Topiramate Patent Expiration

Topiramate is Used for preventing migraines in patients 12 years and older. It was first introduced by Janssen Pharmaceuticals Inc in its drug Topamax on Dec 24, 1996. Other drugs containing Topiramate are Qudexy Xr, Trokendi Xr, Topamax Sprinkle, Eprontia. 38 different companies have introduced drugs containing Topiramate.


Topiramate Patents

Given below is the list of patents protecting Topiramate, 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
Eprontia US11433046 Compositions and methods for treating epilepsy, seizures and other conditions Aug 21, 2040 Azurity
Eprontia US11633374 Compositions and methods for treating epilepsy, seizures and other conditions Aug 21, 2040 Azurity
Eprontia US11826343 Compositions and methods for treating epilepsy, seizures and other conditions Aug 21, 2040 Azurity
Eprontia US11911362 Compositions and methods for treating epilepsy, seizures and other conditions Aug 21, 2040 Azurity
Qudexy Xr US10363224 Extended-release topiramate capsules Mar 19, 2033 Upsher Smith Labs
Qudexy Xr US8652527 Extended-release topiramate capsules Mar 19, 2033 Upsher Smith Labs
Qudexy Xr US8889190 Extended-release topiramate capsules Mar 19, 2033 Upsher Smith Labs
Qudexy Xr US9101545 Extended-release topiramate capsules Mar 19, 2033 Upsher Smith Labs
Qudexy Xr US9555005 Extended-release topiramate capsules Mar 19, 2033 Upsher Smith Labs
Topamax US5998380 Treatment of migraine Oct 13, 2015

(Expired)

Janssen Pharms
Topamax US5998380

(Pediatric)

Treatment of migraine Apr 13, 2016

(Expired)

Janssen Pharms
Topamax US6503884 Migraine treatment method using topiramate and related compounds Oct 13, 2015

(Expired)

Janssen Pharms
Topamax US6503884

(Pediatric)

Migraine treatment method using topiramate and related compounds Apr 13, 2016

(Expired)

Janssen Pharms
Topamax US7018983 Treatment of migraine Oct 13, 2015

(Expired)

Janssen Pharms
Topamax US7018983

(Pediatric)

Treatment of migraine Apr 13, 2016

(Expired)

Janssen Pharms
Topamax US7125560 Pharmaceutical composition of topiramate Mar 01, 2019

(Expired)

Janssen Pharms
Topamax US7125560

(Pediatric)

Pharmaceutical composition of topiramate Sep 01, 2019

(Expired)

Janssen Pharms
Topamax US7498311 Treatment of migraine Oct 13, 2015

(Expired)

Janssen Pharms
Topamax US7498311

(Pediatric)

Treatment of migraine Apr 13, 2016

(Expired)

Janssen Pharms
Topamax Sprinkle US5998380 Treatment of migraine Oct 13, 2015

(Expired)

Janssen Pharms
Topamax Sprinkle US5998380

(Pediatric)

Treatment of migraine Apr 13, 2016

(Expired)

Janssen Pharms
Topamax Sprinkle US6503884 Migraine treatment method using topiramate and related compounds Oct 13, 2015

(Expired)

Janssen Pharms
Topamax Sprinkle US6503884

(Pediatric)

Migraine treatment method using topiramate and related compounds Apr 13, 2016

(Expired)

Janssen Pharms
Topamax Sprinkle US7018983 Treatment of migraine Oct 13, 2015

(Expired)

Janssen Pharms
Topamax Sprinkle US7018983

(Pediatric)

Treatment of migraine Apr 13, 2016

(Expired)

Janssen Pharms
Topamax Sprinkle US7125560 Pharmaceutical composition of topiramate Mar 01, 2019

(Expired)

Janssen Pharms
Topamax Sprinkle US7125560

(Pediatric)

Pharmaceutical composition of topiramate Sep 01, 2019

(Expired)

Janssen Pharms
Topamax Sprinkle US7498311 Treatment of migraine Oct 13, 2015

(Expired)

Janssen Pharms
Topamax Sprinkle US7498311

(Pediatric)

Treatment of migraine Apr 13, 2016

(Expired)

Janssen Pharms
Trokendi Xr US10314790 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US8298576 Sustained-release formulations of topiramate Apr 04, 2028 Supernus Pharms
Trokendi Xr US8298580 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US8663683 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US8877248 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US8889191 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US8992989 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US9549940 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US9555004 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms
Trokendi Xr US9622983 Sustained-release formulations of topiramate Nov 16, 2027 Supernus Pharms


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 Topiramate's patents.

