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.
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: | 66 |
Clinical Trials: | 395 |
Patent Applications: | 7,198 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PROGRAF |
Drug Sales Revenues: | Drug sales revenues 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 |
---|---|
Johns Hopkins University | Phase 3 |
HK inno.N Corporation | Phase 1 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
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: 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
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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |