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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Last Updated: November 18, 2019

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Hydrochlorothiazide; lisinopril - Generic Drug Details

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What are the generic drug sources for hydrochlorothiazide; lisinopril and what is the scope of freedom to operate?

Hydrochlorothiazide; lisinopril is the generic ingredient in three branded drugs marketed by Apotex Inc, Aurobindo, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Mylan, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, Watson Labs, Merck, and Alvogen, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; lisinopril. Thirty-four suppliers are listed for this compound.

Recent Clinical Trials for hydrochlorothiazide; lisinopril

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SponsorPhase
IPCA Laboratories Ltd.Phase 1
Scripps Translational Science InstituteN/A
Novartis PharmaceuticalsPhase 4

See all hydrochlorothiazide; lisinopril clinical trials

Recent Litigation for hydrochlorothiazide; lisinopril

Identify potential future generic entrants

District Court Litigation
Case NameDate
Apotex, Inc. v. Mylan Pharmaceuticals, Inc.2012-04-20
Apotex, Inc. v. UCB, Inc.2012-04-20

See all hydrochlorothiazide; lisinopril litigation

Pharmacology for hydrochlorothiazide; lisinopril

US Patents and Regulatory Information for hydrochlorothiazide; lisinopril

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077912-003 Sep 27, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 076230-001 Jul 1, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077912-002 Sep 27, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Merck PRINZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 019778-001 Feb 16, 1989 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sandoz LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 075926-001 Jul 1, 2002 DISCN No 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 hydrochlorothiazide; lisinopril

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-002 Jul 20, 1989   Start Trial   Start Trial
Merck PRINZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 019778-003 Nov 18, 1993   Start Trial   Start Trial
Merck PRINZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 019778-001 Feb 16, 1989   Start Trial   Start Trial
Merck PRINZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 019778-002 Feb 16, 1989   Start Trial   Start Trial
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-003 Nov 18, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.