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Last Updated: March 28, 2024

PROGRAF Drug Patent Profile


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When do Prograf patents expire, 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-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

DrugPatentWatch® 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

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SponsorPhase
University Health Network, TorontoPhase 4
NYU Langone HealthPhase 2
Johns Hopkins UniversityPhase 3

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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: ⤷  Try a Trial

PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: ⤷  Try a Trial

PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY TRANSPLANT, LIVER TRANSPLANTS, AND HEART TRANSPLANT, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
Exclusivity Expiration: ⤷  Try a Trial

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

EU/EMA Drug Approvals for PROGRAF

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Astellas Pharma Europe B.V. Modigraf tacrolimus EMEA/H/C/000954
Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Authorised no no no 2009-05-15
Astellas Pharma Europe BV Advagraf tacrolimus EMEA/H/C/000712
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Authorised no no no 2007-04-23
Chiesi Farmaceutici S.p.A. Envarsus tacrolimus EMEA/H/C/002655
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Authorised no no no 2014-07-18
LEO Pharma A/S Protopic tacrolimus EMEA/H/C/000374
Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Authorised no no no 2002-02-27
Teva B.V. Tacforius tacrolimus EMEA/H/C/004435
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Authorised yes no no 2017-12-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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