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. 26 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
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


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Ranolazine Generics

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 Novast Laboratories Ltd and was approved on Sep 27, 2023.

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


1. 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
500MG tablet, extended release Prescription ORAL AB May 5, 2022
1GM tablet, extended release Prescription ORAL AB May 5, 2022


2. 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
1GM tablet, extended release Prescription ORAL AB May 28, 2019
500MG tablet, extended release Prescription ORAL AB May 28, 2019


3. 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
500MG tablet, extended release Prescription ORAL AB Jan 28, 2021
1GM tablet, extended release Prescription ORAL AB Jan 28, 2021


4. 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
500MG tablet, extended release Discontinued ORAL N/A Oct 29, 2019
1GM tablet, extended release Discontinued ORAL N/A Oct 29, 2019


5. 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


6. 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
500MG tablet, extended release Prescription ORAL AB Mar 23, 2020
1GM tablet, extended release Prescription ORAL AB Mar 23, 2020


7. PIRAMAL HLTHCARE UK

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 Hlthcare Uk.

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


8. 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

(reference standard)

tablet, extended release Prescription ORAL AB May 28, 2019
500MG tablet, extended release Prescription ORAL AB May 28, 2019


9. 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
1GM tablet, extended release Prescription ORAL AB Sep 27, 2023
500MG tablet, extended release Prescription ORAL AB Sep 27, 2023


10. 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
500MG tablet, extended release Discontinued ORAL N/A Mar 11, 2021
1GM tablet, extended release Discontinued ORAL N/A Mar 11, 2021


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


12. 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


13. 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
500MG tablet, extended release Prescription ORAL AB Jan 19, 2022
1GM tablet, extended release Prescription ORAL AB Jan 19, 2022


14. 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 tablet, extended release Prescription ORAL AB Aug 19, 2019


15. 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


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
500MG tablet, extended release Prescription ORAL AB Feb 12, 2020
1GM tablet, extended release Prescription ORAL AB Feb 12, 2020


17. 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


18. PRAXGEN

Praxgen 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 Praxgen.

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


19. 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


20. 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
1GM tablet, extended release Prescription ORAL AB Dec 23, 2022
500MG tablet, extended release Prescription ORAL AB Dec 23, 2022


21. 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
1GM tablet, extended release Prescription ORAL AB Nov 30, 2020
500MG tablet, extended release Prescription ORAL AB Nov 30, 2020


22. 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
1GM tablet, extended release Prescription ORAL AB Jun 4, 2019
500MG tablet, extended release Prescription ORAL AB Jun 4, 2019


23. 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
1GM tablet, extended release Prescription ORAL AB Mar 16, 2023
500MG tablet, extended release Prescription ORAL AB Mar 16, 2023


24. 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
1GM tablet, extended release Prescription ORAL AB Feb 27, 2020
500MG tablet, extended release Prescription ORAL AB Feb 27, 2020