Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Mallinckrodt
Merck
Cantor Fitzgerald
Argus Health
QuintilesIMS
US Department of Justice
Dow
Cerilliant

Generated: February 25, 2018

DrugPatentWatch Database Preview

Fludarabine phosphate - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for fludarabine phosphate and what is the scope of fludarabine phosphate patent protection?

Fludarabine phosphate
is the generic ingredient in three branded drugs marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mustafa Nevzat Ilac, Mylan Labs Ltd, Sagent Pharms, Sandoz, and Sanofi Aventis Us, and is included in thirteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fludarabine phosphate has sixty-nine patent family members in thirty-four countries.

There are ten drug master file entries for fludarabine phosphate. Eight suppliers are listed for this compound.
Summary for fludarabine phosphate
Pharmacology 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
Sagent Pharms FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 076661-001 Apr 28, 2004 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mustafa Nevzat Ilac FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 090724-001 Sep 27, 2010 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 022137-001 Sep 21, 2007 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us OFORTA fludarabine phosphate TABLET;ORAL 022273-001 Dec 18, 2008 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fresenius Kabi Usa FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078544-001 Oct 15, 2007 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Totowa FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078610-001 Feb 11, 2009 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Custopharm Inc FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 076349-001 Aug 28, 2003 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 200647-001 Dec 21, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Llc FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 203738-001 Feb 28, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 077790-001 Apr 6, 2007 AP RX No Yes ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for fludarabine phosphate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,046,322 Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5% ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for fludarabine phosphate

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cerilliant
UBS
Julphar
Dow
Cantor Fitzgerald
Farmers Insurance
Chubb
Covington

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 verifification 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.

botpot