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Last Updated: November 28, 2021

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TACROLIMUS - Generic Drug Details

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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, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Heritage Pharma, Mylan, Panacea, Sandoz, Strides Pharma, Hospira Inc, Leo Pharma As, Fougera Pharms Inc, and Veloxis Pharms Inc, and is included in twenty-two NDAs. There are twenty 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. Thirty suppliers are listed for this compound.

Drug Prices for TACROLIMUS

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Drug Sales Revenue Trends for TACROLIMUS

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Recent Clinical Trials for TACROLIMUS

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SponsorPhase
University College, LondonPhase 1/Phase 2
Natera, Inc.Phase 1/Phase 2
Milton S. Hershey Medical CenterPhase 1/Phase 2

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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
Mylan TACROLIMUS tacrolimus CAPSULE;ORAL 090596-001 Sep 17, 2010 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-003 Aug 24, 1998 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  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

Expired US Patents for TACROLIMUS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TACROLIMUS

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2008145143 ⤷  Free Forever Trial
Canada 2729948 ⤷  Free Forever Trial
Lithuania 2575769 ⤷  Free Forever Trial
Eurasian Patent Organization 201390412 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2005020994 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Express Scripts
Colorcon
Merck

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