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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Fuji
Accenture
Medtronic
Citi
Julphar
Cipla
Argus Health
US Army
Teva

Generated: February 21, 2018

DrugPatentWatch Database Preview

FOLOTYN Drug Profile

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When do Folotyn patents expire, and what generic alternatives are available?

Folotyn is a drug marketed by Allos and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in twenty-one countries.

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pralatrexate profile page.
Summary for FOLOTYN
Drug patent expirations by year for FOLOTYN
Pharmacology for FOLOTYN

US Patents and Regulatory Information for FOLOTYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes 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

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Paragraph IV (Patent) Challenges for FOLOTYN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 20 mg/mL and 40 mg/2 mL ➤ Subscribe 9/24/2013

Non-Orange Book US Patents for FOLOTYN

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
6,323,205 Combinations of 10-propargyl-10-deazaaminopterin and taxols and methods of using same in the treatment of tumors ➤ Sign Up
8,263,354 Methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin ➤ Sign Up
7,939,530 Treatment of lymphoma using 10-propargyl-10-deazaaminopterin and gemcitabine ➤ Sign Up
8,168,404 Methods to treat cancer with 10-propargyl-10-deazaaminopterin and methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for FOLOTYN

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Queensland Health
Accenture
Deloitte
Express Scripts
Daiichi Sankyo
Federal Trade Commission
US Department of Justice
AstraZeneca

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.

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