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Acorda Company Profile

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What is the competitive landscape for ACORDA, and what generic alternatives to ACORDA drugs are available?

ACORDA has two approved drugs.

There are seven US patents protecting ACORDA drugs.

There are fifty-eight patent family members on ACORDA drugs in twenty-three countries and twenty-three supplementary protection certificates in ten countries.

Summary for Acorda

International Patents:	58
US Patents:	7
Tradenames:	2
Ingredients:	2
NDAs:	2
Patent Litigation for Acorda:	See patent lawsuits for Acorda
PTAB Cases with Acorda as patent owner:	See PTAB cases with Acorda as patent owner

Drugs and US Patents for Acorda

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acorda	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes	8,663,685
Acorda	QUTENZA	capsaicin	PATCH;TOPICAL	022395-001	Nov 16, 2009		RX	Yes	Yes	6,239,180		Y
Acorda	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes	8,007,826
Acorda	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	AB	RX	Yes	Yes	8,354,437

Expired US Patents for Acorda

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acorda	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	5,370,879
Acorda	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010	5,540,938

Paragraph IV (Patent) Challenges for ACORDA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	10 mg		2014-01-22

Non-Orange Book US Patents for Acorda

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,370,879	Formulations and their use in the treatment of neurological diseases
6,248,788	Therapeutic method with capsaicin and capasicin analogs
5,580,580	Formulations and their use in the treatment of neurological diseases
9,925,173	Methods of using sustained release aminopyridine compositions

International Patents for Acorda Drugs

Country	Document Number	Estimated Expiration
Japan	5914626
Canada	2870734
Japan	H04273820
Slovenia	2377536

Supplementary Protection Certificates for Acorda Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012001	Lithuania		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
C0033	France		PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110725
90033-9	Sweden		PRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720
2013000046	Germany		PRODUCT NAME: 4-AMINOPYRIDIN ODER EIN DERIVAT DAVON, INSBESONDERE EIN SALZ, EIN SOLVAT ODER EINE PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Acorda