AMPYRA Drug Patent Profile

Which patents cover Ampyra, and when can generic versions of Ampyra launch?

Ampyra is a drug marketed by Merz Pharms and is included in one NDA.

The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ampyra

A generic version of AMPYRA was approved as dalfampridine by ACTAVIS LABS FL INC on January 23^rd, 2017.

Summary for AMPYRA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	21
Patent Applications:	2,939
Drug Prices:	Drug price information for AMPYRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMPYRA
What excipients (inactive ingredients) are in AMPYRA?	AMPYRA excipients list
DailyMed Link:	AMPYRA at DailyMed

See drug prices for AMPYRA

Recent Clinical Trials for AMPYRA

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

Sponsor	Phase
MGH Institute of Health Professions	Phase 4
Milton S. Hershey Medical Center	Phase 2/Phase 3
Weill Medical College of Cornell University	Phase 1

See all AMPYRA clinical trials

Pharmacology for AMPYRA

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

Paragraph IV (Patent) Challenges for AMPYRA

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 AMPYRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merz Pharms	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes

Expired US Patents for AMPYRA

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	5,370,879
Merz Pharms	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	5,540,938
Merz Pharms	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	9,918,973

International Patents for AMPYRA

See the table below for patents covering AMPYRA around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	91933
Czechoslovakia	9103313
Spain	2406604
Slovenia	2377536
Spain	2141706
Montenegro	01721	POSTUPCI ZA PRIMJENU KOMPOZICIJA AMINOPIRIDINA SA PRODUŽENIM OSLOBAĐANJEM (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS)

Supplementary Protection Certificates for AMPYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0484186	1190033-9	Sweden		PRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720
2377536	PA2013015	Lithuania		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
2377536	13C0033	France		PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110725
2377536	C300612	Netherlands		PRODUCT NAME: 4-AMINOPYRIDINE, DAN WEL EEN DERIVAAT DAARVAN, IN HET BIJZONDER EEN ZOUT, SOLVAAT OF PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
0484186	91894	Luxembourg		91894, EXPIRES: 20161101
0484186	CA 2011 00031	Denmark

AMPYRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of AMPYRA

Introduction to AMPYRA

AMPYRA, also known as dalfampridine, is a medication developed by Acorda Therapeutics to improve walking in patients with multiple sclerosis (MS). It works by blocking potassium leakage from the degenerated myelin sheath, thereby increasing nerve signal conduction from the brain to other parts of the body[1].

Launch and Initial Success

AMPYRA was launched in March 2010 and quickly gained traction among neurologists and patients. By the end of the third quarter of 2010, the drug had seen a significant increase in prescriptions, with patient starts rising by 22% to 16,920, and almost 90% of high-prescribing specialists writing at least one AMPYRA prescription. Approximately 31,000 MS patients in the USA had tried the drug by then, representing about 8% of all MS patients in the country[1].

Peak Sales and Revenue

AMPYRA reached its peak in terms of sales and revenue in the years following its launch. In 2015, the drug generated $437 million in sales, accounting for 89% of Acorda's annual revenues. Sales continued to climb, with a nearly 15% year-over-year increase through the third quarter of 2016[4].

Challenges and Decline

However, several factors have contributed to the decline in AMPYRA's sales and revenue over the years.

Generic Competition

One of the most significant challenges was the loss of exclusivity in 2018, which allowed generic versions of the drug to enter the market. This led to a decline in AMPYRA's net revenue. For example, in the third quarter of 2023, AMPYRA net revenue was $15.7 million, a 26% decrease compared to the same quarter in 2022[2].

Failed Clinical Trials

Acorda's attempt to expand AMPYRA's indication to post-stroke walking difficulties failed in clinical trials. This failure impacted the drug's potential for additional revenue streams and further limited its growth prospects[4].

Patent Challenges

The drug has also faced patent challenges, including an inter partes review of a patent challenge, which has added uncertainty to its future revenue potential[4].

Financial Performance

Quarterly and Annual Revenue

In recent years, AMPYRA's revenue has continued to decline. For the quarter ended September 30, 2023, AMPYRA net revenue was $15.7 million, down from $21.1 million in the same quarter of 2022. For the full year 2021, AMPYRA net revenue was $84.6 million, and for the fourth quarter of 2021, it was $22.5 million[2][3].

Operating Expenses

Acorda has been working to manage its operating expenses in the face of declining revenue. The company reduced its operating expenses significantly, with a $60 million annualized reduction expected in 2022 compared to 2020. Research and development (R&D) expenses and sales, general, and administrative (SG&A) expenses have also been reduced over the years[3][5].

Diversification Efforts

To mitigate the impact of AMPYRA's declining revenue, Acorda has diversified its product portfolio. For instance, the company acquired Biote, a Finnish firm, adding two Parkinson's drugs to its pipeline. Additionally, Acorda has seen growth in its other product, INBRIJA (levodopa inhalation powder), with a 22% increase in net revenue in 2021 compared to 2020[3][4].

Global Sales and Partnerships

AMPYRA's sales are not limited to the U.S. market. Acorda has agreements to commercialize INBRIJA and FAMPYRA (the ex-U.S. version of AMPYRA) in other countries. For example, INBRIJA was launched in Spain in early 2023, and Acorda expects significant royalties from these international sales[3].

Future Outlook

Given the ongoing decline in AMPYRA's revenue due to generic competition and the failure to expand its indications, Acorda expects AMPYRA revenue to continue to decrease. However, the company is focusing on maintaining fiscal discipline and exploring new revenue streams through its diversified product portfolio and international partnerships[2][3].

Key Takeaways

• Initial Success: AMPYRA saw significant growth and adoption following its launch in 2010.
• Decline Due to Generics: The loss of exclusivity in 2018 led to a decline in revenue.
• Failed Clinical Trials: Attempts to expand indications to post-stroke walking difficulties were unsuccessful.
• Diversification: Acorda has diversified its portfolio to mitigate the impact of AMPYRA's decline.
• Global Sales: The company is leveraging international partnerships to generate additional revenue.
• Financial Management: Acorda is managing operating expenses to maintain fiscal stability.

FAQs

Q: What is AMPYRA used for? A: AMPYRA is used to improve walking in patients with multiple sclerosis (MS) by blocking potassium leakage from the degenerated myelin sheath.

Q: When was AMPYRA launched? A: AMPYRA was launched in March 2010.

Q: Why has AMPYRA's revenue declined? A: The revenue has declined due to the loss of exclusivity in 2018, allowing generic versions to enter the market, and the failure of clinical trials to expand its indications.

Q: How is Acorda managing the decline in AMPYRA revenue? A: Acorda is diversifying its product portfolio, reducing operating expenses, and leveraging international partnerships to generate new revenue streams.

Q: What other products does Acorda Therapeutics market? A: Besides AMPYRA, Acorda markets INBRIJA (levodopa inhalation powder) and has other products in its pipeline, including those acquired through the purchase of Biote.

Sources

1. CBS News - Acorda's MS Drug Ampyra Looks Good Now, but That Probably Won't Last
2. Business Wire - Acorda Therapeutics Reports Third Quarter 2023 Financial Results
3. Acorda Therapeutics - Reports Fourth Quarter and Full Year 2021 Financial Results
4. BioPharma Dive - Trial miss derails Acorda's Ampyra plans
5. Business Wire - Acorda Therapeutics Reports Third Quarter 2022 Financial Results