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 23rd, 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 |
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 |
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
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
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 |