ENDO Company Profile

What is the competitive landscape for ENDO

ENDO has thirty-five approved drugs.

There are nine US patents protecting ENDO drugs.

There are two hundred and thirty-four patent family members on ENDO drugs in forty-two countries and three supplementary protection certificates in three countries.

Summary for ENDO

International Patents:	234
US Patents:	9
Tradenames:	30
Ingredients:	24
NDAs:	35
Patent Litigation for ENDO:	See patent lawsuits for ENDO
PTAB Cases with ENDO as petitioner:	See PTAB cases with ENDO as petitioner
PTAB Cases with ENDO as patent owner:	See PTAB cases with ENDO as patent owner

Drugs and US Patents for ENDO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Pharms	DELATESTRYL	testosterone enanthate	INJECTABLE;INJECTION	009165-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Endo Operations	ROBAXIN-750	methocarbamol	TABLET;ORAL	011011-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007		RX	Yes	Yes	8,062,652
Endo Operations	PERCODAN-DEMI	aspirin; oxycodone hydrochloride; oxycodone terephthalate	TABLET;ORAL	007337-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-001	Dec 9, 2011		DISCN	Yes	No	7,851,482			Y

Expired US Patents for ENDO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008	5,128,143
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008	8,329,216
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	3,415,821
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011	8,192,722
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-002	Jun 22, 2006	7,276,250
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	7,320,968

Paragraph IV (Patent) Challenges for ENDO drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Gel	10 mg/actuation		2012-08-14
	Injection	250 mg/mL		2014-06-11
	Extended-release Tablets	7.5 mg and 15 mg		2008-05-29
	Tablets	2.5 mg		2011-03-09
	Nasal Spray	500 mcg/spray		2017-04-28
	Gel	1%		2008-08-21
	Extended-release Tablets	5 mg, 10 mg, 20 mg and 40 mg		2007-11-23
	Extended-release Tablets	30 mg		2008-06-12

International Patents for ENDO Drugs

Country	Patent Number	Estimated Expiration
Poland	2478896
South Africa	200508313
World Intellectual Property Organization (WIPO)	2004080383
China	1863513
Austria	517610
Japan	5695296

Supplementary Protection Certificates for ENDO Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591280	SPC/GB03/014	United Kingdom		PRODUCT NAME: 3 METHYLAMINO-6-CARBOXAMIDO-1, 2, 3, 4-TETRAHYDROCARBAZOLE ("FROVATRIPTAN") INCLUDING A SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: FR NL 24548 20001212; UK PL 16239/0017 20021007; UK PL 16239/0018 20021007
0591280	01C0019	France		PRODUCT NAME: FROVATRIPTAN SUCCINATE MONOHYDRATE; NAT. REGISTRATION NO/DATE: NL 24548 20001212; FIRST REGISTRATION: FR - NL 24548 20001212
0591280	C300103	Netherlands		PRODUCT NAME: FROVATRIPTAN EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 27211RVG 27212 2002190419; FIRST REGISTRATION: NL 24548 20001212

Similar Applicant Names

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

• Endo Operations
• Endo Pharms