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

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 30 Apr, 2024 US8298580(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 13 Feb, 2023 US9101545
Payment of Maintenance Fee, 4th Year, Large Entity 30 Jan, 2023 US10363224
Payment of Maintenance Fee, 4th Year, Large Entity 12 Dec, 2022 US10314790(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 18 May, 2022 US8889191(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 18 May, 2022 US8889190
Payment of Maintenance Fee, 8th Year, Large Entity 04 May, 2022 US8877248
Payment of Maintenance Fee, 8th Year, Large Entity 18 Aug, 2021 US8652527(Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 19 Oct, 2020 US9622983(Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 31 Jul, 2020 US9555004(Litigated)



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Topiramate Generics

Several generic applications have been filed for Topiramate. The first generic version for Topiramate was by Mylan Pharmaceuticals Inc and was approved on Mar 27, 2009. And the latest generic version is by Alkem Laboratories Ltd and was approved on Jun 13, 2024.

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


1. INVAGEN PHARMS

Invagen Pharmaceuticals Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Invagen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
100MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Mar 27, 2009


2. BARR

Barr Laboratories Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Discontinued ORAL N/A Apr 15, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009
15MG capsule Discontinued ORAL N/A Apr 15, 2009


3. TEVA

Teva Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB Apr 17, 2009
50MG tablet Discontinued ORAL N/A Mar 27, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009
15MG capsule Prescription ORAL AB Apr 17, 2009


4. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB Oct 14, 2009
15MG capsule Prescription ORAL AB Oct 14, 2009


5. CIPLA LTD

Cipla Ltd has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Cipla Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
100MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Mar 27, 2009


6. FOSUN PHARMA

Fosun Pharma Usa Inc has filed for 2 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Fosun Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MG capsule Discontinued ORAL N/A Oct 14, 2009
25MG capsule Discontinued ORAL N/A Oct 14, 2009


7. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Topiramate. 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
25MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
100MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Mar 27, 2009


8. HIKMA PHARMS

Hikma Pharmaceuticals has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Hikma Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Discontinued ORAL N/A Nov 25, 2013
100MG tablet Discontinued ORAL N/A Nov 25, 2013
50MG tablet Discontinued ORAL N/A Nov 25, 2013
25MG tablet Discontinued ORAL N/A Nov 25, 2013


9. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Mar 27, 2009
25MG capsule Prescription ORAL AB Oct 14, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
15MG capsule Prescription ORAL AB Oct 14, 2009


10. TORRENT PHARMS

Torrent Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Torrent Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Mar 27, 2009
50MG tablet Discontinued ORAL N/A Mar 27, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009


11. ACTAVIS LABS FL

Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG capsule, extended release Prescription ORAL AB1 Mar 10, 2023
25MG capsule, extended release Prescription ORAL AB1 Mar 10, 2023
200MG capsule, extended release Prescription ORAL AB1 Mar 10, 2023
100MG capsule, extended release Prescription ORAL AB1 Mar 10, 2023


12. WATSON LABS

Watson Laboratories Inc has filed for 5 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Discontinued ORAL N/A Apr 15, 2009
50MG tablet Discontinued ORAL N/A Mar 27, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009
15MG capsule Discontinued ORAL N/A Apr 15, 2009


13. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Mar 27, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009


14. ZYDUS

Zydus Worldwide Dmcc has filed for 5 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Zydus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule, extended release Prescription ORAL AB2 Nov 29, 2022
25MG capsule, extended release Prescription ORAL AB2 Nov 29, 2022
50MG capsule, extended release Prescription ORAL AB2 Nov 29, 2022
150MG capsule, extended release Prescription ORAL AB2 Nov 29, 2022
200MG capsule, extended release Prescription ORAL AB1 Oct 30, 2023


15. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Topiramate. 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
200MG capsule, extended release Discontinued ORAL N/A Feb 9, 2023


16. VIWIT PHARM

Viwit Pharmaceutical Co Ltd has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Viwit Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
100MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Mar 27, 2009


17. WOCKHARDT

Wockhardt Ltd has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Discontinued ORAL N/A Sep 1, 2010
25MG tablet Discontinued ORAL N/A Sep 1, 2010
50MG tablet Discontinued ORAL N/A Sep 1, 2010
200MG tablet Discontinued ORAL N/A Sep 1, 2010


18. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 4 different strengths of generic version for Topiramate. 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
25MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
100MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Mar 27, 2009


19. TWI PHARMS

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG capsule Prescription ORAL AB Dec 5, 2023
15MG capsule Prescription ORAL AB Dec 5, 2023


20. ROXANE

Roxane Laboratories Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Roxane.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Mar 27, 2009
50MG tablet Discontinued ORAL N/A Mar 27, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009


