➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
AstraZeneca
Moodys
Medtronic
Merck

Last Updated: October 29, 2020

DrugPatentWatch Database Preview

Tacrolimus - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for tacrolimus and what is the scope of patent protection?

Tacrolimus is the generic ingredient in five branded drugs marketed by Astellas, Accord Hlthcare, Belcher, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Hospira Inc, Leo Pharma As, Fougera Pharms Inc, Glenmark Pharms Ltd, and Veloxis Pharms Inc, and is included in eighteen NDAs. There are seventeen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tacrolimus has sixty-six patent family members in twenty-four countries.

There are twenty drug master file entries for tacrolimus. Twenty-three suppliers are listed for this compound.

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
Veloxis PharmaceuticalsEarly Phase 1
Vanderbilt University Medical CenterEarly Phase 1
Peking UniversityN/A

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
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Accord Hlthcare TACROLIMUS tacrolimus CAPSULE;ORAL 091195-002 Aug 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
McKesson
Merck
Harvard Business School
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.