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Last Updated: February 27, 2021

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PROGRAF Drug Profile

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

Prograf is a drug marketed by Astellas and is included in three NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Prograf

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

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Drug patent expirations by year for PROGRAF
Drug Prices for PROGRAF

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Drug Sales Revenue Trends for PROGRAF

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Recent Clinical Trials for PROGRAF

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

SponsorPhase
BioPharma Services USAPhase 1
Food and Drug Administration (FDA)Phase 1
M.D. Anderson Cancer CenterPhase 1

See all PROGRAF clinical trials

Pharmacology for PROGRAF

US Patents and Regulatory Information for PROGRAF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-003 Aug 24, 1998 AB RX Yes 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
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-001 Apr 8, 1994 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-002 Apr 8, 1994 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus FOR SUSPENSION;ORAL 210115-002 May 24, 2018 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

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McKesson
Dow

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