Risperidone Patent Expiration

Risperidone is used for treating various conditions such as depression, anxiety, and obsessive-compulsive disorder. It was first introduced by Janssen Pharmaceuticals Inc in its drug Risperdal on Dec 29, 1993. Other drugs containing Risperidone are Perseris Kit, Uzedy, Risvan, Rykindo, Risperdal Consta. 44 different companies have introduced drugs containing Risperidone.

Risperidone Patents

Given below is the list of patents protecting Risperidone, 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
Uzedy	US12128132	Drug delivery formulations	Sep 11, 2040	Teva
Uzedy	US9023897	Biodegradable drug delivery compositions	Apr 05, 2033	Teva
Rykindo	US10098882	Risperidone sustained release microsphere composition	Apr 10, 2032	Shandong Luye
Rykindo	US10406161	Risperidone sustained release microsphere composition	Apr 10, 2032	Shandong Luye
Rykindo	US11110094	Risperidone sustained release microsphere composition	Apr 10, 2032	Shandong Luye
Rykindo	US9446135	Risperidone sustained release microsphere composition	Apr 10, 2032	Shandong Luye
Rykindo	US9532991	Risperidone sustained release microsphere composition	Apr 10, 2032	Shandong Luye
Risvan	US10058504	Methods for the preparation of injectable depot compositions	May 31, 2031	Labs Farms Rovi Sa
Risvan	US10085936	Antipsychotic injectable depot composition	May 31, 2031	Labs Farms Rovi Sa
Risvan	US10182982	Antipsychotic injectable depot composition	May 31, 2031	Labs Farms Rovi Sa
Risvan	US10195138	Methods for the preparation of injectable depot compositions	May 31, 2031	Labs Farms Rovi Sa
Risvan	US10335366	Risperidone or paliperidone implant formulation	May 31, 2031	Labs Farms Rovi Sa
Risvan	US10463607	Antipsychotic Injectable Depot Composition	May 31, 2031	Labs Farms Rovi Sa
Risvan	US10881605	Methods for the preparation of injectable depot compositions	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11007139	Risperidone or paliperidone implant formulation	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11173110	Risperidone or paliperidone implant formulation	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11241377	Antipsychotic injectable depot composition	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11752092	Methods for the preparation of injectable depot compositions	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11752093	Antipsychotic injectable depot composition	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11752094	Antipsychotic injectable depot composition	May 31, 2031	Labs Farms Rovi Sa
Risvan	US11759416	Antipsychotic injectable depot composition	May 31, 2031	Labs Farms Rovi Sa
Perseris Kit	US10010612	Sustained delivery formulations of risperidone compounds	Feb 13, 2028	Indivior
Perseris Kit	US10376590	Sustained delivery formulations of risperidone compound	Feb 13, 2028	Indivior
Perseris Kit	US11013809	Sustained delivery formulations of risperidone compound	Feb 13, 2028	Indivior
Perseris Kit	US11712475	Sustained delivery formulations of risperidone compound	Feb 13, 2028	Indivior
Perseris Kit	US9180197	Sustained delivery formulations of risperidone compounds	Feb 13, 2028	Indivior
Perseris Kit	US9186413	Sustained delivery formulations of risperidone compounds	Feb 13, 2028	Indivior
Uzedy	US8221778	Drug-containing implants and methods of use thereof	Nov 12, 2027	Teva
Uzedy	US8741327	Method of maintaining therapeutic risperidone levels in a PLA:PLGA implant	Nov 12, 2027	Teva
Perseris Kit	US11110093	Sustained release small molecule drug formulation	Nov 05, 2026	Indivior
Perseris Kit	US10058554	Sustained release small molecule drug formulation	Sep 26, 2026	Indivior
Perseris Kit	US9597402	Sustained release small molecule drug formulation	Sep 26, 2026	Indivior
Perseris Kit	US10406160	Sustained release small molecule drug formulation	Jun 26, 2026	Indivior
Uzedy	US10736965	Risperidone biodegradable implant	Jan 12, 2025 (Expired)	Teva
Uzedy	US8802127	Risperidone-containing PLA:PGA implants and methods of use thereof	Jan 12, 2025 (Expired)	Teva
Uzedy	US9439905	Risperidone-containing implants and methods of use thereof	Jan 12, 2025 (Expired)	Teva
Uzedy	US9717799	Drug-containing implants and methods of use thereof	Jan 12, 2025 (Expired)	Teva
