release Tablets	pregabalin	330 mg	209501	1	2018-01-29
LYRICA	Oral Solution	pregabalin	20 mg/mL	022488		2010-05-19
LYRICA	Capsules	pregabalin	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg	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
Dr Reddys	PREGABALIN	pregabalin	CAPSULE;ORAL	209664-003	Jul 19, 2019	AB	RX	No	No
Msn	PREGABALIN	pregabalin	TABLET, EXTENDED RELEASE;ORAL	213226-003	Apr 13, 2021	AB	RX	No	No
Hetero Labs Ltd Iii	PREGABALIN	pregabalin	CAPSULE;ORAL	206912-003	Oct 8, 2019	AB	RX	No	No
Alvogen	PREGABALIN	pregabalin	TABLET, EXTENDED RELEASE;ORAL	211687-002	Jul 6, 2021		DISCN	No	No

Expired US Patents for pregabalin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010

International Patents for pregabalin

Country	Patent Number	Title	Estimated Expiration
Cyprus	1115009
Eurasian Patent Organization	200800931	ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ
Poland	1945186
Hong Kong	1126394	SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT

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	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 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	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706