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PROGRAF Drug Profile
» See Plans and Pricing
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.
Summary for PROGRAF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 207 |
| Patent Applications: | 4,479 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROGRAF |
| Drug Sales Revenues: | Drug sales revenues for PROGRAF |
| DailyMed Link: | PROGRAF at DailyMed |
Recent Clinical Trials for PROGRAF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| BioPharma Services USA | Phase 1 |
| Food and Drug Administration (FDA) | Phase 1 |
| M.D. Anderson Cancer Center | Phase 1 |
Pharmacology for PROGRAF
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors |
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 |
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROGRAF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 62797 | Start Trial |
| Ireland | 75221 | Start Trial |
| Japan | H04211012 | Start Trial |
| South Africa | 9101502 | Start Trial |
| European Patent Office | 0444659 | Start Trial |
| China | 1055110 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