Uzedy	US9895447	Drug-containing PLA implants and methods of use thereof	Jan 12, 2025 (Expired)	Teva
Uzedy	US9925268	Drug-containing implants and methods of use thereof	Jan 12, 2025 (Expired)	Teva
Risperdal Consta	US6667061 (Pediatric)	Preparation of injectable suspensions having improved injectability	Nov 25, 2020 (Expired)	Janssen Pharms
Risperdal Consta	US6667061	Preparation of injectable suspensions having improved injectability	May 25, 2020 (Expired)	Janssen Pharms
Risperdal Consta	US6194006 (Pediatric)	Preparation of microparticles having a selected release profile	Jun 30, 2019 (Expired)	Janssen Pharms
Risperdal Consta	US6379703 (Pediatric)	Preparation of microparticles having a selected release profile	Jun 30, 2019 (Expired)	Janssen Pharms
Risperdal Consta	US6596316 (Pediatric)	Preparation of microparticles having a selected release profile	Jun 30, 2019 (Expired)	Janssen Pharms
Risperdal Consta	US6194006	Preparation of microparticles having a selected release profile	Dec 30, 2018 (Expired)	Janssen Pharms
Risperdal Consta	US6379703	Preparation of microparticles having a selected release profile	Dec 30, 2018 (Expired)	Janssen Pharms
Risperdal Consta	US6596316	Preparation of microparticles having a selected release profile	Dec 30, 2018 (Expired)	Janssen Pharms
Risperdal	US6224905 (Pediatric)	Biconvex rapidly disintegrating dosage forms	Dec 10, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US5792477 (Pediatric)	Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent	Nov 02, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US5916598 (Pediatric)	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	Nov 02, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US6403114 (Pediatric)	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	Nov 02, 2017 (Expired)	Janssen Pharms
Risperdal	US6224905	Biconvex rapidly disintegrating dosage forms	Jun 10, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US5792477	Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent	May 02, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US5916598	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	May 02, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US6403114	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	May 02, 2017 (Expired)	Janssen Pharms
Risperdal Consta	US5688801 (Pediatric)	Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May 18, 2015 (Expired)	Janssen Pharms
Risperdal	US5648093 (Pediatric)	Pharmaceutical and other dosage forms	Jan 15, 2015 (Expired)	Janssen Pharms
Risperdal	US5453425 (Pediatric)	Risperidone oral formulation	Jan 11, 2015 (Expired)	Janssen Pharms
Risperdal	USRE39181 (Pediatric)	Aqueous risperidone formulations	Jan 11, 2015 (Expired)	Janssen Pharms
Risperdal Consta	US5688801	Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov 18, 2014 (Expired)	Janssen Pharms
Risperdal	US5648093	Pharmaceutical and other dosage forms	Jul 15, 2014 (Expired)	Janssen Pharms
Risperdal	US5453425	Risperidone oral formulation	Jul 11, 2014 (Expired)	Janssen Pharms
Risperdal	USRE39181	Aqueous risperidone formulations	Jul 11, 2014 (Expired)	Janssen Pharms
Risperdal Consta	US5965168 (Pediatric)	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May 19, 2014 (Expired)	Janssen Pharms
Risperdal Consta	US6110921 (Pediatric)	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May 19, 2014 (Expired)	Janssen Pharms
Risperdal Consta	US6368632 (Pediatric)	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May 19, 2014 (Expired)	Janssen Pharms
Risperdal Consta	US7547452 (Pediatric)	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May 19, 2014 (Expired)	Janssen Pharms
Risperdal Consta	US5965168	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov 19, 2013 (Expired)	Janssen Pharms
Risperdal Consta	US6110921	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov 19, 2013 (Expired)	Janssen Pharms
Risperdal Consta	US6368632	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov 19, 2013 (Expired)	Janssen Pharms
Risperdal Consta	US7547452	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov 19, 2013 (Expired)	Janssen 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 Risperidone's patents.

