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Last Updated: August 4, 2020

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DOBUTAMINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for dobutamine hydrochloride and what is the scope of freedom to operate?

Dobutamine hydrochloride is the generic ingredient in four branded drugs marketed by Baxter Hlthcare, Dr Reddys, Hospira, Luitpold, Teligent Pharma Inc, Teva Parenteral, Watson Labs, Watson Labs Inc, West-ward Pharms Int, and Lilly, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for dobutamine hydrochloride. Five suppliers are listed for this compound.

Recent Clinical Trials for DOBUTAMINE HYDROCHLORIDE

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

SponsorPhase
Centre d’Investigation Clinique 1415Phase 3
University Hospital, LimogesPhase 3
Northwell HealthEarly Phase 1

See all DOBUTAMINE HYDROCHLORIDE clinical trials

Pharmacology for DOBUTAMINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOBUTAMINE HYDROCHLORIDE

US Patents and Regulatory Information for DOBUTAMINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-003 Oct 19, 1993 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Luitpold DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074545-001 Jun 25, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020201-006 Jul 7, 1994 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074292-001 Feb 16, 1995 AP RX No Yes   Start Trial   Start Trial   Start Trial
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074381-001 Sep 26, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Teligent Pharma Inc DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074098-001 Feb 21, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074086-001 Nov 29, 1993 AP RX 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

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