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Last Updated: April 19, 2021

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PREGABALIN Drug Profile

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When do Pregabalin patents expire, and when can generic versions of Pregabalin launch?

Pregabalin is a drug marketed by Actavis Elizabeth, 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-one NDAs.

The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pregabalin

A generic version of PREGABALIN was approved as pregabalin by ALEMBIC PHARMS LTD on July 19th, 2019.

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Drug patent expirations by year for PREGABALIN
Drug Prices for PREGABALIN

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Drug Sales Revenue Trends for PREGABALIN

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Recent Clinical Trials for PREGABALIN

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SponsorPhase
CAMC Health SystemPhase 4
Emory UniversityPhase 4
Alexandria UniversityPhase 2

See all PREGABALIN clinical trials

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
Hikal PREGABALIN pregabalin CAPSULE;ORAL 213423-006 Mar 23, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Rising PREGABALIN pregabalin CAPSULE;ORAL 210432-003 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla PREGABALIN pregabalin CAPSULE;ORAL 212280-005 Jan 10, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co PREGABALIN pregabalin CAPSULE;ORAL 209743-008 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Msn PREGABALIN pregabalin CAPSULE;ORAL 209357-004 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc PREGABALIN pregabalin CAPSULE;ORAL 208677-008 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi PREGABALIN pregabalin CAPSULE;ORAL 210585-005 Dec 26, 2019 AB RX 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

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