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Last Updated: August 11, 2020

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TACROLIMUS - Generic Drug Details

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What are the generic 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 sixteen 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-four 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 of Maryland, BaltimorePhase 2
Peking Union Medical College HospitalPhase 2
NYU Langone HealthN/A

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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
Dr Reddys Labs Ltd TACROLIMUS tacrolimus CAPSULE;ORAL 090509-001 May 12, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Accord Hlthcare TACROLIMUS tacrolimus CAPSULE;ORAL 091195-003 Aug 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus FOR SUSPENSION;ORAL 210115-001 May 24, 2018 RX Yes 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

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 204096-002 Jul 19, 2013   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000   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

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