ENDO OPERATIONS Company Profile

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

There are forty-two 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.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes		⤷ Subscribe				⤷ Subscribe
Endo Operations	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	202964-001	May 2, 2016	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
Endo Operations	CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	209358-001	Nov 10, 2021	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Endo Operations	GLIPIZIDE	glipizide	TABLET, EXTENDED RELEASE;ORAL	076159-002	Sep 20, 2013		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Endo Operations	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075340-001	Feb 24, 1999	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
Endo Operations	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200491-003	Jun 27, 2012		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009	8,267,903	⤷ Subscribe
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	5,145,684	⤷ Subscribe
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008	8,309,112	⤷ Subscribe
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,229,636	⤷ Subscribe
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,464,864	⤷ Subscribe
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006	5,662,933	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Injection	20 units/mL, 1 mL	➤ Subscribe	2018-03-23
➤ Subscribe	Extended-release Tablets	7.5 mg and 15 mg	➤ Subscribe	2008-05-29
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2011-03-09
➤ Subscribe	Nasal Spray	500 mcg/spray	➤ Subscribe	2017-04-28
➤ Subscribe	Gel	1%	➤ Subscribe	2008-08-21
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	for Injection	100 mcg/vial and 500 mcg/vial	➤ Subscribe	2015-04-14
➤ Subscribe	Injection	1 mg/mL ampules	➤ Subscribe	2016-03-09
➤ Subscribe	Extended-release Tablets	5 mg, 10 mg, 20 mg and 40 mg	➤ Subscribe	2007-11-23
➤ Subscribe	Extended-release Tablets	30 mg	➤ Subscribe	2008-06-12
➤ Subscribe	Gel	10 mg/actuation	➤ Subscribe	2012-08-14
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	Injection	250 mg/mL	➤ Subscribe	2014-06-11
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	2012/018	Ireland	⤷ Subscribe	PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0285237	95C0008	Belgium	⤷ Subscribe	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0678503	C00678503/04	Switzerland	⤷ Subscribe	PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
3342411	LUC00148	Luxembourg	⤷ Subscribe	PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830
1441735	SPC/GB08/020	United Kingdom	⤷ Subscribe	PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
2465580	SPC/GB21/030	United Kingdom	⤷ Subscribe	PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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