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Last Updated: March 28, 2024

EPHEDRINE SULFATE - Generic Drug Details


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What are the generic drug sources for ephedrine sulfate and what is the scope of patent protection?

Ephedrine sulfate is the generic ingredient in four branded drugs marketed by Exela Pharma, Par Sterile Products, Nexus, 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 sixteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ephedrine sulfate has eleven patent family members in nine countries.

There are thirteen drug master file entries for ephedrine sulfate. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EPHEDRINE SULFATE
International Patents:11
US Patents:6
Tradenames:4
Applicants:16
NDAs:16
Drug Master File Entries: 13
Finished Product Suppliers / Packagers: 18
Raw Ingredient (Bulk) Api Vendors: 21
Clinical Trials: 14
Patent Applications: 984
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

SponsorPhase
Instituto Mexicano del Seguro SocialPhase 4
Fayoum UniversityPhase 1
Ain Shams UniversityN/A

See all EPHEDRINE SULFATE clinical trials

Generic filers with tentative approvals for EPHEDRINE SULFATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial50MG/ML (50MG/ML)SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Renew Pharms EPHEDRINE SULFATE ephedrine sulfate SOLUTION;INTRAVENOUS 208609-001 Mar 1, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed EPHEDRINE SULFATE ephedrine sulfate SOLUTION;INTRAVENOUS 215825-001 Apr 21, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nexus EMERPHED ephedrine sulfate SOLUTION;INTRAVENOUS 213407-001 Apr 17, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc EPHEDRINE SULFATE ephedrine sulfate SOLUTION;INTRAVENOUS 214528-001 Mar 9, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products CORPHEDRA ephedrine sulfate SOLUTION;INTRAVENOUS 208943-001 Jan 27, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Exela Pharma AKOVAZ ephedrine sulfate SOLUTION;INTRAVENOUS 208289-001 Apr 29, 2016 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nexus EMERPHED ephedrine sulfate SOLUTION;INTRAVENOUS 213407-002 Feb 28, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Country Patent Number Title Estimated Expiration
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) ⤷  Try a Trial
Australia 2020276619 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same ⤷  Try a Trial
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) ⤷  Try a Trial
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 ⤷  Try a Trial
Israel 288044 תכשירים המכילים אפהרדין או מלח אפהרדין ושיטות להכנתם ולשימוש בהם (Compositions comprising ephedrine or an ephedrine salt and methods of making and using same) ⤷  Try a Trial
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) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2021150253 ⤷  Try a Trial
>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 ⤷  Try a 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.
1110543 08C0004 France ⤷  Try a Trial 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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