ENDO Company Profile

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

ENDO has two hundred and thirty-one approved drugs.

There are forty-four US patents protecting ENDO drugs. There is one tentative approval on ENDO drugs.

There are two hundred and seventy-seven patent family members on ENDO drugs in forty-two countries and three hundred and fifty-three supplementary protection certificates in seventeen countries.

Summary for ENDO

International Patents:	277
US Patents:	44
Tradenames:	182
Ingredients:	158
NDAs:	231
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 Operations	DARIFENACIN HYDROBROMIDE	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	091190-001	Mar 13, 2015		DISCN	No	No
Endo Operations	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071422-005	Nov 9, 1987		DISCN	No	No
Endo Operations	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	078442-001	Oct 15, 2007		DISCN	No	No
Endo Operations	IBUPROFEN	ibuprofen	TABLET;ORAL	071232-001	Oct 22, 1986		DISCN	No	No

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	5,662,933
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	7,608,605
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,827,871
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-001	Dec 9, 2011	8,075,872

Paragraph IV (Patent) Challenges for ENDO drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	5 mg, 10 mg, 20 mg and 40 mg		2007-11-23
	Extended-release Tablets	30 mg		2008-06-12
	Gel	10 mg/actuation		2012-08-14
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Injection	250 mg/mL		2014-06-11
	for Injection	200 mcg/vial		2015-05-01
	Injection	20 units/mL, 1 mL		2018-03-23
	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
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	1 mg/mL ampules		2016-03-09

International Patents for ENDO Drugs

Country	Patent Number	Estimated Expiration
Croatia	P20070272
Norway	20080403
European Patent Office	1859789
Japan	2006520377

Supplementary Protection Certificates for ENDO Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114

Similar Applicant Names

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

• Endo Operations
• Endo Pharms