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:	117
Patent Applications:	1,083
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
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu	N/A
Koç University	N/A
Wuhan Union Hospital, China	Phase 2/Phase 3

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
Lilly	DOBUTREX	dobutamine hydrochloride	INJECTABLE;INJECTION	017820-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	dobutamine hydrochloride	INJECTABLE;INJECTION	020269-001	Oct 19, 1993		DISCN	No	No
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	dobutamine hydrochloride	INJECTABLE;INJECTION	020269-002	Oct 19, 1993		DISCN	No	No
Luitpold	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074545-001	Jun 25, 1998		DISCN	No	No
Baxter Hlthcare	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dobutamine hydrochloride	INJECTABLE;INJECTION	020255-003	Oct 19, 1993	AP	RX	Yes	Yes
Baxter Hlthcare	DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074381-001	Sep 26, 1996		DISCN	No	No
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dobutamine hydrochloride	INJECTABLE;INJECTION	020201-002	Oct 19, 1993	AP	RX	Yes	Yes

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