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Last Updated: October 1, 2020

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MONOPRIL Drug Profile

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Summary for MONOPRIL
Drug patent expirations by year for MONOPRIL
Recent Clinical Trials for MONOPRIL

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SponsorPhase
University of NebraskaPhase 4
Ranbaxy Laboratories LimitedN/A

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Paragraph IV (Patent) Challenges for MONOPRIL
Tradename Dosage Ingredient NDA Submissiondate
MONOPRIL TABLET;ORAL fosinopril sodium 019915

US Patents and Regulatory Information for MONOPRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-002 Nov 30, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-004 Mar 28, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL-HCT fosinopril sodium; hydrochlorothiazide TABLET;ORAL 020286-001 Nov 30, 1994 DISCN Yes No   Start Trial   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 MONOPRIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-004 Mar 28, 1995   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-003 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
Bristol Myers Squibb MONOPRIL fosinopril sodium TABLET;ORAL 019915-002 May 16, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MONOPRIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0053902 SPC/GB96/024 United Kingdom   Start Trial SPC/GB96/024:, EXPIRES: 20061126
0053902 96C0036 Belgium   Start Trial PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
0053902 SPC/GB93/028 United Kingdom   Start Trial SPC/GB93/028, EXPIRES: 20050702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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