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Last Updated: May 28, 2022

PROGRAF Drug Patent 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. Thirty-one suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

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
Johns Hopkins UniversityPhase 3
HK inno.N CorporationPhase 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2

See all PROGRAF clinical trials

Pharmacology for PROGRAF

US Patents and Regulatory Information for PROGRAF

PROGRAF is protected by zero US patents and three FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting PROGRAF

FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT
Exclusivity Expiration: See Plans and Pricing

PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: See Plans and Pricing

PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY TRANSPLANT, LIVER TRANSPLANTS, AND HEART TRANSPLANT, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: See Plans and Pricing

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

International Patents for PROGRAF

See the table below for patents covering PROGRAF around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 62797 A pharmaceutical solution comprising derivatives of FK506 See Plans and Pricing
China 1028961 See Plans and Pricing
Ireland 910679 See Plans and Pricing
South Africa 9101502 See Plans and Pricing
Greece 3021777 See Plans and Pricing
Hungary 209436 PROCESS FOR PRODUCING PHARMACEUTICAL SOLUTIONS CONTAINING MACROLIDES See Plans and Pricing
Germany 69122418 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Moodys
McKesson
Dow

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.