Ephedrine Sulfate Patent Expiration

Ephedrine Sulfate was first introduced by Exela Pharma Sciences Llc in its drug Akovaz on Apr 29, 2016. Other drugs containing Ephedrine Sulfate are Emerphed, Ephedrine Sulfate, Corphedra. 15 different companies have introduced drugs containing Ephedrine Sulfate.


Ephedrine Sulfate Patents

Given below is the list of patents protecting Ephedrine Sulfate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Emerphed US11090278 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same May 16, 2040 Nexus
Emerphed US11241400 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same May 16, 2040 Nexus
Emerphed US11464752 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same May 16, 2040 Nexus
Emerphed US11478436 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same May 16, 2040 Nexus
Emerphed US11571398 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same May 16, 2040 Nexus
Ephedrine Sulfate US10869845 Ephedrine compositions and methods Jan 22, 2040 Endo Operations


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.

Given below is the list recent legal activities going on the following patents of Ephedrine Sulfate.

Event Date Patent/Publication
Patent litigations
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 30 Mar, 2023 US10869845(Litigated)
Change in Power of Attorney (May Include Associate POA) 29 Mar, 2023 US10869845(Litigated)
Correspondence Address Change 28 Mar, 2023 US10869845(Litigated)
Change in Power of Attorney (May Include Associate POA) 24 Feb, 2023 US10869845(Litigated)
Email Notification 24 Feb, 2023 US10869845(Litigated)
Correspondence Address Change 23 Feb, 2023 US10869845(Litigated)
Recordation of Patent Grant Mailed 22 Dec, 2020 US10869845(Litigated)
Patent Issue Date Used in PTA Calculation 22 Dec, 2020 US10869845(Litigated)



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Ephedrine Sulfate Generics

Several generic applications have been filed for Ephedrine Sulfate. The first generic version for Ephedrine Sulfate was by Sandoz Inc and was approved on Aug 23, 2017. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on May 16, 2023.

Given below is the list of companies who have filed for Ephedrine Sulfate generic.


1. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Oct 3, 2020


2. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Oct 23, 2019


3. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Dec 15, 2020


4. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Feb 25, 2022


5. XIROMED

Xiromed Pharma Espana Sl has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Apr 21, 2022


6. SANDOZ

Sandoz Inc has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Aug 23, 2017


7. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Jun 14, 2021


8. MANKIND PHARMA

Mankind Pharma Ltd has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Apr 14, 2022


9. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Aug 4, 2020


10. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Discontinued INTRAVENOUS N/A May 16, 2023


11. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 1 generic for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML) solution Prescription INTRAVENOUS AP Mar 9, 2023