➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Medtronic
Moodys
McKesson
Colorcon

Last Updated: July 6, 2020

DrugPatentWatch Database Preview

TACROLIMUS Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Tacrolimus, and what generic alternatives are available?

Tacrolimus is a drug marketed by Accord Hlthcare, Belcher, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Hospira Inc, Fougera Pharms Inc, and Glenmark Pharms Ltd. and is included in twelve NDAs.

The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

US ANDA Litigation and Generic Entry Outlook for Tacrolimus

A generic version of TACROLIMUS was approved as tacrolimus by SANDOZ on August 10th, 2009.

  Start Trial

Drug patent expirations by year for TACROLIMUS
Drug Prices for TACROLIMUS

See drug prices for TACROLIMUS

Drug Sales Revenue Trends for TACROLIMUS

See drug sales revenues for TACROLIMUS

Recent Clinical Trials for TACROLIMUS

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

SponsorPhase
University of Maryland, BaltimorePhase 2
NYU Langone HealthN/A
King Faisal Specialist Hospital & Research CenterPhase 4

See all TACROLIMUS clinical trials

Pharmacology for TACROLIMUS
Medical Subject Heading (MeSH) Categories for TACROLIMUS
Paragraph IV (Patent) Challenges for TACROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
ASTAGRAF XL CAPSULE, EXTENDED RELEASE;ORAL tacrolimus 204096 2013-09-24
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-11-22
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-09-09

US Patents and Regulatory Information for TACROLIMUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd TACROLIMUS tacrolimus OINTMENT;TOPICAL 210393-001 Apr 16, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare TACROLIMUS tacrolimus CAPSULE;ORAL 091195-001 Aug 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz TACROLIMUS tacrolimus CAPSULE;ORAL 065461-002 Aug 10, 2009 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Medtronic
Moodys
McKesson
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.