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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-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:	38
Ingredients:	35
NDAs:	45
Patent Litigation for Alvogen:	See patent lawsuits for Alvogen

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	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	202133-001	Oct 6, 2011	AB	RX	Yes	Yes
Alvogen Inc	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	203924-001	Feb 3, 2014	AB	RX	No	No
Alvogen Pine Brook	OSELTAMIVIR PHOSPHATE	oseltamivir phosphate	FOR SUSPENSION;ORAL	208823-001	Oct 31, 2017	AB	RX	No	No
Alvogen Malta	ZESTRIL	lisinopril	TABLET;ORAL	019777-006	Jan 20, 1999	AB	RX	Yes	No
Alvogen Pine Brook	ESTRADIOL	estradiol	CREAM;VAGINAL	209767-001	Mar 5, 2018	AB	RX	No	No
Alvogen	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497-001	Nov 10, 2011		RX	Yes	Yes	7,674,479		Y

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	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993	5,264,446
Alvogen Malta	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-002	Jul 20, 1989	4,374,829*PED
Alvogen Malta	ZESTRIL	lisinopril	TABLET;ORAL	019777-005	Apr 29, 1993	4,374,829*PED
Alvogen Malta	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,836,671
Alvogen Malta	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,934,032

Paragraph IV (Patent) Challenges for ALVOGEN drugs

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

Non-Orange Book US Patents for Alvogen

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,703,191	Controlled-release pharmaceutical tablets

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
90064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C/GB01/047	United Kingdom		PRODUCT NAME: NATEGLINIDE; REGISTERED: CH 55401 01 20000928; CH 55401 02 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403

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