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Last Updated: August 2, 2021

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LEFLUNOMIDE Drug Patent Profile


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When do Leflunomide patents expire, and what generic alternatives are available?

Leflunomide is a drug marketed by Abhai Llc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Axunio, Barr, Fosun Pharma, Heritage Pharms Inc, Lupin Ltd, Sandoz, Teva Pharms, and Zydus. and is included in twelve NDAs.

The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Leflunomide

A generic version of LEFLUNOMIDE was approved as leflunomide by APOTEX INC on September 13th, 2005.

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Drug patent expirations by year for LEFLUNOMIDE
Drug Prices for LEFLUNOMIDE

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Drug Sales Revenue Trends for LEFLUNOMIDE

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Recent Clinical Trials for LEFLUNOMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tata Memorial CentrePhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Chinese SLE Treatment And Research GroupN/A

See all LEFLUNOMIDE clinical trials

Pharmacology for LEFLUNOMIDE

US Patents and Regulatory Information for LEFLUNOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abhai Llc LEFLUNOMIDE leflunomide TABLET;ORAL 212453-001 Jun 3, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin Ltd LEFLUNOMIDE leflunomide TABLET;ORAL 211863-002 Feb 4, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus LEFLUNOMIDE leflunomide TABLET;ORAL 212308-002 Apr 24, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Boehringer Ingelheim
Harvard Business School
Merck
McKesson
Moodys
Colorcon

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.