Latest Legal Activities on Risperidone's Patents

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

Activity	Date	Patent Number

Payment of Maintenance Fee, 8th Year, Large Entity	03 Jul, 2024	US9532991
Surcharge for Late Payment, Large Entity	17 Apr, 2024	US10736965
Payment of Maintenance Fee, 4th Year, Large Entity	17 Apr, 2024	US10736965
Maintenance Fee Reminder Mailed Critical	01 Apr, 2024	US10736965
Payment of Maintenance Fee, 8th Year, Large Entity	19 Mar, 2024	US9446135
Payment of Maintenance Fee, 8th Year, Large Entity	28 Feb, 2024	US9439905
Payment of Maintenance Fee, 12th Yr, Small Entity	03 Jan, 2024	US8221778
Payment of Maintenance Fee, 4th Year, Large Entity	10 Mar, 2023	US10406161
Payment of Maintenance Fee, 8th Year, Large Entity	02 Nov, 2022	US9023897
Payment of Maintenance Fee, 4th Year, Large Entity	28 Mar, 2022	US10098882

Risperidone's Family Patents

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Risperidone Generic API Manufacturers

Several generic applications have been filed for Risperidone. The first generic version for Risperidone was by Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc and was approved on Jun 30, 2008. And the latest generic version is by Ipca Laboratories Ltd and was approved on Jun 26, 2024.

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

1. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 5 different strengths of generic version for Risperidone. 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
4MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Apr 19, 2011
0.5MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Apr 19, 2011
1MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Apr 19, 2011
3MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Apr 19, 2011
2MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Apr 19, 2011

2. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 6 different strengths of generic version for Risperidone. 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
2MG	tablet	Prescription	ORAL	AB	Aug 24, 2011
3MG	tablet	Prescription	ORAL	AB	Aug 24, 2011
0.5MG	tablet	Prescription	ORAL	AB	Aug 24, 2011
1MG	tablet	Prescription	ORAL	AB	Aug 24, 2011
4MG	tablet	Prescription	ORAL	AB	Aug 24, 2011
0.25MG	tablet	Prescription	ORAL	AB	Aug 24, 2011

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.

3. AMNEAL

Amneal Pharmaceuticals Llc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Amneal.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet	Prescription	ORAL	AB	Jun 17, 2009
4MG	tablet	Prescription	ORAL	AB	Jun 17, 2009
3MG	tablet	Prescription	ORAL	AB	Jun 17, 2009
2MG	tablet	Prescription	ORAL	AB	Jun 17, 2009
0.25MG	tablet	Prescription	ORAL	AB	Jun 17, 2009
0.5MG	tablet	Prescription	ORAL	AB	Jun 17, 2009

Manufacturing Plant Locations
^New

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

Country

City

Firm Name

United States

Hauppauge	Amneal Pharmaceuticals of New York, LLC
Bridgewater	Amneal Complex Products Research LLC
Paterson	Amneal Pharmaceuticals, Llc
East Hanover	Amneal Pharmaceuticals LLC
Piscataway	Amneal Pharmaceuticals, LLC
Glasgow	Amneal Pharmaceuticals LLC
Branchburg	Amneal Pharmaceuticals, LLC
Brookhaven	Amneal Pharmaceuticals of New York, LLC

India

Hyderabad	Amneal Oncology Private Limited
Tal Bavla, Ahmedabad	Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad	Amneal Pharmaceuticals Private Ltd.
Matoda	Amneal Pharmaceuticals Private Ltd.

4. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Risperidone. 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
1MG/ML	solution	Prescription	ORAL	AA	May 25, 2011

5. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 1 generic for Risperidone. 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
1MG/ML	solution	Discontinued	ORAL	N/A	Jan 30, 2009

6. APOTEX INC

Apotex Inc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
4MG	tablet	Discontinued	ORAL	N/A	Sep 15, 2008
3MG	tablet	Discontinued	ORAL	N/A	Sep 15, 2008
2MG	tablet	Discontinued	ORAL	N/A	Sep 15, 2008
1MG	tablet	Discontinued	ORAL	N/A	Sep 15, 2008
0.5MG	tablet	Discontinued	ORAL	N/A	Sep 15, 2008
0.25MG	tablet	Discontinued	ORAL	N/A	Sep 15, 2008

Manufacturing Plant Locations
^New

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

Country

City

Firm Name

Canada

Toronto	Apotex Inc.
North York	Apotex Inc.
Richmond Hill	Apotex Inc.

7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Risperidone. 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
1MG/ML	solution	Prescription	ORAL	AA	Sep 4, 2009

Manufacturing Plant Locations
^New

Aurobindo 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 Aurobindo Pharma Ltd as present at those locations.

