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, ACI, Actavis Elizabeth, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Mylan, Prinston Inc, Renata, Rising, Sciegen Pharms Inc, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Patrin, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-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. Fifty-one suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for pregabalin

International Patents:	37
US Patents:	3
Tradenames:	3
Applicants:	33
NDAs:	46
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	516
Patent Applications:	6,331
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
Istanbul Physical Medicine Rehabilitation Training and Research Hospital	N/A
Egymedicalpedia	Early Phase 1
Beijing Tiantan Hospital	N/A

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		300MG	CAPSULE;ORAL
		225MG	CAPSULE;ORAL
		200MG	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

N02BF	Gabapentinoids
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

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	1	2010-05-19
LYRICA	Capsules	pregabalin	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg	021446	8	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
Aci	PREGABALIN	pregabalin	CAPSULE;ORAL	215755-006	Apr 26, 2023	AB	RX	No	No
Alkem Labs Ltd	PREGABALIN	pregabalin	CAPSULE;ORAL	207799-006	Jul 19, 2019	AB	RX	No	No
Apotex	PREGABALIN	pregabalin	CAPSULE;ORAL	211685-002	Jul 7, 2021	AB	RX	No	No
Changzhou Pharm	PREGABALIN	pregabalin	CAPSULE;ORAL	214322-003	Jul 15, 2021	AB	RX	No	No
Invagen Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	211384-007	Jul 19, 2019	AB	RX	No	No
Mylan	PREGABALIN	pregabalin	CAPSULE;ORAL	091228-005	Sep 20, 2019		DISCN	No	No
Rising	PREGABALIN	pregabalin	CAPSULE;ORAL	210432-005	Jul 19, 2019	AB	RX	No	No

Expired US Patents for pregabalin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004

EU/EMA Drug Approvals for pregabalin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Zentiva k.s.	Pregabalin Zentiva k.s.	pregabalin	EMEA/H/C/004277 Neuropathic painPregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderPregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.	Withdrawn	yes	no	no	2017-02-27
Zentiva, k.s.	Pregabalin Zentiva	pregabalin	EMEA/H/C/003900 Neuropathic pain, , , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults., , , Epilepsy, , , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation., , , Generalised anxiety disorder, , , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults., ,	Authorised	yes	no	no	2015-07-17
Mylan S.A.S.	Pregabalin Mylan Pharma	pregabalin	EMEA/H/C/003962 EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Withdrawn	yes	no	no	2015-06-25
Upjohn EESV	Pregabalin Pfizer	pregabalin	EMEA/H/C/003880 Neuropathic painPregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Authorised	no	no	no	2014-04-10
Upjohn EESV	Lyrica	pregabalin	EMEA/H/C/000546 Neuropathic painLyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyLyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderLyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.	Authorised	no	no	no	2004-07-05
Sandoz GmbH	Pregabalin Sandoz GmbH	pregabalin	EMEA/H/C/004070 EpilepsyPregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Withdrawn	yes	no	no	2015-06-19
Accord Healthcare S.L.U.	Pregabalin Accord	pregabalin	EMEA/H/C/004024 EpilepsyPregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Authorised	yes	no	no	2015-08-28

International Patents for pregabalin

Country	Patent Number	Title	Estimated Expiration
Dominican Republic	P2006000241	COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
South Korea	101012533
Eurasian Patent Organization	200800931	ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ
Uruguay	29890	COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Montenegro	00482	ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Poland	1945186
Australia	2006310217	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
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	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
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	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725