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Last Updated: July 10, 2020

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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 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 NDAs.

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

US ANDA 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
Our Lady of the Lake HospitalN/A
Louisiana State University Health Sciences Center in New OrleansN/A
Ontario Institute for Cancer ResearchPhase 2

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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
Invagen Pharms PREGABALIN pregabalin CAPSULE;ORAL 211384-006 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc PREGABALIN pregabalin CAPSULE;ORAL 208677-003 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
Cipla PREGABALIN pregabalin CAPSULE;ORAL 212280-004 Jan 10, 2020 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Mallinckrodt
McKinsey
Merck
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.