Dobutamine hydrochloride - Generic Drug Details

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, Hikma, Hospira, Luitpold, Slate Run Pharma, Teligent, Teva Parenteral, Watson Labs, Watson Labs Inc, and Lilly, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for dobutamine hydrochloride. Six suppliers are listed for this compound.

Summary for dobutamine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	16
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	129
What excipients (inactive ingredients) are in dobutamine hydrochloride?	dobutamine hydrochloride excipients list
DailyMed Link:	dobutamine hydrochloride at DailyMed

Recent Clinical Trials for dobutamine hydrochloride

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

Sponsor	Phase
Pi Research and Development Center, Bangladesh	PHASE2
Beacon Pharmaceuticals PLC	PHASE2
Chittagong Medical College	PHASE2

See all dobutamine hydrochloride clinical trials

Pharmacology for dobutamine hydrochloride

Drug Class	beta-Adrenergic Agonist
Mechanism of Action	Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for dobutamine hydrochloride

Adrenergic beta-1 Receptor Agonists

Cardiotonic Agents

Sympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for dobutamine hydrochloride

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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
Watson Labs	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074114-001	Nov 30, 1993		DISCN	No	No
Hikma	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074277-001	Oct 31, 1994	AP	RX	No	No
Baxter Hlthcare	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dobutamine hydrochloride	INJECTABLE;INJECTION	020255-005	Oct 19, 1993	AP	RX	Yes	Yes
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	dobutamine hydrochloride	INJECTABLE;INJECTION	020269-002	Oct 19, 1993		DISCN	No	No
Slate Run Pharma	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	216131-001	Dec 21, 2022	AP	RX	No	No
Dr Reddys	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074995-001	Mar 31, 1998		DISCN	No	No
Teligent	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074098-001	Feb 21, 1995		DISCN	No	No

Expired US Patents for dobutamine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	DOBUTREX	dobutamine hydrochloride	INJECTABLE;INJECTION	017820-002	Approved Prior to Jan 1, 1982