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Alvogen Company Profile

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

ALVOGEN has forty-six 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:	41
Ingredients:	38
NDAs:	46
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	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	204403-001	Sep 3, 2015	AB	RX	No	No
Alvogen Malta	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	AB	RX	Yes	No
Alvogen Malta	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	207388-006	Jul 28, 2017	AB	RX	No	No
Alvogen	DAPSONE	dapsone	TABLET;ORAL	205429-001	Jan 7, 2016	AB	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
Alvogen Malta	NATEGLINIDE	nateglinide	TABLET;ORAL	205055-001	Dec 11, 2015	AB	RX	No	No
Alvogen Malta	ZESTRIL	lisinopril	TABLET;ORAL	019777-002	May 19, 1988	AB	RX	Yes	No

Expired US Patents for Alvogen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen Malta	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,836,671
Alvogen Malta	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	3,663,607
Alvogen Malta	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,836,671
Alvogen	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993	4,892,741
Alvogen Malta	ZESTRIL	lisinopril	TABLET;ORAL	019777-003	May 19, 1988	4,374,829*PED
Alvogen	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993	5,264,446
Alvogen Malta	SPECTAZOLE	econazole nitrate	CREAM;TOPICAL	018751-001	Dec 23, 1982	3,717,655

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
0918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
09/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
C/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
1411900/01	Switzerland		PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115

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