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Last Updated: August 3, 2020

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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 Pf Prism Cv, 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-three 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-two suppliers are listed for this compound. There are twelve 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
Our Lady of the Lake HospitalN/A
Louisiana State University Health Sciences Center in New OrleansN/A
Ontario Institute for Cancer ResearchPhase 2

See all PREGABALIN clinical trials

Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGCAPSULE;ORAL
  Start Trial  Start Trial225MGCAPSULE;ORAL
  Start Trial  Start 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 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
Mylan PREGABALIN pregabalin CAPSULE;ORAL 091228-008 Sep 20, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Hikal PREGABALIN pregabalin CAPSULE;ORAL 213423-008 Mar 23, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan PREGABALIN pregabalin CAPSULE;ORAL 091228-007 Sep 20, 2019 DISCN No No   Start Trial   Start Trial   Start 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
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PREGABALIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 CR 2004 00036 Denmark   Start Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330 C300164 Netherlands   Start Trial PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0641330 2004C/022 Belgium   Start Trial PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330 27/2004 Austria   Start Trial 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 Lithuania   Start Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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