EMERPHED Drug Patent Profile

When do Emerphed patents expire, and when can generic versions of Emerphed launch?

Emerphed is a drug marketed by Nexus and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emerphed

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

Summary for EMERPHED

International Patents:	10
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	621
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EMERPHED
What excipients (inactive ingredients) are in EMERPHED?	EMERPHED excipients list
DailyMed Link:	EMERPHED at DailyMed

See drug prices for EMERPHED

Pharmacology for EMERPHED

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 EMERPHED

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 EMERPHED

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMERPHED	Injection	ephedrine sulfate	50 mg/10 mL	213407	1	2021-10-14

US Patents and Regulatory Information for EMERPHED

EMERPHED is protected by five US patents.

Patents protecting EMERPHED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020		RX	Yes	Yes			Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020		RX	Yes	Yes
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes			Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020		RX	Yes	Yes
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020		RX	Yes	Yes

International Patents for EMERPHED

See the table below for patents covering EMERPHED around the world.

Country	Patent Number	Title	Estimated Expiration
China	113825500	包含麻黄碱或麻黄碱盐的组合物及其制备和使用方法 (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME)
Canada	3140043	COMPOSITIONS COMPRENANT DE L'EPHEDRINE OU UN SEL D'EPHEDRINE ET LEURS PROCEDES DE FABRICATION ET D'UTILISATION (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME)
Japan	2023091072	エフェドリンまたはエフェドリン塩を含む組成物ならびにその組成物を作製する方法および使用する方法 (COMPOSITIONS COMPRISING EPHEDRINE OR EPHEDRINE SALT AND METHODS OF MAKING AND USING THOSE COMPOSITIONS)
South Korea	20220009985	에페드린 또는 에페드린 염을 포함하는 조성물 및 그의 제조 및 사용 방법
Japan	2022532657	エフェドリンまたはエフェドリン塩を含む組成物ならびにその組成物を作製する方法および使用する方法
European Patent Office	3968975	COMPOSITIONS COMPRENANT DE L'ÉPHÉDRINE OU UN SEL D'ÉPHÉDRINE ET LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME)

Supplementary Protection Certificates for EMERPHED

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