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Last Updated: November 22, 2024

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-two 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 23rd, 2017.

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Summary for EPHEDRINE SULFATE
Drug patent expirations by year for EPHEDRINE SULFATE
Drug Prices for EPHEDRINE SULFATE

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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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Patent Expiration: ⤷  Sign Up


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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CLINICALLY IMPORTANT HYPOTENSION OCCURRING IN THE SETTING OF ANESTHESIA

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
Sandoz EPHEDRINE SULFATE ephedrine sulfate SOLUTION;INTRAVENOUS 209784-001 Aug 23, 2017 AP RX 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.

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

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.