Isoproterenol hydrochloride - Generic Drug Details

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

Isoproterenol hydrochloride is the generic ingredient in six branded drugs marketed by 3M, Alpharma Us Pharms, Sanofi Aventis Us, Abbott, Abraxis Pharm, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Baxter Hlthcare, Cipla, Eugia Pharma, Hikma, Hospira, Intl Medication, Micro Labs, Mylan Labs Ltd, Nexus, Penn Life, Zydus Pharms, Bausch, Lilly, Armour Pharm, DEY, Parke Davis, and Fisons, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for isoproterenol hydrochloride. Twelve suppliers are listed for this compound.

Sponsor	Phase
The First Affiliated Hospital of Zhengzhou University	Phase 4
Peking Union Medical College Hospital	Phase 4
Fudan University	Phase 4

Sponsor

Phase

The First Affiliated Hospital of Zhengzhou University

Phase 4

Peking Union Medical College Hospital

Phase 4

Fudan University

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	210576-001	Oct 17, 2018	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fisons	VAPO-ISO	isoproterenol hydrochloride	SOLUTION;INHALATION	016813-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	ISUPREL	isoproterenol hydrochloride	TABLET;RECTAL, SUBLINGUAL	006328-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eugia Pharma	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	211864-001	Feb 9, 2021	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nexus	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	206961-001	Aug 2, 2017	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	214775-001	Oct 19, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	6
Applicants:	27
NDAs:	34
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	24
Patent Applications:	1,396
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in isoproterenol hydrochloride?	isoproterenol hydrochloride excipients list
DailyMed Link:	isoproterenol hydrochloride at DailyMed

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