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AMPYRA

NDA

DALFAMPRIDINE | N022250 | MERZ PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Acorda Therapeutics Inc. et al v. Actavis Laboratories FL, Inc. 1:2015cv00077 1 patentANDA 206836dalfampridine	D. Del.	2015-01-23	Terminated 2015-10-21	—
Acorda Therapeutics Inc. et al v. Teva Pharmaceuticals USA Inc. 1:2014cv00941 5 patentsANDA 206854dalfampridine	D. Del.	2014-07-17	Terminated 2017-04-25	—
Acorda Therapeutics Inc. et al v. Accord Healthcare Inc. 1:2014cv00932 5 patentsANDA 206863dalfampridine	D. Del.	2014-07-15	Terminated 2016-08-18	—
Acorda Therapeutics Inc. et al v. Alkem Laboratories Ltd. 1:2014cv00917 5 patentsANDA 206765dalfampridine	D. Del.	2014-07-11	Terminated 2016-08-05	—
Acorda Therapeutics Inc. et al v. Aurobindo Pharma Ltd. et al 1:2014cv00909 5 patentsANDA 206811dalfampridine	D. Del.	2014-07-10	Terminated 2015-12-15	—
Acorda Therapeutics Inc. et al. v. Alkem Laboratories Ltd. et al. 1:2014cv00882 4 patentsANDA 206836dalfampridine	D. Del.	2014-07-07	Terminated 2017-04-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Acorda Therapeutics, Inc FDA-2016-P-4585 Acorda Therapeutics, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA carefully review any abbreviated new drug application referencing AMPYRA (dalfampridine) Extended Release Tablets to ensure adequate identification and quali	505(q)	2016-12-28	Open	Acorda Therapeutics
Citizen Petition From Acorda Therapeutics FDA-2014-P-2193 Acorda Therapeutics filed this petition on December 12, 2014 requesting that the FDA establish more stringent bioequivalence criteria for abbreviated new drug applications under section 505(j) for generic versions of dalfampridine citing Acorda's Ampyra as the reference listed drug, including requir	505(q)	2014-12-15	Denied	Acorda Therapeutics

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Exploration of the Association Between White Matter Lesion Burden and Dalfampridine Response in Insidious-Onset Vascular Parkinsonism NCT07682428	—	Completed	Tang-Du Hospital	72	2023-08-01 → 2025-01-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Ampyra (2023)

Total Spending

$44.4M

Total Claims

7,905

Beneficiaries

1,179

Avg Cost/Unit

$67.88

Spending Trend

$102.2M(2019)→$72.1M(2020)→$55.9M(2021)→$48.6M(2022)→$44.4M(2023)

YoY Change:+10.9%

5yr CAGR:+9.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs1 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

CU CHEMIE UETIKON GMBHDALFAMPRIDINE

DMF 178602004

JUBILANT PHARMOVA LTDDALFAMPRIDINE USP

DMF 247182011

INDUSTRIALE CHIMICA SRLDALFAMPRIDINE

DMF 276232013

ALKEM LABORATORIES LTDDALFAMPRIDINE USP

DMF 276372013

PROCOS SPADALFAMPRIDINE

DMF 276472013

SUN PHARMACEUTICAL INDUSTRIES LTDDALFAMPRIDINE USP

DMF 276622013

INTAS PHARMACEUTICALS LTDDALFAMPRIDINE

DMF 278192013

APITORIA PHARMA PRIVATE LTDDALFAMPRIDINE

DMF 278432014

MICRO LABS LTDDALFAMPRIDINE USP

DMF 331462018

SHANDONG NEW TIME PHARMACEUTICAL CO LTDDALFAMPRIDINE

DMF 420752025

ENALTEC LABS PRIVATE LTDInactiveDALFAMPRIDINE

DMF 256952012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2021	SUPPL -19	View Letter (PDF)
Feb 25, 2021	SUPPL -18	View Letter (PDF)
Dec 23, 2019	SUPPL -17	View Letter (PDF)
Oct 3, 2017	SUPPL -15	View Letter (PDF)
Oct 3, 2017	SUPPL -15	View Letter (PDF)
Oct 17, 2016	SUPPL -13	View Letter (PDF)
Jun 20, 2013	SUPPL -8	View Letter (PDF)
Jan 24, 2013	SUPPL -6	View Letter (PDF)
Dec 26, 2012	SUPPL -7	View Letter (PDF)
Jul 24, 2012	SUPPL -4	View Letter (PDF)
Nov 21, 2011	SUPPL -2	View Letter (PDF)
Jan 29, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 22, 2010

No patent or exclusivity listings for this strength.