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Serving leading biopharmaceutical companies globally:

Cerilliant
Healthtrust
Queensland Health
Teva
Argus Health
Novartis
Dow
McKesson
Julphar
Cipla

Generated: February 19, 2018

DrugPatentWatch Database Preview

Pralatrexate - Generic Drug Details

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What are the generic sources for pralatrexate and what is the scope of pralatrexate freedom to operate?

Pralatrexate
is the generic ingredient in one branded drug marketed by Allos and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are two drug master file entries for pralatrexate. One supplier is listed for this compound. There is one tentative approval for this compound.
Pharmacology for pralatrexate
Tentative approvals for PRALATREXATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up20MG/1MLINJECTABLE;INJECTION
➤ Sign Up➤ Sign Up40MG/2MLINJECTABLE;INJECTION

US Patents and Regulatory Information for pralatrexate

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 ➤ Sign Up
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 022468-002 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
Allos FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 RX Yes 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

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Non-Orange Book US Patents for pralatrexate

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 pralatrexate

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Chubb
Baxter
McKinsey
Harvard Business School
Citi
Deloitte
Covington
Boehringer Ingelheim

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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