Country

City

Firm Name

India

Medchal

Aurobindo Pharma Ltd

8. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 7 different strengths of generic version for Risperidone. 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
1MG	tablet	Prescription	ORAL	AB	May 18, 2011
4MG	tablet	Prescription	ORAL	AB	May 18, 2011
3MG	tablet	Prescription	ORAL	AB	May 18, 2011
2MG	tablet	Prescription	ORAL	AB	May 18, 2011
0.5MG	tablet	Prescription	ORAL	AB	May 18, 2011
0.25MG	tablet	Prescription	ORAL	AB	May 18, 2011
1MG/ML	solution	Prescription	ORAL	AA	Jan 12, 2015

9. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Risperidone. 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
0.5MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 12, 2012
1MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 12, 2012
2MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 12, 2012

10. DASH PHARMS

Dash Pharmaceuticals Llc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Dash Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.25MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Feb 12, 2013
0.5MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 30, 2011
1MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 30, 2011
2MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 30, 2011
3MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 30, 2011
4MG	tablet, orally disintegrating	Discontinued	ORAL	N/A	Mar 30, 2011

11. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet, orally disintegrating	Prescription	ORAL	AB	Oct 5, 2009
4MG	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 30, 2009
2MG	tablet, orally disintegrating	Prescription	ORAL	AB	Feb 24, 2009
0.25MG	tablet	Prescription	ORAL	AB	Oct 24, 2008
0.5MG	tablet, orally disintegrating	Prescription	ORAL	AB	Feb 24, 2009
3MG	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 30, 2009

12. ENDO OPERATIONS

Endo Operations Ltd has filed for 6 different strengths of generic version for Risperidone. 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
0.25MG	tablet, orally disintegrating	Prescription	ORAL	N/A	Apr 30, 2009
0.5MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 30, 2009
2MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 30, 2009
3MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 30, 2009
4MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 30, 2009
1MG	tablet, orally disintegrating	Prescription	ORAL	AB	Oct 26, 2009

13. ESJAY PHARMA

Esjay Pharma Llc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Esjay Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.5MG	tablet	Prescription	ORAL	AB	Oct 9, 2008
3MG	tablet	Prescription	ORAL	AB	Oct 9, 2008
0.25MG	tablet	Prescription	ORAL	AB	Oct 9, 2008
2MG	tablet	Prescription	ORAL	AB	Oct 9, 2008
1MG	tablet	Prescription	ORAL	AB	Oct 9, 2008
4MG	tablet	Prescription	ORAL	AB	Oct 9, 2008

14. HERITAGE PHARMA AVET

Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Heritage Pharma Avet.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.25MG	tablet	Discontinued	ORAL	N/A	Oct 16, 2008
0.5MG	tablet	Discontinued	ORAL	N/A	Oct 16, 2008
1MG	tablet	Discontinued	ORAL	N/A	Oct 16, 2008
2MG	tablet	Discontinued	ORAL	N/A	Oct 16, 2008
3MG	tablet	Discontinued	ORAL	N/A	Oct 16, 2008
4MG	tablet	Discontinued	ORAL	N/A	Oct 16, 2008

15. HIKMA

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

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Discontinued	ORAL	N/A	Jul 29, 2009

Manufacturing Plant Locations
^New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country

City

Firm Name

United States

Eatontown	Hikma Pharmaceuticals USA, Inc.
Carlsbad	Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton	Hikma Injectables USA Inc
Cherry Hill	Hikma Pharmaceuticals USA Inc.

Portugal

Terrugem Snt

Hikma Farmaceutica, (Portugal) S.A.

Jordan

Amman

Hikma Pharmaceuticals LLC

16. IPCA LABS LTD

Ipca Laboratories Ltd has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Ipca Labs Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
4MG	tablet	Prescription	ORAL	AB	Jun 26, 2024
3MG	tablet	Prescription	ORAL	AB	Jun 26, 2024
2MG	tablet	Prescription	ORAL	AB	Jun 26, 2024
1MG	tablet	Prescription	ORAL	AB	Jun 26, 2024
0.5MG	tablet	Prescription	ORAL	AB	Jun 26, 2024
0.25MG	tablet	Prescription	ORAL	AB	Jun 26, 2024

17. JUBILANT CADISTA

Jubilant Cadista Pharmaceuticals Inc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Jubilant Cadista.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
4MG	tablet	Discontinued	ORAL	N/A	Mar 23, 2009
0.25MG	tablet	Discontinued	ORAL	N/A	Mar 23, 2009
0.5MG	tablet	Discontinued	ORAL	N/A	Mar 23, 2009
1MG	tablet	Discontinued	ORAL	N/A	Mar 23, 2009
2MG	tablet	Discontinued	ORAL	N/A	Mar 23, 2009
3MG	tablet	Discontinued	ORAL	N/A	Mar 23, 2009

Manufacturing Plant Locations
^New

Jubilant Cadista'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 Jubilant Cadista as present at those locations.

