Accord Company Profile

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

ACCORD has one hundred and fifty-five approved drugs.

There are four US patents protecting ACCORD drugs. There are three tentative approvals on ACCORD drugs.

There are thirty-five patent family members on ACCORD drugs in eighteen countries and three hundred and eighty-seven supplementary protection certificates in eighteen countries.

Summary for Accord

International Patents:	35
US Patents:	4
Tradenames:	132
Ingredients:	129
NDAs:	155
Patent Litigation for Accord:	See patent lawsuits for Accord
PTAB Cases with Accord as petitioner:	See PTAB cases with Accord as petitioner

Drugs and US Patents for Accord

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	202553-003	Apr 29, 2013	AB	RX	No	No
Accord Hlthcare	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	206251-006	Dec 7, 2016	AB	RX	No	No
Accord Hlthcare	CAPECITABINE	capecitabine	TABLET;ORAL	202593-002	Apr 23, 2015	AB	RX	No	No
Accord Hlthcare	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	202446-003	Jun 4, 2014	AB	RX	No	No
Accord Hlthcare	SIMVASTATIN	simvastatin	TABLET;ORAL	078155-005	Apr 5, 2013	AB	RX	No	No
Accord Hlthcare	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	214347-001	Nov 22, 2021		DISCN	No	No
Accord Hlthcare Inc	BUSULFAN	busulfan	INJECTABLE;INJECTION	210148-001	Feb 22, 2019	AP	RX	No	No

Paragraph IV (Patent) Challenges for ACCORD drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	200 mcg/vial		2015-05-01
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14

International Patents for Accord Drugs

Country	Patent Number	Estimated Expiration
Japan	2009523798
South Korea	101728868
European Patent Office	3727421
Japan	7223021
Taiwan	200831131
South Korea	20210005542
European Patent Office	1984009

Supplementary Protection Certificates for Accord Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	SPC/GB11/045	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1381356	14C0010	France		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1667986	2013/021	Ireland		PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1427415	PA2011012,C1427415	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
0219829	SPC/GB06/034	United Kingdom		PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
2785706	122020000046	Germany		PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316

Similar Applicant Names

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

• Accord
• Accord Hlthcare
• Accord Hlthcare Inc