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Nicardipine Hydrochloride Patent Expiration

Nicardipine Hydrochloride is Used for lowering acute elevations of blood pressure in human subjects. It was first introduced by Chiesi Usa Inc in its drug Cardene on Dec 21, 1988. Other drugs containing Nicardipine Hydrochloride are Cardene In 5.0% Dextrose In Plastic Container, Cardene In 0.83% Sodium Chloride In Plastic Container, Cardene In 4.8% Dextrose In Plastic Container, Nicardipine Hydrochloride In 0.9% Sodium Chloride, Cardene Sr, Cardene In 0.86% Sodium Chloride In Plastic Container, Nicardipine Hydrochloride. 21 different companies have introduced drugs containing Nicardipine Hydrochloride.


Nicardipine Hydrochloride Patents

Given below is the list of patents protecting Nicardipine Hydrochloride, 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
Cardene In 0.83% Sodium Chloride In Plastic Container US7612102 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 0.83% Sodium Chloride In Plastic Container US9364564 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 0.86% Sodium Chloride In Plastic Container US7612102 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 0.86% Sodium Chloride In Plastic Container US9364564 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 4.8% Dextrose In Plastic Container US7612102 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 4.8% Dextrose In Plastic Container US9364564 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 5.0% Dextrose In Plastic Container US7612102 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 5.0% Dextrose In Plastic Container US9364564 Pre-mixed, ready-to-use pharmaceutical compositions Dec 26, 2027 Chiesi
Cardene In 0.83% Sodium Chloride In Plastic Container US10758616 Pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.83% Sodium Chloride In Plastic Container US11547758 Pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.83% Sodium Chloride In Plastic Container US7659291 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.83% Sodium Chloride In Plastic Container US8455524 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.86% Sodium Chloride In Plastic Container US10758616 Pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.86% Sodium Chloride In Plastic Container US11547758 Pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.86% Sodium Chloride In Plastic Container US7659291 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 0.86% Sodium Chloride In Plastic Container US8455524 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 4.8% Dextrose In Plastic Container US10758616 Pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 4.8% Dextrose In Plastic Container US11547758 Pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 4.8% Dextrose In Plastic Container US7659291 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 4.8% Dextrose In Plastic Container US8455524 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 5.0% Dextrose In Plastic Container US7659291 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi
Cardene In 5.0% Dextrose In Plastic Container US8455524 Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions Apr 18, 2027 Chiesi



Nicardipine Hydrochloride's Family Patents

Family Patents

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Nicardipine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Nicardipine Hydrochloride. The first generic version for Nicardipine Hydrochloride was by Norvium Bioscience Llc and was approved on Jul 18, 1996. And the latest generic version is by Amneal Eu Ltd and was approved on Oct 31, 2024.

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


1. AM REGENT

American Regent Inc has filed for 1 generic for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

(reference standard)

injectable Prescription INJECTION AP Nov 17, 2009





2. AMNEAL

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Discontinued INJECTION N/A Oct 31, 2024


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





3. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

capsule Discontinued ORAL N/A Dec 10, 1996
30MG

capsule Discontinued ORAL N/A Dec 10, 1996





4. BIONPHARMA

Bionpharma Inc has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG

capsule Prescription ORAL AB May 3, 2023
20MG

capsule Prescription ORAL AB May 3, 2023


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





5. CHENGDU SHUODE

Chengdu Shuode Pharmaceutical Co Ltd has filed for 1 generic for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Chengdu Shuode.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Prescription INJECTION AP Sep 6, 2024





6. CIPLA

Cipla Ltd has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. All of these versions come by the name NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/200ML (0.1MG/ML)

injectable Prescription INTRAVENOUS AP Sep 24, 2024
40MG/200ML (0.2MG/ML)

injectable Prescription INTRAVENOUS AP Sep 24, 2024


Manufacturing Plant Locations
New

Cipla'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 Cipla as present at those locations.

Country City Firm Name
India
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Mumbai Cipla Limited
Vasco Da Gama Cipla Limited
Bangalore Cipla Ltd.
Pithampur, District Dhar Cipla Limited
Bengaluru Cipla Limited
Raigad Cipla Limited





7. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG

(reference standard)

capsule Prescription ORAL AB Mar 19, 1998
20MG

capsule Prescription ORAL AB Mar 19, 1998





8. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Nicardipine Hydrochloride. 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
25MG/10ML (2.5MG/ML)

injectable Prescription INJECTION AP Apr 8, 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
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





9. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG

capsule Prescription ORAL AB Dec 16, 2022
20MG

capsule Prescription ORAL AB Dec 16, 2022





10. HIKMA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Discontinued INJECTION N/A Dec 28, 2009


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





11. INFORLIFE

Inforlife Sa has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Out of these 20mg/200ml (0.1mg/ml) version comes by the name NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE, 40mg/200ml (0.2mg/ml) version comes by the name NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE. Given below are the details of the strengths of this generic introduced by Inforlife.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/200ML (0.1MG/ML)

injectable Prescription INTRAVENOUS AP Apr 17, 2024
40MG/200ML (0.2MG/ML)

injectable Prescription INTRAVENOUS AP Apr 17, 2024


Manufacturing Plant Locations
New

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

Country City Firm Name
Switzerland
Campascio InfoRLife SA





12. MICRO LABS

Micro Labs Ltd has filed for 1 generic for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Prescription INJECTION AP Jul 7, 2023


Manufacturing Plant Locations
New

Micro Labs'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 Micro Labs as present at those locations.

Country City Firm Name
India
Verna Micro Labs Limited
Bangalore Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bengaluru Micro Labs Limited





13. NAVINTA LLC

Navinta Llc has filed for 1 generic for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Navinta Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Discontinued INJECTION N/A Nov 17, 2009





14. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

capsule Discontinued ORAL N/A Jul 18, 1996
30MG

capsule Discontinued ORAL N/A Jul 18, 1996





15. RK PHARMA

Rk Pharma Inc has filed for 1 generic for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Rk Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Prescription INJECTION AP Nov 17, 2009


Manufacturing Plant Locations
New

Rk Pharma'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 Rk Pharma as present at those locations.

Country City Firm Name
United States
Pearl River RK Pharma Inc.





16. SENORES PHARMS

Senores Pharmaceuticals Inc has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Senores Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG

capsule Prescription ORAL AB Jul 17, 2023
20MG

capsule Prescription ORAL AB Jul 17, 2023





17. SKG PHARMA

Skg Pharma Inc has filed for 2 different strengths of generic version for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Skg Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG

capsule Prescription ORAL AB Apr 10, 2024
20MG

capsule Prescription ORAL AB Apr 10, 2024





18. WOCKHARDT

Wockhardt Ltd has filed for 1 generic for Nicardipine Hydrochloride. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/10ML (2.5MG/ML)

injectable Prescription INJECTION AP Nov 17, 2009


Manufacturing Plant Locations
New

Wockhardt'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 Wockhardt as present at those locations.

Country City Firm Name
India
Ankleshwar Wockhardt, Ltd.
Solan, Nalagarh Wockhardt Limited - Baddi
Aurangabad Wockhardt Limited