Ephedrine Sulfate is a drug owned by Endo Operations Ltd. It is protected by 2 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 22, 2040. Details of Ephedrine Sulfate's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12029710 | Ephedrine compositions and methods |
Jan, 2040
(14 years from now) | Active |
| US10869845 | Ephedrine compositions and methods |
Jan, 2040
(14 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ephedrine Sulfate's patents.
Latest Legal Activities on Ephedrine Sulfate's Patents
Given below is the list of recent legal activities going on the following patents of Ephedrine Sulfate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jun, 2024 | US10869845 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 30 May, 2024 | US10869845 (Litigated) |
| Email Notification Critical | 30 Mar, 2023 | US10869845 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Mar, 2023 | US10869845 (Litigated) |
| Correspondence Address Change Critical | 28 Mar, 2023 | US10869845 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 24 Feb, 2023 | US10869845 (Litigated) |
| Email Notification Critical | 24 Feb, 2023 | US10869845 (Litigated) |
| Correspondence Address Change Critical | 23 Feb, 2023 | US10869845 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 22 Dec, 2020 | US10869845 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 22 Dec, 2020 | US10869845 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Ephedrine Sulfate is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ephedrine Sulfate's family patents as well as insights into ongoing legal events on those patents.
Ephedrine Sulfate's Family Patents
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Generic Launch
Generic Release Date:
Ephedrine Sulfate's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 22, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ephedrine Sulfate Generic API suppliers:
Ephedrine Sulfate is the generic name for the brand Ephedrine Sulfate. 12 different companies have already filed for the generic of Ephedrine Sulfate, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ephedrine Sulfate's generic
How can I launch a generic of Ephedrine Sulfate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ephedrine Sulfate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ephedrine Sulfate's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ephedrine Sulfate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/5 mL and 50 mg/10 mL | 17 Mar, 2023 | 1 | 22 Jan, 2040 |
Alternative Brands for Ephedrine Sulfate
There are several other brand drugs using the same active ingredient (Ephedrine Sulfate) as Ephedrine Sulfate. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Bayer Healthcare Llc |
| |
| Nexus |
| |
| Organon |
| |
| Organon Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ephedrine Sulfate, Ephedrine Sulfate's active ingredient. Check the complete list of approved generic manufacturers for Ephedrine Sulfate
About Ephedrine Sulfate
Ephedrine Sulfate is a drug owned by Endo Operations Ltd. Ephedrine Sulfate uses Ephedrine Sulfate as an active ingredient. Ephedrine Sulfate was launched by Endo Operations in 2022.
Approval Date:
Ephedrine Sulfate was approved by FDA for market use on 22 April, 2022.
Active Ingredient:
Ephedrine Sulfate uses Ephedrine Sulfate as the active ingredient. Check out other Drugs and Companies using Ephedrine Sulfate ingredient
Dosage:
Ephedrine Sulfate is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG/5ML (5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 50MG/10ML (5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |