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, Rising, 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.
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Questions you can ask:
- What is the 5 year forecast for FLUDARA?
- What are the global sales for FLUDARA?
- What is Average Wholesale Price for FLUDARA?
Summary for FLUDARA
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 513 |
| Patent Applications: | 5,640 |
| 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 |
|---|---|
| Fred Hutchinson Cancer Center | Phase 2 |
| National Cord Blood Network | Phase 2 |
| James Isaacs, MD | Phase 1 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 076349-001 | Aug 28, 2003 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Areva Pharms | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 090724-001 | Sep 27, 2010 | AP1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 022137-001 | Sep 21, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | FLUDARABINE PHOSPHATE | fludarabine phosphate | INJECTABLE;INJECTION | 077790-001 | Apr 6, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
