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-three 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.
Summary for PROGRAF
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 399 |
Patent Applications: | 6,283 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PROGRAF |
What excipients (inactive ingredients) are in PROGRAF? | PROGRAF excipients list |
DailyMed Link: | PROGRAF at DailyMed |



Recent Clinical Trials for PROGRAF
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Health Network, Toronto | Phase 4 |
NYU Langone Health | Phase 2 |
Johns Hopkins University | Phase 3 |
Pharmacology for PROGRAF
Drug Class | Calcineurin Inhibitor Immunosuppressant |
Mechanism of Action | Calcineurin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ||||
>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 PROGRAF
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astellas | PROGRAF | tacrolimus | INJECTABLE;INJECTION | 050709-001 | Apr 8, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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 | ⤷ Try a Trial |
China | 1028961 | ⤷ Try a Trial | |
Ireland | 910679 | ⤷ Try a Trial | |
South Africa | 9101502 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |