Methylphenidate Hydrochloride Patent Expiration

Methylphenidate Hydrochloride was first introduced by Sandoz Inc in its drug Ritalin on Approved Prior to Jan 1, 1982. Other drugs containing Methylphenidate Hydrochloride are Methylin, Relexxii, Adhansia Xr, Quillichew Er, Ritalin-Sr, Ritalin La, Quillivant Xr, Concerta, Jornay Pm, Metadate Cd, Aptensio Xr. 50 different companies have introduced drugs containing Methylphenidate Hydrochloride.


Methylphenidate Hydrochloride Patents

Given below is the list of patents protecting Methylphenidate 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
Adhansia Xr US10111839 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10292938 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10292939 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10449159 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10500162 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10507186 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10512612 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10512613 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10568841 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10688060 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Adhansia Xr US10722473 Methods and compositions particularly for treatment of attention deficit disorder Nov 19, 2038 Purdue Pharma Lp
Adhansia Xr US9974752 Methods and compositions particularly for treatment of attention deficit disorder Oct 30, 2035 Purdue Pharma Lp
Aptensio Xr US10039719 Methods of treating attention deficit hyperactivity disorder Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US10039719

(Pediatric)

Methods of treating attention deficit hyperactivity disorder Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US10463624 Controlled release formulations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US6419960 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US6419960

(Pediatric)

Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US7083808 Controlled/modified release oral methylphenidate formulations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US7083808

(Pediatric)

Controlled/modified release oral methylphenidate formulations Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US7247318 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US7247318

(Pediatric)

Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US7438930 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US7438930

(Pediatric)

Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US8580310 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US8580310

(Pediatric)

Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US9066869 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US9066869

(Pediatric)

Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Jun 16, 2020

(Expired)

Rhodes Pharms
Aptensio Xr US9801823 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Dec 16, 2019

(Expired)

Rhodes Pharms
Aptensio Xr US9801823

(Pediatric)

Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Jun 16, 2020

(Expired)

Rhodes Pharms
Concerta US6919373 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Concerta US6919373

(Pediatric)

Methods and devices for providing prolonged drug therapy Jan 31, 2018

(Expired)

Janssen Pharms
Concerta US6930129 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Concerta US6930129

(Pediatric)

Methods and devices for providing prolonged drug therapy Jan 31, 2018

(Expired)

Janssen Pharms
Concerta US8163798 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Concerta US8163798

(Pediatric)

Methods and devices for providing prolonged drug therapy Jan 31, 2018

(Expired)

Janssen Pharms
Concerta US8629179 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Concerta US8629179

(Pediatric)

Methods and devices for providing prolonged drug therapy Jan 31, 2018

(Expired)

Janssen Pharms
Concerta US9000038 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Concerta US9000038

(Pediatric)

Methods and devices for providing prolonged drug therapy Jan 31, 2018

(Expired)

Janssen Pharms
Concerta US9029416 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Concerta US9144549 Methods and devices for providing prolonged drug therapy Jul 31, 2017

(Expired)

Janssen Pharms
Jornay Pm US10182995 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US10292937 Methods of treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US10617651 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US10881618 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US10905652 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US11241391 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US11241392 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US11911518 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US8916588 Methods for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US8927010 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US9023389 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US9028868 Methods and compositions for treatment of attention deficit disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US9034902 Methods for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US9283214 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US9498447 Compositions for treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Jornay Pm US9603809 Methods of treatment of attention deficit hyperactivity disorder Mar 23, 2032 Ironshore Pharms
Metadate Cd US6344215 Methylphenidate modified release formulations Oct 27, 2020

(Expired)

Aytu Biopharma
Methylin US7691880 Methylphenidate solution and associated methods of administration and production Oct 07, 2024 Specgx Llc
Quillichew Er US10857143 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US11103494 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US11103495 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US11633389 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US8202537 Modified release formulations containing drug-ion exchange resin complexes Mar 15, 2027 Nextwave Pharms
Quillichew Er US8287903 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave Pharms
Quillichew Er US8999386 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US9295642 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US9545399 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillichew Er US9844544 Methylphenidate extended release chewable tablet Aug 14, 2033 Nextwave Pharms
Quillivant Xr US8062667 Modified release formulations containing drug-ion exchange resin complexes Mar 29, 2029 Nextwave
Quillivant Xr US8287903 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave
Quillivant Xr US8465765 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave
Quillivant Xr US8563033 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave
Quillivant Xr US8778390 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave
Quillivant Xr US8956649 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave
Quillivant Xr US9040083 Orally effective methylphenidate extended release powder and aqueous suspension product Feb 15, 2031 Nextwave
Ritalin La US5837284 Delivery of multiple doses of medications Dec 04, 2015

(Expired)

Sandoz
Ritalin La US6228398 Multiparticulate modified release composition Nov 01, 2019

(Expired)

Sandoz
Ritalin La US6635284 Delivery of multiple doses of medications Dec 04, 2015

(Expired)

Sandoz
Ritalin La US7431944 Delivery of multiple doses of medications Dec 04, 2015

(Expired)

Sandoz


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 Methylphenidate Hydrochloride's patents.

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

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jun, 2024 US9545399
Payment of Maintenance Fee, 4th Year, Large Entity 21 May, 2024 US10857143
Payment of Maintenance Fee, 12th Year, Large Entity 03 Apr, 2024 US8287903(Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 06 Dec, 2023 US8202537(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 13 Sep, 2023 US9295642
Mail Miscellaneous Communication to Applicant 27 Apr, 2023 US11633389
Electronic Review 27 Apr, 2023 US11633389
Email Notification 27 Apr, 2023 US11633389
Miscellaneous Communication to Applicant - No Action Count 25 Apr, 2023 US11633389
Patent Issue Date Used in PTA Calculation 25 Apr, 2023 US11633389



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Methylphenidate Hydrochloride Generics

Several generic applications have been filed for Methylphenidate Hydrochloride. The first generic version for Methylphenidate Hydrochloride was by Lannett Co Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Sun Pharmaceutical Industries Inc and was approved on Aug 25, 2023.

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


1. OXFORD PHARMS

Oxford Pharmaceuticals Llc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Oxford Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB Sep 23, 2014
5MG tablet Prescription ORAL AB Sep 23, 2014
10MG tablet Prescription ORAL AB Sep 23, 2014


2. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 1 generic for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet, extended release Discontinued ORAL N/A Dec 21, 2001


3. AUROLIFE PHARMA LLC

Aurolife Pharma Llc has filed for 7 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurolife Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
36MG tablet, extended release Prescription ORAL AB Oct 21, 2016
54MG tablet, extended release Prescription ORAL AB Oct 21, 2016
18MG tablet, extended release Prescription ORAL AB Oct 21, 2016
27MG tablet, extended release Prescription ORAL AB Oct 21, 2016
5MG tablet Discontinued ORAL N/A Oct 25, 2018
10MG tablet Discontinued ORAL N/A Oct 25, 2018
20MG tablet Discontinued ORAL N/A Oct 25, 2018


4. NOSTRUM LABS INC

Nostrum Laboratories Inc has filed for 4 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Mar 3, 2017
5MG tablet Discontinued ORAL N/A Mar 3, 2017
2.5MG tablet, chewable Discontinued ORAL N/A Jan 26, 2017
20MG tablet Discontinued ORAL N/A Mar 3, 2017


5. LANNETT CO INC

Lannett Co Inc has filed for 7 different strengths of generic version for Methylphenidate Hydrochloride. Out of these 10mg version comes by the name METADATE ER, 20mg version comes by the name METADATE ER. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet, extended release Discontinued ORAL N/A Oct 20, 1999
20MG tablet, extended release Discontinued ORAL N/A Jun 1, 1988
5MG tablet Discontinued ORAL N/A Approved Prior to Jan 1, 1982
18MG tablet, extended release Prescription ORAL BX Jul 9, 2013
27MG tablet, extended release Prescription ORAL BX Jul 9, 2013
36MG tablet, extended release Prescription ORAL BX Sep 23, 2013
54MG tablet, extended release Prescription ORAL BX Sep 23, 2013


6. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Methylphenidate Hydrochloride. 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
54MG tablet, extended release Discontinued ORAL N/A Jul 15, 2019
36MG tablet, extended release Discontinued ORAL N/A Jul 15, 2019


7. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 4 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
36MG tablet, extended release Discontinued ORAL N/A Feb 1, 2018
18MG tablet, extended release Discontinued ORAL N/A Feb 1, 2018
27MG tablet, extended release Discontinued ORAL N/A Feb 1, 2018
54MG tablet, extended release Discontinued ORAL N/A Feb 1, 2018


8. WES PHARMA INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML solution Prescription ORAL AA Oct 3, 2018
10MG/5ML solution Prescription ORAL AA Oct 3, 2018


9. ANDOR PHARMS

Andor Pharmaceuticals Llc has filed for 4 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Andor Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
36MG tablet, extended release Prescription ORAL AB Apr 24, 2019
54MG tablet, extended release Prescription ORAL AB Apr 24, 2019
27MG tablet, extended release Prescription ORAL AB Apr 24, 2019
18MG tablet, extended release Prescription ORAL AB Apr 24, 2019


10. OSMOTICA PHARM US

Osmotica Pharmaceutical Us Llc has filed for 5 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Osmotica Pharm Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
36MG tablet, extended release Prescription ORAL AB Jul 28, 2017
72MG

(reference standard)

tablet, extended release Prescription ORAL AB Jul 28, 2017
54MG tablet, extended release Prescription ORAL AB Jul 28, 2017
27MG tablet, extended release Prescription ORAL AB Jul 28, 2017
18MG tablet, extended release Prescription ORAL AB Jul 28, 2017


11. NOVEL LABS INC

Novel Laboratories Inc has filed for 6 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Nov 13, 2015
2.5MG tablet, chewable Discontinued ORAL N/A Feb 25, 2015
5MG tablet Prescription ORAL AB Nov 13, 2015
5MG/5ML solution Prescription ORAL AA Aug 14, 2015
10MG/5ML solution Prescription ORAL AA Aug 14, 2015
20MG tablet Prescription ORAL AB Nov 13, 2015


12. TRIS PHARMA INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/5ML solution Prescription ORAL AA Jul 23, 2010
5MG/5ML solution Prescription ORAL AA Jul 23, 2010


13. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 8 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB Mar 15, 2012
5MG tablet Prescription ORAL AB Mar 15, 2012
10MG tablet Prescription ORAL AB Mar 15, 2012
36MG tablet, extended release Prescription ORAL AB Aug 19, 2020
18MG tablet, extended release Prescription ORAL AB Aug 19, 2020
27MG tablet, extended release Prescription ORAL AB Aug 19, 2020
54MG tablet, extended release Prescription ORAL AB Aug 19, 2020
72MG tablet, extended release Prescription ORAL AB Aug 25, 2023


14. QUAGEN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/5ML solution Prescription ORAL AA Jun 4, 2020
5MG/5ML solution Prescription ORAL AA Jun 4, 2020


15. PATRIN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/5ML solution Prescription ORAL AA Apr 10, 2020
5MG/5ML solution Prescription ORAL AA Apr 10, 2020


16. ABHAI LLC

Abhai Llc has filed for 4 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Abhai Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet, extended release Prescription ORAL AB Jun 9, 2015
20MG

(reference standard)

tablet, extended release Prescription ORAL AB Jun 9, 2015
5MG/5ML solution Prescription ORAL AA Nov 18, 2016
10MG/5ML solution Prescription ORAL AA Nov 18, 2016


17. ACTAVIS LABS FL

Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Methylphenidate Hydrochloride. 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
54MG tablet, extended release Prescription ORAL AB Mar 21, 2018
36MG tablet, extended release Prescription ORAL AB Mar 22, 2018
27MG tablet, extended release Prescription ORAL AB Mar 22, 2018
18MG tablet, extended release Prescription ORAL AB Mar 22, 2018
72MG tablet, extended release Prescription ORAL AB Feb 28, 2022


18. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. 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
5MG tablet Discontinued ORAL N/A Aug 29, 1997
10MG tablet Discontinued ORAL N/A Aug 29, 1997
20MG tablet, extended release Discontinued ORAL N/A Feb 9, 2001


19. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 5 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG capsule, extended release Prescription ORAL AB1 Dec 1, 2011
30MG capsule, extended release Prescription ORAL AB1 Dec 1, 2011
20MG capsule, extended release Prescription ORAL AB1 Dec 1, 2011
60MG

(reference standard)

capsule, extended release Prescription ORAL AB1 Jun 23, 2016
10MG capsule, extended release Prescription ORAL AB1 Feb 26, 2018


20. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 8 different strengths of generic version for Methylphenidate Hydrochloride. 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
10MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018
5MG tablet Discontinued ORAL N/A Feb 5, 2002
20MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018
30MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018
15MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018
40MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018
50MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018
60MG capsule, extended release Prescription ORAL AB3 Dec 13, 2018


21. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. 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
10MG tablet Prescription ORAL AB Oct 28, 2020
5MG tablet Prescription ORAL AB Oct 28, 2020
20MG tablet Prescription ORAL AB Oct 28, 2020


22. SPECGX LLC

Specgx Llc has filed for 10 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Specgx Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Nov 27, 1998
20MG capsule, extended release Prescription ORAL AB2 Sep 29, 2015
10MG capsule, extended release Prescription ORAL AB2 Sep 29, 2015
54MG tablet, extended release Prescription ORAL BX Dec 28, 2012
27MG tablet, extended release Prescription ORAL BX Dec 28, 2012
36MG tablet, extended release Prescription ORAL BX Dec 28, 2012
40MG capsule, extended release Prescription ORAL AB2 Sep 29, 2015
50MG capsule, extended release Prescription ORAL AB2 Sep 29, 2015
60MG capsule, extended release Prescription ORAL AB2 Sep 29, 2015
30MG capsule, extended release Prescription ORAL AB2 Sep 29, 2015


23. BIONPHARMA

Bionpharma Inc has filed for 3 different strengths of generic version for Methylphenidate 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
5MG tablet Prescription ORAL AB Mar 2, 2018
20MG tablet Prescription ORAL AB Mar 2, 2018
10MG tablet Prescription ORAL AB Mar 2, 2018


24. ABLE

Able Laboratories Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Able.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Discontinued ORAL N/A Mar 29, 2001
10MG tablet Discontinued ORAL N/A Mar 29, 2001
20MG tablet, extended release Discontinued ORAL N/A May 9, 2001


25. MOUNTAIN

Mountain Llc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Mountain.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB Mar 12, 2014
5MG tablet Prescription ORAL AB Mar 12, 2014
10MG tablet Prescription ORAL AB Mar 12, 2014


26. ASCENT PHARMS INC

Ascent Pharmaceuticals Inc has filed for 10 different strengths of generic version for Methylphenidate Hydrochloride. 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
5MG tablet, chewable Prescription ORAL AB Dec 29, 2017
20MG tablet Prescription ORAL AB Sep 22, 2015
10MG

(reference standard)

tablet, chewable Prescription ORAL AB Dec 29, 2017
2.5MG tablet, chewable Prescription ORAL AB Dec 29, 2017
18MG tablet, extended release Prescription ORAL AB Sep 3, 2019
27MG tablet, extended release Prescription ORAL AB Sep 3, 2019
36MG tablet, extended release Prescription ORAL AB Sep 3, 2019
54MG tablet, extended release Prescription ORAL AB Sep 3, 2019
10MG/5ML solution Prescription ORAL AA Jan 29, 2021
5MG/5ML solution Prescription ORAL AA Jan 29, 2021


27. ALVOGEN

Alvogen Inc has filed for 7 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Alvogen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Sep 15, 2016
20MG tablet Discontinued ORAL N/A Sep 15, 2016
5MG tablet Discontinued ORAL N/A Sep 15, 2016
18MG tablet, extended release Discontinued ORAL N/A Nov 30, 2018
54MG tablet, extended release Discontinued ORAL N/A Nov 30, 2018
36MG tablet, extended release Discontinued ORAL N/A Nov 30, 2018
27MG tablet, extended release Discontinued ORAL N/A Nov 30, 2018


28. CEDIPROF INC

Cediprof Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Cediprof Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Feb 1, 2019
20MG tablet Prescription ORAL AB Feb 1, 2019
5MG tablet Prescription ORAL AB Feb 1, 2019


29. IMPAX LABS INC

Impax Laboratories Inc has filed for 6 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG capsule, extended release Prescription ORAL AB2 Jul 28, 2016
10MG capsule, extended release Prescription ORAL AB2 Jul 28, 2016
20MG capsule, extended release Prescription ORAL AB2 Jul 28, 2016
30MG capsule, extended release Prescription ORAL AB2 Jul 28, 2016
40MG capsule, extended release Prescription ORAL AB2 Jul 28, 2016
50MG capsule, extended release Prescription ORAL AB2 Jul 28, 2016


30. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jul 23, 2020
20MG tablet Prescription ORAL AB Jul 23, 2020
5MG tablet Prescription ORAL AB Jul 23, 2020


31. RHODES PHARMS

Rhodes Pharmaceuticals Lp has filed for 4 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Rhodes Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
18MG tablet, extended release Discontinued ORAL N/A May 31, 2022
27MG tablet, extended release Discontinued ORAL N/A May 31, 2022
36MG tablet, extended release Discontinued ORAL N/A May 31, 2022
54MG tablet, extended release Discontinued ORAL N/A May 31, 2022


32. ABHAI INC

Abhai Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Abhai Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB May 11, 2017
5MG tablet Prescription ORAL AB May 11, 2017
20MG tablet Prescription ORAL AB May 11, 2017


33. DR REDDYS

Dr Reddys Laboratories Inc has filed for 4 different strengths of generic version for Methylphenidate Hydrochloride. 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
36MG tablet, extended release Prescription ORAL AB Jul 29, 2020
18MG tablet, extended release Prescription ORAL AB Jul 29, 2020
27MG tablet, extended release Prescription ORAL AB Jul 29, 2020
54MG tablet, extended release Prescription ORAL AB Jul 29, 2020


34. RISING

Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet, chewable Prescription ORAL AB Nov 7, 2016
10MG tablet, chewable Prescription ORAL AB Nov 7, 2016
5MG tablet, chewable Prescription ORAL AB Nov 7, 2016


35. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 4 different strengths of generic version for Methylphenidate 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
54MG tablet, extended release Discontinued ORAL N/A Jul 14, 2017
18MG tablet, extended release Discontinued ORAL N/A Jul 14, 2017
36MG tablet, extended release Discontinued ORAL N/A Jul 14, 2017
27MG tablet, extended release Discontinued ORAL N/A Jul 14, 2017


36. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 2 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML solution Discontinued ORAL N/A Dec 16, 2020
10MG/5ML solution Discontinued ORAL N/A Dec 16, 2020


37. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 6 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG capsule, extended release Prescription ORAL AB2 Jul 19, 2012
30MG capsule, extended release Prescription ORAL AB2 Jul 19, 2012
20MG capsule, extended release Prescription ORAL AB2 Jul 19, 2012
10MG capsule, extended release Prescription ORAL AB2 Jul 19, 2012
40MG capsule, extended release Prescription ORAL AB2 Jul 19, 2012
50MG capsule, extended release Prescription ORAL AB2 Jul 19, 2012


38. BARR LABS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG capsule, extended release Discontinued ORAL N/A Jul 13, 2012
30MG capsule, extended release Discontinued ORAL N/A Jul 13, 2012
40MG capsule, extended release Discontinued ORAL N/A Jul 13, 2012
10MG capsule, extended release Discontinued ORAL N/A Oct 15, 2014


39. BRECKENRIDGE

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML solution Discontinued ORAL N/A Nov 12, 2013
10MG/5ML solution Discontinued ORAL N/A Nov 12, 2013


40. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 9 different strengths of generic version for Methylphenidate Hydrochloride. 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
10MG tablet Prescription ORAL AB Oct 4, 2019
20MG tablet, extended release Prescription ORAL AB Oct 6, 2020
5MG tablet Prescription ORAL AB Oct 4, 2019
5MG/5ML solution Prescription ORAL AA Mar 30, 2020
10MG/5ML solution Prescription ORAL AA Mar 30, 2020
27MG tablet, extended release Prescription ORAL AB May 23, 2023
36MG tablet, extended release Prescription ORAL AB May 23, 2023
54MG tablet, extended release Prescription ORAL AB May 23, 2023
18MG tablet, extended release Prescription ORAL AB May 23, 2023


41. GRANULES

Granules Pharmaceuticals Inc has filed for 5 different strengths of generic version for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG capsule, extended release Prescription ORAL AB1 May 23, 2019
10MG capsule, extended release Prescription ORAL AB1 May 23, 2019
40MG capsule, extended release Prescription ORAL AB1 May 23, 2019
30MG capsule, extended release Prescription ORAL AB1 May 23, 2019
60MG capsule, extended release Prescription ORAL AB1 May 23, 2019


42. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Methylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/ML for suspension, extended release Prescription ORAL AB May 17, 2018