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Pralatrexate - Generic Drug Details

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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.

This ingredient has thirty-eight 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.

Summary for Generic Name: pralatrexate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: pralatrexate

Tentative approvals for PRALATREXATE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION20MG/1ML
<disabled><disabled>INJECTABLE;INJECTION40MG/2ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allos
FOLOTYN
pralatrexate
SOLUTION;INTRAVENOUS022468-002Sep 24, 2009RXYes8,299,078► subscribe ► subscribe
Allos
FOLOTYN
pralatrexate
SOLUTION;INTRAVENOUS022468-001Sep 24, 2009RXNo6,028,071► subscribeYY ► subscribe
Allos
FOLOTYN
pralatrexate
SOLUTION;INTRAVENOUS022468-002Sep 24, 2009RXYes6,028,071► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,263,354Methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin► subscribe
6,323,205 Combinations of 10-propargyl-10-deazaaminopterin and taxols and methods of using same in the treatment of tumors► subscribe
7,939,530Treatment of lymphoma using 10-propargyl-10-deazaaminopterin and gemcitabine► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: pralatrexate

Country Document Number Estimated Expiration
Norway20065971► subscribe
Germany602005009176► subscribe
Portugal1750716► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 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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