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Last Updated: November 24, 2024

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 Upjohn, Acme Labs, 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, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Norvium Bioscience, Prinston Inc, Rising, Rk Pharma, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Anda Repository, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-eight 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-six suppliers are listed for this compound. There are eight tentative approvals for this compound.

Drug Prices for pregabalin

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Drug Sales Revenue Trends for pregabalin

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Recent Clinical Trials for pregabalin

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

SponsorPhase
Jules Bordet InstitutePhase 2
University of MilanPhase 2
KU LeuvenPhase 2

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up300MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up225MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up200MGCAPSULE;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
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
Cipla PREGABALIN pregabalin CAPSULE;ORAL 212280-006 Jan 10, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising PREGABALIN pregabalin CAPSULE;ORAL 210432-004 Jul 19, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc PREGABALIN pregabalin CAPSULE;ORAL 208677-005 Jul 19, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys PREGABALIN pregabalin CAPSULE;ORAL 209664-008 Jul 19, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising PREGABALIN pregabalin CAPSULE;ORAL 210432-008 Jul 19, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma PREGABALIN pregabalin CAPSULE;ORAL 215755-008 Apr 26, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for pregabalin

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for pregabalin

Country Patent Number Title Estimated Expiration
New Zealand 567414 Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent ⤷  Sign Up
Denmark 1945186 ⤷  Sign Up
Israel 190827 PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT ⤷  Sign Up
Taiwan 200803831 Solid pharmaceutical compositions containing pregabalin ⤷  Sign Up
Cyprus 1115009 ⤷  Sign Up
Eurasian Patent Organization 012377 ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pregabalin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 SPC/GB04/034 United Kingdom ⤷  Sign Up 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/
0934061 PA2004017,C0934061 Lithuania ⤷  Sign Up PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330 27/2004 Austria ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330 CR 2004 00036 Denmark ⤷  Sign Up PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0934061 PA2004017 Lithuania ⤷  Sign Up PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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