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, 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.
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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Questions you can ask:
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Summary for EPHEDRINE SULFATE
| International Patents: | 1 |
| US Patents: | 2 |
| Applicants: | 15 |
| NDAs: | 19 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 and one FDA Regulatory Exclusivity.
| 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 | |||
| >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 | ⤷ Start 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 | 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 |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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