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:

Express Scripts
AstraZeneca
Baxter
Mallinckrodt
Johnson and Johnson
Merck

Last Updated: December 15, 2019

DrugPatentWatch Database Preview

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - Generic Drug Details

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What are the generic drug sources for hydralazine hydrochloride; isosorbide dinitrate and what is the scope of freedom to operate?

Hydralazine hydrochloride; isosorbide dinitrate is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydralazine hydrochloride; isosorbide dinitrate has four patent family members in four countries.

There are twenty-one drug master file entries for hydralazine hydrochloride; isosorbide dinitrate. One supplier is listed for this compound.

Summary for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
International Patents:4
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 21
Suppliers / Packagers: 1
Clinical Trials: 7
DailyMed Link:HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE at DailyMed
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Danish Heart FoundationPhase 4
The Novo Nordisk FoundationPhase 4
The Aase og Ejnar Danielsen FoundationPhase 4

See all HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE clinical trials

Pharmacology for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Medtronic
Dow
Boehringer Ingelheim
Colorcon

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.