DALFAMPRIDINE - Generic Drug Details

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

Dalfampridine is the generic ingredient in two branded drugs marketed by Merz Pharms, Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma, Hikma, Micro Labs, Rising, and Sun Pharm, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for dalfampridine. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DALFAMPRIDINE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	34
Patent Applications:	6,381
Drug Prices:	Drug price trends for DALFAMPRIDINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DALFAMPRIDINE
What excipients (inactive ingredients) are in DALFAMPRIDINE?	DALFAMPRIDINE excipients list
DailyMed Link:	DALFAMPRIDINE at DailyMed

See drug prices for DALFAMPRIDINE

Recent Clinical Trials for DALFAMPRIDINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
MGH Institute of Health Professions	Phase 4
European University of Lefke	N/A
Shirley Ryan AbilityLab	Early Phase 1

See all DALFAMPRIDINE clinical trials

Generic filers with tentative approvals for DALFAMPRIDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DALFAMPRIDINE

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

Paragraph IV (Patent) Challenges for DALFAMPRIDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMPYRA	Extended-release Tablets	dalfampridine	10 mg	022250	8	2014-01-22

US Patents and Regulatory Information for DALFAMPRIDINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206765-001	Jul 30, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	208292-001	May 21, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206646-001	Oct 24, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	DALFAMPRIDINE	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	206863-001	Jul 11, 2018	AB	RX	No	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

Expired US Patents for DALFAMPRIDINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz Pharms	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Sign Up	⤷ Sign Up
Merz Pharms	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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