EPHEDRINE HYDROCHLORIDE - Generic Drug Details

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

Ephedrine hydrochloride is the generic ingredient in one branded drug marketed by Dr Reddys Labs Sa and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for ephedrine hydrochloride. One supplier is listed for this compound.

Summary for EPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	273
Patent Applications:	998
What excipients (inactive ingredients) are in EPHEDRINE HYDROCHLORIDE?	EPHEDRINE HYDROCHLORIDE excipients list
DailyMed Link:	EPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for EPHEDRINE HYDROCHLORIDE

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

Sponsor	Phase
Ankara City Hospital Bilkent	N/A
Kasr El Aini Hospital	N/A
Jason Chui	Phase 4

See all EPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for EPHEDRINE HYDROCHLORIDE

Drug Class	Norepinephrine Releasing Agent alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for EPHEDRINE HYDROCHLORIDE

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

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for EPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	REZIPRES	ephedrine hydrochloride	SOLUTION;INTRAVENOUS	213536-002	Jun 14, 2021		DISCN	Yes	No
Dr Reddys Labs Sa	REZIPRES	ephedrine hydrochloride	SOLUTION;INTRAVENOUS	213536-003	Jun 14, 2021		DISCN	Yes	No
Dr Reddys Labs Sa	REZIPRES	ephedrine hydrochloride	SOLUTION;INTRAVENOUS	213536-004	Dec 7, 2023		RX	Yes	Yes
Dr Reddys Labs Sa	REZIPRES	ephedrine hydrochloride	SOLUTION;INTRAVENOUS	213536-001	Jun 14, 2021		DISCN	Yes	No