EPHEDRINE SULFATE Drug Patent Profile

Which patents cover Ephedrine Sulfate, and when can generic versions of Ephedrine Sulfate launch?

Ephedrine Sulfate is a drug marketed by Amneal, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mankind Pharma, Operand Pharms, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms. and is included in thirteen NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in EPHEDRINE SULFATE is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ephedrine Sulfate

A generic version of EPHEDRINE SULFATE was approved as ephedrine sulfate by SANDOZ on August 23^rd, 2017.

Summary for EPHEDRINE SULFATE

International Patents:	1
US Patents:	1
Applicants:	13
NDAs:	13
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	14
Patent Applications:	621
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in EPHEDRINE SULFATE?	EPHEDRINE SULFATE excipients list
DailyMed Link:	EPHEDRINE SULFATE at DailyMed

Recent Clinical Trials for EPHEDRINE SULFATE

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	Phase 4
Fayoum University	Phase 1
Ain Shams University	N/A

See all EPHEDRINE SULFATE clinical trials

Pharmacology for EPHEDRINE SULFATE

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

Medical Subject Heading (MeSH) Categories for EPHEDRINE SULFATE

Adrenergic Agents

Central Nervous System Stimulants

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for EPHEDRINE SULFATE

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

Paragraph IV (Patent) Challenges for EPHEDRINE SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPHEDRINE SULFATE	Injection	ephedrine sulfate	25 mg/5 mL and 50 mg/10 mL	213994	1	2023-03-17
EMERPHED	Injection	ephedrine sulfate	50 mg/10 mL	213407	1	2021-10-14

US Patents and Regulatory Information for EPHEDRINE SULFATE

EPHEDRINE SULFATE is protected by one US patents.

Patents protecting EPHEDRINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	212932-001	Oct 23, 2019	AP	RX	No	No
Mankind Pharma	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	216129-001	Apr 14, 2022	AP	RX	No	No
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	209646-001	Aug 4, 2020	AP	RX	No	No

International Patents for EPHEDRINE SULFATE

See the table below for patents covering EPHEDRINE SULFATE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150253

Supplementary Protection Certificates for EPHEDRINE SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730