Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Medtronic
Moodys
Harvard Business School
Johnson and Johnson

Last Updated: December 6, 2019

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Alvogen Company Profile

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Summary 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 NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-003 Jan 5, 1996 AB RX Yes Yes   Start Trial   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 AB RX Yes No   Start Trial   Start Trial
Alvogen THYRO-TABS levothyroxine sodium TABLET;ORAL 021116-002 Oct 24, 2002 AB2,AB4 RX Yes No   Start Trial   Start Trial
Alvogen Inc ACETYLCYSTEINE acetylcysteine SOLUTION;INHALATION, ORAL 204674-001 Feb 11, 2014 AN RX No No   Start Trial   Start Trial
Alvogen Inc CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 062943-001 Sep 29, 1988 AP RX No No   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Alvogen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-003 Nov 18, 1993 4,472,380   Start Trial
Alvogen TENORMIN atenolol TABLET;ORAL 018240-001 Approved Prior to Jan 1, 1982 3,663,607   Start Trial
Alvogen ZESTRIL lisinopril TABLET;ORAL 019777-004 May 19, 1988 4,374,829*PED   Start Trial
Alvogen TENORMIN atenolol TABLET;ORAL 018240-002 Approved Prior to Jan 1, 1982 3,934,032   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 5,637,320   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ALVOGEN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 450 mg ➤ Subscribe 2013-02-28

Supplementary Protection Certificates for Alvogen Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0206283 98C0041 Belgium   Start Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283 SPC/GB97/085 United Kingdom   Start Trial PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0770388 PA2009004,C0770388 Lithuania   Start Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0984957 PA2011005,C0984957 Lithuania   Start Trial PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Mallinckrodt
Express Scripts
McKesson
AstraZeneca

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