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PROGRAF Drug Profile
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See Plans and PricingWhich patents cover Prograf, and when can generic versions of Prograf launch?
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-three 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: | 63 |
| Clinical Trials: | 194 |
| Patent Applications: | 8,031 |
| 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 |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Phase 3 |
| University of Michigan Rogel Cancer Center | Phase 3 |
| Indiana University School of Medicine | Phase 3 |
Pharmacology for PROGRAF
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors |
Synonyms for PROGRAF
| (-)-FK 506 |
| [(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-14,16- |
| 104987-11-3 |
| 109581-93-3 (Hydrate) |
| 15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(23H)-tetrone, |
| 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyc |
| 4,5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-heptadecahydro-5,19-dihydroxy-3- |
| 581T933 |
| 8-DEETHYL-8-[BUT-3-ENYL]-ASCOMYCIN |
| AB0012538 |
| AB01209746_03 |
| AB01209746-01 |
| ABP000474 |
| AC-1182 |
| AC1L9IBU |
| Advagraf |
| AKOS005145901 |
| AM81227 |
| Anhydrous Tacrolimus |
| Astagraf XL |
| AT-2441 |
| Avagraf |
| BC205151 |
| BDBM50030448 |
| BDBM50079777 |
| BRD-K35452788-001-02-1 |
| BRD-K69608737-001-03-7 |
| BRD-K69608737-001-10-2 |
| BSPBio_001279 |
| C01375 |
| C44H69NO12 |
| CAS-104987-11-3 |
| CCRIS 7124 |
| CHEBI:61049 |
| CHEBI:93221 |
| CHEMBL269732 |
| CHEMBL66247 |
| CS-1507 |
| D08556 |
| DB00864 |
| dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-,(3S,4R,5S,8R,12S,14S,15R,16S,18R,19R,26aS)- |
| DSSTox_CID_26354 |
| DSSTox_GSID_46354 |
| DSSTox_RID_81557 |
| DTXSID5046354 |
| EN300-221601 |
| Envarsus |
| Envarsus XR |
| EX-A1677 |
| FK 506 |
| Fk-506 |
| FK-506 (Tacrolimus) |
| FK-506/Tacrolimus |
| FK5 |
| FK506 |
| FR 900506 |
| FR-900506 |
| FR900506 |
| FT-0082660 |
| Fujimycin |
| Fujimycin|||FK-506|||FR-900506 |
| Graceptor |
| GTPL6784 |
| Hecoria |
| HMS1792O21 |
| HMS1990O21 |
| HMS2093M19 |
| HMS3403O21 |
| HMS503O21 |
| HSDB 8195 |
| HY-13756 |
| IDI1_001040 |
| K506 |
| L 679934 |
| L-679934 |
| LCP-Tacro |
| LMPK04000003 |
| lohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-, (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)- |
| M2258 |
| MFCD11045918 |
| Modigraf |
| MolPort-003-666-518 |
| NCGC00163470-01 |
| NCGC00163470-02 |
| NCGC00163470-03 |
| NCGC00163470-04 |
| NCGC00163470-05 |
| NCGC00163470-06 |
| NCGC00163470-07 |
| NSC-758659 |
| NSC758659 |
| Pharmakon1600-01503968 |
| Prograf (TN) |
| Prograft |
| Protopic |
| Protopy |
| PubChem18875 |
| Q-201775 |
| QJJXYPPXXYFBGM-LFZNUXCKSA-N |
| s5003 |
| SBI-0052894.P002 |
| SC-13591 |
| SCHEMBL3088 |
| SR-05000001879 |
| SR-05000001879-1 |
| SR-05000001879-2 |
| SR-05000001879-5 |
| Tacarolimus |
| tacrolimus |
| Tacrolimus (anhydrous) |
| tacrolimus (fk506) |
| Tacrolimus (INN) |
| Tacrolimus [USAN:INN] |
| Tacrolimus [USAN] |
| Tacrolimus anhydrous |
| Tacrolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Tacrolimus, anhydrous |
| Talymus |
| Tox21_112056 |
| Tsukubaenolide |
| UNII-Y5L2157C4J |
| W-1246 |
| Y5L2157C4J |
| ZINC169289411 |
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 | |||
| >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 |
