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Ranolazine Patent Expiration

Ranolazine was first introduced by Menarini International Operations Luxembourg Sa in its drug Ranexa on Jan 27, 2006. Another drug containing Ranolazine is Aspruzyo Sprinkle. 28 different companies have introduced drugs containing Ranolazine.


Ranolazine Patents

Given below is the list of patents protecting Ranolazine, 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
Aspruzyo Sprinkle US10898444 Extended release multiparticulates of ranolazine Jan 24, 2038 Spil
Aspruzyo Sprinkle US11510878 Extended release multiparticulates of ranolazine Jan 24, 2038 Spil
Aspruzyo Sprinkle US12161761 Extended release multiparticulates of ranolazine Jan 24, 2038 Spil
Ranexa US6303607 Method for administering a sustained release ranolanolazine formulation May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6369062 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6479496 Methods for treating angina with ranolazine May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6503911 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6525057 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6562826 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6617328 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6620814 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6852724 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl
Ranexa US6864258 Sustained release ranolazine formulations May 27, 2019

(Expired)

 Menarini Intl



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 Ranolazine's patents.

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

Activity Date Patent Number
Patent litigations
File Marked Found 20 Dec, 2016 US6620814(Litigated)
File Marked Found 15 Dec, 2016 US6525057(Litigated)
File Marked Found 12 Dec, 2016 US6525057(Litigated)
Post Issue Communication - Certificate of Correction 11 Aug, 2015 US6562826(Litigated)
Case Docketed to Examiner in GAU
Critical
 05 Aug, 2015 US6562826(Litigated)
Post Issue Communication - Certificate of Correction 19 Mar, 2015 US6620814(Litigated)
Post Issue Communication - Certificate of Correction 21 Jan, 2015 US6852724(Litigated)
Correspondence Address Change
Critical
 01 Mar, 2012 US6525057(Litigated)
Correspondence Address Change
Critical
 01 Mar, 2012 US6562826(Litigated)
Correspondence Address Change
Critical
 01 Mar, 2012 US6503911(Litigated)


Ranolazine's Family Patents

Family Patents

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Ranolazine Generic API Manufacturers

Several generic applications have been filed for Ranolazine. The first generic version for Ranolazine was by Chartwell Rx Sciences Llc and was approved on Jul 29, 2013. And the latest generic version is by Jubilant Generics Ltd and was approved on Apr 15, 2025.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Discontinued ORAL N/A May 18, 2021
500MG

tablet, extended release Discontinued ORAL N/A May 18, 2021





2. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB May 28, 2019
1GM

tablet, extended release Prescription ORAL AB May 28, 2019


Manufacturing Plant Locations
New

Actavis Elizabeth'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 Actavis Elizabeth as present at those locations.

Country City Firm Name
United States
Elizabeth Actavis Elizabeth LLC, A Company of Teva





3. AJANTA PHARMA LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB May 28, 2019
1GM

tablet, extended release Prescription ORAL AB May 28, 2019


Manufacturing Plant Locations
New

Ajanta Pharma Ltd'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 Ajanta Pharma Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Ajanta Pharma Ltd.





4. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Nov 30, 2020
1GM

tablet, extended release Prescription ORAL AB Nov 30, 2020





5. AMNEAL

Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Discontinued ORAL N/A Mar 11, 2021
500MG

tablet, extended release Discontinued ORAL N/A Mar 11, 2021


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





6. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ranolazine. 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
1GM

tablet, extended release Discontinued ORAL N/A Oct 29, 2019
500MG

tablet, extended release Discontinued ORAL N/A Oct 29, 2019





7. ARTHUR GRP

Arthur Group Llc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Arthur Grp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Mar 23, 2020
1GM

tablet, extended release Prescription ORAL AB Mar 23, 2020





8. AUROBINDO PHARMA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Dec 23, 2022
1GM

tablet, extended release Prescription ORAL AB Dec 23, 2022


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd
Bachupally Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





9. CADILA

Cadila Healthcare Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Cadila.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Aug 19, 2019
1GM

(reference standard)

tablet, extended release Prescription ORAL AB Aug 19, 2019


Manufacturing Plant Locations
New

Cadila'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 Cadila as present at those locations.

Country City Firm Name
United States
Pennington Cadila Healthcare Limited
India
Ankleshwar Cadila Pharmaceuticals Limited
Ahmedabad Cadila Pharmaceuticals Limited





10. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Jul 29, 2013
1GM

tablet, extended release Prescription ORAL AB Jul 29, 2013





11. CIPLA

Cipla Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Discontinued ORAL N/A May 28, 2019
1GM

tablet, extended release Discontinued ORAL N/A May 28, 2019


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
Raigad Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Pithampur, District Dhar Cipla Limited
Vasco Da Gama Cipla Limited
Bengaluru Cipla Limited
Mumbai Cipla Limited
Bangalore Cipla Ltd.





12. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Ranolazine. 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
1GM

tablet, extended release Prescription ORAL AB Jul 5, 2019
500MG

tablet, extended release Prescription ORAL AB Jul 5, 2019





13. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Prescription ORAL AB May 5, 2022
500MG

tablet, extended release Prescription ORAL AB May 5, 2022





14. I3 PHARMS

I3 Pharmaceuticals Llc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by I3 Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Apr 27, 2022
1GM

tablet, extended release Prescription ORAL AB Apr 27, 2022





15. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Jubilant Generics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Prescription ORAL AB Apr 15, 2025
500MG

tablet, extended release Prescription ORAL AB Apr 15, 2025


Manufacturing Plant Locations
New

Jubilant Generics'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 Jubilant Generics as present at those locations.

Country City Firm Name
India
Roorkee Jubilant Generics Limited





16. MANKIND PHARMA

Mankind Pharma Ltd has filed for 2 different strengths of generic version for Ranolazine. 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
1GM

tablet, extended release Prescription ORAL AB Feb 12, 2020
500MG

tablet, extended release Prescription ORAL AB Feb 12, 2020


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
Imt Manesar Mankind Pharma Limited
Paonta Sahib Mankind Pharma Limited





17. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Ranolazine. 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
500MG

tablet, extended release Prescription ORAL AB Feb 27, 2020
1GM

tablet, extended release Prescription ORAL AB Feb 27, 2020


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
Bangalore Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Verna Micro Labs Limited





18. NOVAST LABS

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Sep 27, 2023
1GM

tablet, extended release Prescription ORAL AB Sep 27, 2023





19. PIRAMAL

Piramal Healthcare Uk Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Piramal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Discontinued ORAL N/A Jul 25, 2023
1GM

tablet, extended release Discontinued ORAL N/A Jul 25, 2023





20. RISING

Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Prescription ORAL AB Jan 28, 2021
500MG

tablet, extended release Prescription ORAL AB Jan 28, 2021


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





21. SCIEGEN PHARMS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Jun 4, 2019
1GM

tablet, extended release Prescription ORAL AB Jun 4, 2019





22. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Ranolazine. 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
1GM

tablet, extended release Discontinued ORAL N/A May 28, 2019
500MG

tablet, extended release Discontinued ORAL N/A May 28, 2019


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





23. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Prescription ORAL AB Mar 23, 2020
500MG

tablet, extended release Prescription ORAL AB Mar 23, 2020


Manufacturing Plant Locations
New

Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.

Country City Firm Name
United States
Andrews Sunshine Dairy, LLC
Rochester Sunshine Fund Raising Co.
Dublin Sunshine Mills, Inc
Artesia Sunshine Evergreen Inc.
Glenwood Springs Sunshine & Moons, LLC
Methuen Sunshine International Foods, Inc.
Augusta Sunshine Honey Inc.
Tupelo Sunshine Mills, Inc.
Bridgeville Sunshine Burger & Specialty Food Company, LLC
Indianapolis SUNSHINE INTERNATIONAL LLC
Halifax Sunshine Mills, Inc.
Portland Sunshine Dairy Foods Management LLC
Red Bay Sunshine Mills aka World Pet Care
North Las Vegas Sunshine Fresh Nevada LLC
Columbus Sunshine Apiaries
Doral Sunshine Bottling Co, Inc.
Alhambra Sunshine Bakery
Evergreen Sunshine Honey Bees LLC
Jacksonville Sunshine Peanut Company
Maumee Sunshine Inc Of Nw Ohio
Peru
Tambogrande Sunshine Export S.A.C
India
Surat Sunshine Global Hospital
Thailand
Tha Mai Sunshine International
China
Dongguan Sunshine Lake Pharma Co., Ltd
Mozambique
Boane Sunshine Nut Limitada





24. TORRENT

Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Prescription ORAL AB Feb 4, 2025
500MG

tablet, extended release Prescription ORAL AB Feb 4, 2025


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Bharuch Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





25. UNICHEM

Unichem Laboratories Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet, extended release Prescription ORAL AB Mar 16, 2023
1GM

tablet, extended release Prescription ORAL AB Mar 16, 2023


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Pithampur Unichem Laboratories Limited
Pilerne Bardez Unichem Laboratories Limited
Kolhapur Unichem Laboratories Limited
Mumbai Unichem Laboratories Limited
District Raigad Unichem Laboratories Ltd
Ghaziabad Unichem Laboratories Ltd.
United States
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc
East Brunswick Unichem Pharmaceuticals USA Inc.





26. VKT PHARMA

Vkt Pharma Private Ltd has filed for 2 different strengths of generic version for Ranolazine. Given below are the details of the strengths of this generic introduced by Vkt Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

tablet, extended release Prescription ORAL AB Jan 19, 2022
500MG

tablet, extended release Prescription ORAL AB Jan 19, 2022


Manufacturing Plant Locations
New

Vkt 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 Vkt Pharma as present at those locations.

Country City Firm Name
India
Srikakulam VKT Pharma Private Limited