ENDO OPERATIONS Company Profile

What is the competitive landscape for ENDO OPERATIONS, and when can generic versions of ENDO OPERATIONS drugs launch?

ENDO OPERATIONS has two hundred and twenty-one approved drugs.

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

There are one hundred and nineteen patent family members on ENDO OPERATIONS drugs in forty countries and three hundred and fifty-three supplementary protection certificates in seventeen countries.

Summary for ENDO OPERATIONS

International Patents:	119
US Patents:	41
Tradenames:	176
Ingredients:	155
NDAs:	221

Drugs and US Patents for ENDO OPERATIONS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-002	Apr 21, 2023		RX	Yes	Yes	11,083,698
Endo Operations	DOXYCYCLINE HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	216690-001	Dec 7, 2022		DISCN	No	No
Endo Operations	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-003	Apr 15, 2020		RX	Yes	Yes	9,919,026		Y
Endo Operations	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	040218-001	Sep 11, 1997		DISCN	No	No
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No	8,287,489		Y
Endo Operations	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071422-002	Nov 9, 1987		DISCN	No	No
Endo Operations	IBUPROFEN	ibuprofen	TABLET;ORAL	071232-001	Oct 22, 1986		DISCN	No	No

Expired US Patents for ENDO OPERATIONS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	7,276,250
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-006	Feb 29, 2008	7,276,250
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006	7,276,250
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-002	Jun 22, 2006	5,128,143
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	5,958,456
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	7,935,690
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008	7,276,250

Paragraph IV (Patent) Challenges for ENDO OPERATIONS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for ENDO OPERATIONS Drugs

Country	Patent Number	Estimated Expiration
Poland	1457208
World Intellectual Property Organization (WIPO)	2006009801
Japan	4865990
Australia	2006262144
Eurasian Patent Organization	200501819
Canada	2508301
Japan	5695296

Supplementary Protection Certificates for ENDO OPERATIONS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1044189	SPC/GB08/034	United Kingdom		PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928
0663916	14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN); NAT. REGISTRATION NO/DATE: 1-25271;1-25272; 1-25275,1-25276. 20040302; FIRST REGISTRATION: SE 18690;18691;18692; 18693;18694;18695. 20030718
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
0300652	2003C/005	Belgium		PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903

Similar Applicant Names

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

• Endo Operations
• Endo Pharms