EPHEDRINE SULFATE Drug Patent Profile

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Ephedrine Sulfate is a drug marketed by Amneal, Caplin, Civica, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Mankind Pharma, Ph Health, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms. and is included in nineteen NDAs. There are two patents 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. Twenty-three suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

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

International Patents:	1
US Patents:	2
Applicants:	15
NDAs:	19
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

EPHEDRINE SULFATE is protected by two US patents and one FDA Regulatory Exclusivity.

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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	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	212932-001	Oct 23, 2019	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Renew Pharms	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	208609-001	Mar 1, 2017		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	209646-001	Aug 4, 2020	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Dr Reddys	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	212649-001	Oct 3, 2020	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150253		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France	⤷ Start Trial	PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543	SPC/GB08/005	United Kingdom	⤷ Start Trial	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.
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description