FLUDARA Drug Patent Profile
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Which patents cover Fludara, and what generic alternatives are available?
Fludara is a drug marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent Pharms Inc, and Sandoz. and is included in twelve NDAs.
The generic ingredient in FLUDARA 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 Fludara
A generic version of FLUDARA was approved as fludarabine phosphate by HIKMA on August 28th, 2003.
Summary for FLUDARA
US Patents: | 0 |
Applicants: | 10 |
NDAs: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 505 |
Patent Applications: | 4,910 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FLUDARA |
DailyMed Link: | FLUDARA at DailyMed |
Recent Clinical Trials for FLUDARA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | Phase 1 |
Center for International Blood and Marrow Transplant Research | Phase 1/Phase 2 |
Eugia Pharma Specialities Limited | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for FLUDARA
US Patents and Regulatory Information for FLUDARA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 076349-001 | Aug 28, 2003 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Areva Pharms | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 090724-001 | Sep 27, 2010 | AP1 | RX | No | No | ⤷ 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 |
Expired US Patents for FLUDARA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genzyme Corp | FLUDARA | fludarabine phosphate | INJECTABLE;INJECTION | 020038-001 | Apr 18, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |