Details for New Drug Application (NDA): 208114
NDA 208114 describes DEFITELIO, which is a drug marketed by Jazz Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DEFITELIO profile page.
The generic ingredient in DEFITELIO is defibrotide sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the defibrotide sodium profile page.
The generic ingredient in DEFITELIO is defibrotide sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the defibrotide sodium profile page.
Summary for 208114
| Tradename: | DEFITELIO |
| Applicant: | Jazz Pharms Inc |
| Ingredient: | defibrotide sodium |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208114
Generic Entry Date for 208114*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 208114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFITELIO | defibrotide sodium | SOLUTION;INTRAVENOUS | 208114 | NDA | Jazz Pharmaceuticals, Inc. | 68727-800 | 68727-800-01 | 2.5 mL in 1 VIAL (68727-800-01) |
| DEFITELIO | defibrotide sodium | SOLUTION;INTRAVENOUS | 208114 | NDA | Jazz Pharmaceuticals, Inc. | 68727-800 | 68727-800-02 | 25 mL in 1 CARTON (68727-800-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/2.5ML (80MG/ML) | ||||
| Approval Date: | Mar 30, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 11,085,043 | Patent Expiration: | Jun 22, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,236,328 | Patent Expiration: | Jun 22, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM-CELL TRANSPLANTATION (HSCT) | ||||||||
| Patent: | 11,746,348 | Patent Expiration: | Jun 22, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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