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Last Updated: May 26, 2022

PREGABALIN Drug Patent 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, Allied, Amneal Pharms Co, Apotex, Celltrion, Changzhou Pharm, Cipla, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, Teva Pharms, Invatech, Alvogen, and Rubicon. and is included in thirty-three NDAs.

The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Thirty-seven 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
Aga Khan UniversityEarly Phase 1
Laboratorios Silanes S.A. de C.V.Phase 3
Al-Kindy College of MedicinePhase 4

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Medical Subject Heading (MeSH) Categories for PREGABALIN
Anatomical Therapeutic Chemical (ATC) Classes 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 2010-05-19
LYRICA Capsules pregabalin 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg 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
Dr Reddys PREGABALIN pregabalin CAPSULE;ORAL 209664-007 Jul 19, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Invagen Pharms PREGABALIN pregabalin CAPSULE;ORAL 211384-004 Jul 19, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex PREGABALIN pregabalin CAPSULE;ORAL 211685-003 Jul 7, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms Co PREGABALIN pregabalin CAPSULE;ORAL 209743-002 Jul 19, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn PREGABALIN pregabalin TABLET, EXTENDED RELEASE;ORAL 213226-003 Apr 13, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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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.