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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 Ephedrine Sulfate, Corphedra, Emerphed. 16 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
Ephedrine Sulfate US12029710 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.

Activity Date Patent Number
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
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)


Ephedrine Sulfate's Family Patents

Family Patents

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Ephedrine Sulfate Generic API Manufacturers

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 Fresenius Kabi Usa Llc and was approved on Mar 11, 2025.

Given below is the list of companies who have filed for Ephedrine Sulfate generic, along with the locations of their manufacturing plants worldwide.


1. 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


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Glasgow Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Bridgewater Amneal Complex Products Research LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





2. CAPLIN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML)

solution Prescription INTRAVENOUS AP Jul 18, 2024


Manufacturing Plant Locations
New

Caplin's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Caplin as present at those locations.

Country City Firm Name
United States
Creve Coeur Caplin, Dr David
India
Gummidipoondi Caplin Steriles Limited





3. 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





4. 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


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





5. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version 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
50MG/10ML (5MG/ML)

solution Prescription INTRAVENOUS AP2 Mar 11, 2025
25MG/5ML (5MG/ML)

solution Prescription INTRAVENOUS AP2 Mar 11, 2025


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Bensenville Fresenius Kabi USA LLC (FK USA)
Melrose Park Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Wilson Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC





6. GLAND

Gland Pharma Ltd has filed for 2 different strengths of generic version for Ephedrine Sulfate. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML (50MG/ML)

solution Prescription INTRAVENOUS AP Feb 25, 2022
50MG/10ML (5MG/ML)

solution Prescription INTRAVENOUS AP1 Jan 16, 2025


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited
Visakhapatnam Gland Pharma Limited
Sriperumbudur Gland Chemical Private Limited
Malur Gland Chemicals Pvt Ltd.





7. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version 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
25MG/5ML (5MG/ML)

solution Prescription INTRAVENOUS AP3 Oct 11, 2024


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





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


Manufacturing Plant Locations
New

Mankind Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Mankind Pharma as present at those locations.

Country City Firm Name
India
Paonta Sahib Mankind Pharma Limited
Imt Manesar Mankind Pharma Limited





9. 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





10. 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


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





11. 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


Manufacturing Plant Locations
New

Xiromed's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC





12. 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