FLUDARABINE PHOSPHATE Drug Patent Profile
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Which patents cover Fludarabine Phosphate, and what generic alternatives are available?
Fludarabine Phosphate is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Rising, Sagent Pharms Inc, and Sandoz. and is included in eleven NDAs.
The generic ingredient in FLUDARABINE PHOSPHATE 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 Phosphate
A generic version of FLUDARABINE PHOSPHATE was approved as fludarabine phosphate by HIKMA on August 28th, 2003.
Summary for FLUDARABINE PHOSPHATE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 478 |
| Patent Applications: | 2,293 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FLUDARABINE PHOSPHATE at DailyMed |
Recent Clinical Trials for FLUDARABINE PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| James Michael Martin | Phase 1 |
| Invectys | Phase 1/Phase 2 |
| Dana-Farber Cancer Institute | Phase 2 |
Pharmacology for FLUDARABINE PHOSPHATE
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for FLUDARABINE PHOSPHATE
US Patents and Regulatory Information for FLUDARABINE PHOSPHATE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hospira | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 077790-001 | Apr 6, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 078393-001 | Oct 15, 2007 | AP1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Labs Ltd | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 200647-001 | Dec 21, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Actavis Totowa | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 078610-001 | Feb 11, 2009 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
