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, Endo Operations, Nexus, Amneal, Caplin, Dr Reddys, 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 seventeen NDAs. There are seven 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. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for EPHEDRINE SULFATE
International Patents: | 11 |
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 16 |
NDAs: | 17 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 21 |
Clinical Trials: | 14 |
Patent Applications: | 891 |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for EPHEDRINE SULFATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 50MG/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.
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 209784-001 | Aug 23, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 212649-001 | Oct 3, 2020 | 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 | ||||
Nexus | EMERPHED | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213407-001 | Apr 17, 2020 | RX | Yes | Yes | ⤷ 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 | |||
>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 |
---|---|---|---|
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) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2021150253 | ⤷ Sign Up | |
Mexico | 2021013888 | COMPOSICIONES QUE COMPRENDEN EFEDRINA O UNA SAL DE EFEDRINA Y METODOS DE FABRICACION Y USO DE LAS MISMAS. (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME.) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2020232424 | ⤷ Sign Up | |
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) | ⤷ 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 | 08C0004 | France | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
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. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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