OFORTA Drug Patent Profile
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Which patents cover Oforta, and what generic alternatives are available?
Oforta is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in OFORTA 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 Oforta
A generic version of OFORTA was approved as fludarabine phosphate by HIKMA on August 28th, 2003.
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Summary for OFORTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 19 |
| Patent Applications: | 3,705 |
| DailyMed Link: | OFORTA at DailyMed |
Recent Clinical Trials for OFORTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hideho Okada, MD, PhD | Phase 1 |
| California Institute for Regenerative Medicine (CIRM) | Phase 1 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1 |
US Patents and Regulatory Information for OFORTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | 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 OFORTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OFORTA
See the table below for patents covering OFORTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 296366 | Zpusob výroby lithných, sodných, draselných, vápenatých a horecnatých solí fludarabin-fosfátu a zpusob cistení k výrobe fludarabin-fosfátu a fludarabin-fosfát s cistotou nejméne 99,5 % (Process for preparing fludarabine phosphate lithium, sodium, potassium, calcium and magnesium salts and purification method for producing fludarabine phosphate and fludarabine phosphate with at least 99.5 percent purity) | ⤷ Sign Up |
| Hong Kong | 1033831 | ⤷ Sign Up | |
| Mexico | PA04006005 | FORMULACION ORAL DE FLUDARA PURISIMO CON LIBERACION RAPIDA DEL INGREDIENTE ACTIVO. (ULTRAPURE ORAL FLUDARA FORMULATION WITH A FAST RELEASING ACTIVE SUBSTANCE.) | ⤷ Sign Up |
| Hong Kong | 1077741 | ⤷ Sign Up | |
| Poland | 195712 | ⤷ Sign Up | |
| Hungary | 226997 | METHOD FOR PRODUCING LITHIUM, SODIUM, POTASSIUM, CALCIUM AND MAGNESIUM SALTS OF FLUDARABIN PHOSPHATE PURIFICATION METHOD FOR PRODUCING FLUDARABIN PHOSPHATE AND FLUDARABIN PHOSPHATE WHICH IS AT LEAST 99,5% PURE | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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