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Norepinephrine Bitartrate Patent Expiration

Norepinephrine Bitartrate is Used for increasing blood pressure in adult patients with severe, acute hypotension. It was first introduced by Hospira Inc in its drug Levophed on Approved Prior to Jan 1, 1982. Other drugs containing Norepinephrine Bitartrate are Norepinephrine Bitartrate In 5% Dextrose, Norepinephrine Bitartrate In 0.9% Sodium Chloride. 19 different companies have introduced drugs containing Norepinephrine Bitartrate.


Norepinephrine Bitartrate Patents

Given below is the list of patents protecting Norepinephrine Bitartrate, 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
Norepinephrine Bitartrate In 5% Dextrose US12097170 Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation Mar 08, 2041 Baxter Hlthcare Corp
Norepinephrine Bitartrate In 0.9% Sodium Chloride US10888534 Storage stable ready-to-use norepinephrine aqueous solutions in flexible plastic bags Apr 26, 2039 Inforlife
Norepinephrine Bitartrate In 0.9% Sodium Chloride US10159657 Norepinephrine compositions and methods therefor Jan 30, 2038 Long Grove Pharms
Norepinephrine Bitartrate In 0.9% Sodium Chloride US10226436 Norepinephrine compositions and methods therefor Jan 30, 2038 Long Grove Pharms
Norepinephrine Bitartrate In 0.9% Sodium Chloride US10420735 Norepinephrine compositions and methods therefor Jan 30, 2038 Long Grove Pharms
Norepinephrine Bitartrate In 0.9% Sodium Chloride US10568850 Norepinephrine compositions and methods therefor Jan 30, 2038 Long Grove Pharms
Norepinephrine Bitartrate In 0.9% Sodium Chloride US11413259 Norepinephrine compositions and methods therefor Jan 30, 2038 Long Grove Pharms
Norepinephrine Bitartrate In 0.9% Sodium Chloride US11602508 Norepinephrine compositions and methods therefor Jan 30, 2038 Long Grove Pharms



Norepinephrine Bitartrate's Family Patents

Family Patents

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Norepinephrine Bitartrate Generic API Manufacturers

Several generic applications have been filed for Norepinephrine Bitartrate. The first generic version for Norepinephrine Bitartrate was by Meitheal Pharmaceuticals Inc and was approved on Mar 3, 2003. And the latest generic version is by Biocon Pharma Ltd and was approved on Mar 21, 2025.

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


1. AMNEAL

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Dec 17, 2018


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





2. ASPIRO

Aspiro Pharma Ltd has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Aspiro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Jan 31, 2025


Manufacturing Plant Locations
New

Aspiro'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 Aspiro as present at those locations.

Country City Firm Name
India
Siddipet (Dist) Aspiro Pharma Limited





3. BAXTER HLTHCARE CORP

Baxter Healthcare Corp has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Mar 27, 2012





4. BIOCON PHARMA

Biocon Pharma Ltd has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Mar 21, 2025


Manufacturing Plant Locations
New

Biocon 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 Biocon Pharma as present at those locations.

Country City Firm Name
India
Bengaluru Biocon Pharma Limited





5. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Jan 22, 2021


Manufacturing Plant Locations
New

Breckenridge'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 Breckenridge as present at those locations.

Country City Firm Name
United States
Berlin Breckenridge Pharmaceutical, Inc
Boca Raton Breckenridge Pharmaceutical, Inc.





6. CAPLIN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Sep 15, 2023


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





7. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Norepinephrine Bitartrate. 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
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Nov 3, 2020


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
Lake Zurich Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Wilson Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC





8. GLAND

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP May 6, 2021


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





9. HIKMA

Hikma Farmaceutica Portugal Sa has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Nov 7, 2018


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.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





10. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Mar 3, 2003





11. METRICS PHARM

Metrics Pharmaceutical Ventures Llc has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Metrics Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Discontinued INJECTION N/A Sep 30, 2004





12. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Oct 4, 2018





13. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP May 13, 2024


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Fort Bragg Rising Tide Sea Vegetables
Rising Sun Rising Sun Veterinary Clinic
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





14. SANDOZ

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Oct 18, 2018


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





15. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Norepinephrine Bitartrate. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Discontinued INJECTION N/A Jan 29, 2021


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
India
Ahmednagar Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Dadra Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Punjab Sun Pharmaceutical Industries, Inc.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Halol Sun Pharmaceutical Industries Ltd.
Bharuch Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Mohali Sun Pharmaceutical Industries Limited





16. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Norepinephrine Bitartrate. 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
EQ 1MG BASE/ML

injectable Discontinued INJECTION N/A Jul 19, 2022