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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Fish and Richardson
Deloitte
Cerilliant
Mallinckrodt
Healthtrust
Colorcon
Argus Health

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202317

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NDA 202317 describes VALCHLOR, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the VALCHLOR profile page.

The generic ingredient in VALCHLOR is mechlorethamine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.
Summary for 202317
Tradename:VALCHLOR
Applicant:Actelion Pharms Ltd
Ingredient:mechlorethamine hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 202317
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 202317
Suppliers and Packaging for NDA: 202317
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317 NDA Actelion Pharmaceuticals US, Inc. 66215-001 E 66215-001-05
VALCHLOR mechlorethamine hydrochloride GEL;TOPICAL 202317 NDA Actelion Pharmaceuticals US, Inc. 66215-016 N 66215-016-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 0.016% BASE
Approval Date:Aug 23, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 23, 2020
Regulatory Exclusivity Use:TOPICAL TREATMENT OF STAGE 1A AND 1B MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN-DIRECTED THERAPY
Patent:➤ Sign UpPatent Expiration:Mar 7, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 8, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN DIRECTED THERAPY

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Mallinckrodt
Johnson and Johnson
Harvard Business School
Accenture
Cerilliant
Cipla
Daiichi Sankyo
Deloitte

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