EPHEDRINE SULFATE Drug Patent Profile

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When do Ephedrine Sulfate patents expire, and what generic alternatives are available?

Ephedrine Sulfate is a drug marketed by Amneal, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mankind Pharma, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms. and is included in fourteen 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-one 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.

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Summary for EPHEDRINE SULFATE

International Patents:	1
US Patents:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	14
Patent Applications:	551
Drug Prices:	Drug price information for EPHEDRINE SULFATE
What excipients (inactive ingredients) are in EPHEDRINE SULFATE?	EPHEDRINE SULFATE excipients list
DailyMed Link:	EPHEDRINE SULFATE at DailyMed

Drug patent expirations by year for EPHEDRINE SULFATE

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

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 two US patents.

Patents protecting EPHEDRINE SULFATE

Ephedrine compositions and methods
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Patented Use: TREATMENT OF CLINICALLY IMPORTANT HYPOTENSION OCCURRING IN THE SETTING OF ANESTHESIA

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	214579-001	Jun 14, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-002	Apr 22, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Renew Pharms	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	208609-001	Mar 1, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	209646-001	Aug 4, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	217276-001	May 16, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for EPHEDRINE SULFATE

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		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EPHEDRINE SULFATE

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