21. CHARTWELL

Chartwell Life Molecules Llc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Chartwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Discontinued ORAL N/A Sep 11, 2013
50MG tablet Discontinued ORAL N/A Sep 11, 2013
25MG tablet Discontinued ORAL N/A Sep 11, 2013
200MG tablet Discontinued ORAL N/A Sep 11, 2013


22. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 4 different strengths of generic version for Topiramate. 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
100MG capsule, extended release Discontinued ORAL N/A Aug 15, 2023
200MG capsule, extended release Discontinued ORAL N/A Aug 15, 2023
25MG capsule, extended release Discontinued ORAL N/A Aug 15, 2023
50MG capsule, extended release Discontinued ORAL N/A Aug 15, 2023


23. ASCENT PHARMS INC

Ascent Pharmaceuticals Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Aug 26, 2021
25MG tablet Prescription ORAL AB Aug 26, 2021
200MG tablet Prescription ORAL AB Aug 26, 2021
100MG tablet Prescription ORAL AB Aug 26, 2021


24. ACTAVIS TOTOWA

Actavis Totowa Llc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Actavis Totowa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Feb 27, 2013
50MG tablet Discontinued ORAL N/A Feb 27, 2013
100MG tablet Discontinued ORAL N/A Feb 27, 2013
200MG tablet Discontinued ORAL N/A Feb 27, 2013


25. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Topiramate. 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
25MG capsule, extended release Prescription ORAL AB2 Feb 1, 2021
50MG capsule, extended release Prescription ORAL AB2 Feb 1, 2021
100MG capsule, extended release Prescription ORAL AB2 Feb 1, 2021
200MG capsule, extended release Prescription ORAL AB2 Feb 1, 2021
150MG capsule, extended release Prescription ORAL AB2 Feb 1, 2021


26. AIPING PHARM INC

Aiping Pharmaceutical Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Aiping Pharm Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Discontinued ORAL N/A Jan 7, 2010
100MG tablet Discontinued ORAL N/A Jan 7, 2010
50MG tablet Discontinued ORAL N/A Jan 7, 2010
25MG tablet Discontinued ORAL N/A Jan 7, 2010


27. MYLAN

Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Mar 27, 2009
50MG tablet Discontinued ORAL N/A Mar 27, 2009
100MG tablet Discontinued ORAL N/A Mar 27, 2009
200MG tablet Discontinued ORAL N/A Mar 27, 2009


28. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Topiramate. 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
100MG capsule, extended release Prescription ORAL AB1 Nov 17, 2023
200MG capsule, extended release Prescription ORAL AB1 Nov 17, 2023
50MG capsule, extended release Prescription ORAL AB1 Nov 17, 2023
25MG capsule, extended release Prescription ORAL AB1 Nov 17, 2023


29. AUROBINDO PHARMA LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MG capsule Prescription ORAL AB Sep 27, 2023
25MG capsule Prescription ORAL AB Sep 27, 2023


30. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Topiramate. 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
200MG tablet Prescription ORAL AB Mar 27, 2009
100MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
25MG tablet Prescription ORAL AB Mar 27, 2009


31. ENDO OPERATIONS

Endo Operations Ltd has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG capsule, extended release Prescription ORAL AB1 Mar 1, 2023
100MG capsule, extended release Prescription ORAL AB1 May 4, 2023
50MG capsule, extended release Prescription ORAL AB1 May 4, 2023
25MG capsule, extended release Prescription ORAL AB1 May 4, 2023


32. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 5 different strengths of generic version for Topiramate. 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
25MG capsule Prescription ORAL AB Jun 13, 2024
200MG capsule, extended release Prescription ORAL AB1 Jun 20, 2023
100MG capsule, extended release Prescription ORAL AB1 Jun 20, 2023
50MG capsule, extended release Prescription ORAL AB1 Jun 20, 2023
15MG capsule Prescription ORAL AB Jun 13, 2024


33. PLIVA HRVATSKA DOO

Pliva Hrvatska Doo has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Pliva Hrvatska Doo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG tablet Discontinued ORAL N/A Mar 30, 2009
100MG tablet Discontinued ORAL N/A Mar 30, 2009
50MG tablet Discontinued ORAL N/A Mar 30, 2009
200MG tablet Discontinued ORAL N/A Mar 30, 2009


34. UNICHEM LABS LTD

Unichem Laboratories Ltd has filed for 4 different strengths of generic version for Topiramate. Given below are the details of the strengths of this generic introduced by Unichem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Prescription ORAL AB Mar 27, 2009
50MG tablet Prescription ORAL AB Mar 27, 2009
25MG tablet Prescription ORAL AB Mar 27, 2009
200MG tablet Prescription ORAL AB Feb 19, 2013