ISOPROTERENOL HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for isoproterenol hydrochloride and what is the scope of patent protection?

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. Eleven 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
Cipla	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	210322-001	Jun 12, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Penn Life	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	215542-001	Sep 20, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	215557-001	Apr 14, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Armour Pharm	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	SOLUTION;INHALATION	087935-001	Nov 18, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	ISUPREL	isoproterenol hydrochloride	INJECTABLE;INJECTION	010515-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	212573-001	Sep 6, 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:	11
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