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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
US Department of Justice
Colorcon
Dow
Fuji
Chinese Patent Office
Teva
Citi
McKinsey

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022468

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NDA 022468 describes FOLOTYN, which is a drug marketed by Allos and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FOLOTYN profile page.

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 022468
Tradename:FOLOTYN
Applicant:Allos
Ingredient:pralatrexate
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 022468
Suppliers and Packaging for NDA: 022468
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468 NDA Allos Therapeutics 48818-001 48818-001-01 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) > 1 mL in 1 VIAL, SINGLE-USE
FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468 NDA Allos Therapeutics 48818-001 48818-001-02 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-02) > 2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/ML (20MG/ML)
Approval Date:Sep 24, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 24, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:➤ SubscribePatent Expiration:Jul 16, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
Patent:➤ SubscribePatent Expiration:May 31, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

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Serving leading biopharmaceutical companies globally:

Cerilliant
Harvard Business School
US Army
Teva
UBS
Chubb
McKinsey
Farmers Insurance
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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