FLUDARABINE Drug Patent Profile
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Which patents cover Fludarabine, and when can generic versions of Fludarabine launch?
Fludarabine is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Caplin One Labs, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Rising, and Sagent Pharms Inc. and is included in eleven NDAs.
The generic ingredient in FLUDARABINE is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fludarabine
A generic version of FLUDARABINE was approved as fludarabine phosphate by HIKMA on August 28th, 2003.
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Summary for FLUDARABINE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 11 |
| Drug Prices: | Drug price information for FLUDARABINE |
| DailyMed Link: | FLUDARABINE at DailyMed |
US Patents and Regulatory Information for FLUDARABINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Llc | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 203738-001 | Feb 28, 2017 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 078544-001 | Oct 15, 2007 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Caplin One Labs | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 022137-001 | Sep 21, 2007 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 076349-001 | Aug 28, 2003 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Actavis Totowa | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 078610-001 | Feb 11, 2009 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Areva Pharms | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 090724-001 | Sep 27, 2010 | AP1 | RX | No | No | ⤷ 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 |
