Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206863

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NDA 206863 describes DALFAMPRIDINE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma Ltd, Micro Labs, Sun Pharm, and West-ward Pharms Int, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the DALFAMPRIDINE profile page.

The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
Summary for 206863
Applicant:Accord Hlthcare
Formulation / Manufacturing:see details
Pharmacology for NDA: 206863
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 206863
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863 ANDA Accord Healthcare Inc. 16729-292 16729-292-12 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16729-292-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jul 11, 2018TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 9, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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