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Last Updated: March 28, 2024

Pregabalin - Generic Drug Details


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What are the generic 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, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Patrin, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-seven 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.

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
Istanbul Physical Medicine Rehabilitation Training and Research HospitalN/A
EgymedicalpediaEarly Phase 1
Beijing Tiantan HospitalN/A

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial300MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial225MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial200MGCAPSULE;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 212280-004 Jan 10, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms PREGABALIN pregabalin CAPSULE;ORAL 206752-007 Dec 9, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Adaptis PREGABALIN pregabalin CAPSULE;ORAL 216197-006 Jul 18, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for pregabalin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0934061 PA2004017 Lithuania ⤷  Try a Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330 2004C/022 Belgium ⤷  Try a Trial PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330 C300164 Netherlands ⤷  Try a Trial PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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