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Alvogen Company Profile

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

ALVOGEN has forty-five approved drugs.

There is one US patent protecting ALVOGEN drugs.

There is one patent family member on ALVOGEN drugs in one country and one hundred and fourteen supplementary protection certificates in twelve countries.

Summary for Alvogen

International Patents:	1
US Patents:	1
Tradenames:	40
Ingredients:	37
NDAs:	45
Patent Litigation for Alvogen:	See patent lawsuits for Alvogen
PTAB Cases with Alvogen as petitioner:	See PTAB cases with Alvogen as petitioner

Drugs and US Patents for Alvogen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen Malta	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	202116-001	Dec 30, 2011	AB	RX	No	No
Alvogen Malta	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	202677-003	Mar 8, 2016	AA	RX	No	No
Alvogen Malta	ZESTRIL	lisinopril	TABLET;ORAL	019777-002	May 19, 1988	AB	RX	Yes	No
Alvogen Pine Brook	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	209958-004	Oct 24, 2018	AA	RX	No	No
Alvogen Malta	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	207388-007	Jul 28, 2017	AB	RX	No	No

Expired US Patents for Alvogen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen Malta	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-003	Nov 18, 1993	4,472,380
Alvogen Malta	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,663,607
Alvogen Malta	ZESTRIL	lisinopril	TABLET;ORAL	019777-004	May 19, 1988	4,374,829*PED
Alvogen Malta	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,934,032
Alvogen Malta	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	5,637,320

Paragraph IV (Patent) Challenges for ALVOGEN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	450 mg		2013-02-28

International Patents for Alvogen Drugs

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for Alvogen Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
13/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
90022	Netherlands		PRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223
C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Similar Applicant Names

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

• Alvogen
• Alvogen Inc
• Alvogen Malta
• Alvogen Pine Brook