Country

City

Firm Name

United States

Salisbury

Jubilant Cadista Pharmaceuticals, Inc.

18. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 5 different strengths of generic version for Risperidone. 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
0.5MG	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 4, 2011
2MG	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 4, 2011
4MG	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 4, 2011
1MG (reference standard)	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 4, 2011
3MG	tablet, orally disintegrating	Prescription	ORAL	AB	Nov 4, 2011

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

19. LANNETT CO INC

Lannett Co Inc has filed for 1 generic for Risperidone. 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
1MG/ML	solution	Discontinued	ORAL	N/A	Dec 3, 2010

20. PHARM ASSOC

Pharmaceutical Associates Inc has filed for 1 generic for Risperidone. Given below are the details of the strengths of this generic introduced by Pharm Assoc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Discontinued	ORAL	N/A	Jul 29, 2009

21. PRECISION DOSE

Precision Dose Inc has filed for 1 generic for Risperidone. Given below are the details of the strengths of this generic introduced by Precision Dose.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Discontinued	ORAL	N/A	Jun 28, 2010

Manufacturing Plant Locations
^New

Precision Dose'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 Precision Dose as present at those locations.

Country

City

Firm Name

United States

South Beloit

Precision Dose Inc.

22. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 6 different strengths of generic version for Risperidone. 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
0.5MG	tablet	Prescription	ORAL	AB	Nov 29, 2011
4MG	tablet	Prescription	ORAL	AB	Nov 29, 2011
3MG	tablet	Prescription	ORAL	AB	Nov 29, 2011
2MG	tablet	Prescription	ORAL	AB	Nov 29, 2011
1MG	tablet	Prescription	ORAL	AB	Nov 29, 2011
0.25MG	tablet	Prescription	ORAL	AB	Nov 29, 2011

23. RATIOPHARM

Ratiopharm has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Ratiopharm.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Discontinued	ORAL	N/A	Jun 8, 2010
3MG	tablet	Discontinued	ORAL	N/A	Jun 8, 2010
1MG	tablet	Discontinued	ORAL	N/A	Jun 8, 2010
0.5MG	tablet	Discontinued	ORAL	N/A	Jun 8, 2010
0.25MG	tablet	Discontinued	ORAL	N/A	Jun 8, 2010
4MG	tablet	Discontinued	ORAL	N/A	Jun 8, 2010

Manufacturing Plant Locations
^New

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

Country

City

Firm Name

Germany

Ulm	Ratiopharm GmbH

24. RENATA

Renata Ltd has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Renata.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
4MG	tablet	Prescription	ORAL	AB	Dec 29, 2008
2MG	tablet	Prescription	ORAL	AB	Dec 29, 2008
3MG	tablet	Prescription	ORAL	AB	Dec 29, 2008
0.5MG	tablet	Prescription	ORAL	AB	Dec 29, 2008
0.25MG	tablet	Prescription	ORAL	AB	Dec 29, 2008
1MG	tablet	Prescription	ORAL	AB	Dec 29, 2008

Manufacturing Plant Locations
^New

Renata's manufacturing plants are situated in 5 countries - Brazil, United States, Hungary, Bangladesh, Poland. Given below are the details of these plant locations as well as the firm names of Renata as present at those locations.

Country

City

Firm Name

Brazil

Rio De Janeiro

Renata de Souza Cravo

United States

San Francisco

Renata Gallagher, M.D.

Hungary

Miskolc

Renata Kun, M.D.

Bangladesh

Gazipur

Renata Limited (General Plant 2)

Poland

Warsaw

Renata Sienkiewicz-Kozlowska, MD

25. RISING

Rising Pharma Holdings Inc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Rising.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.5MG	tablet	Prescription	ORAL	AB	Oct 8, 2008
4MG	tablet	Prescription	ORAL	AB	Oct 8, 2008
3MG	tablet	Prescription	ORAL	AB	Oct 8, 2008
2MG	tablet	Prescription	ORAL	AB	Oct 8, 2008
1MG	tablet	Prescription	ORAL	AB	Oct 8, 2008
0.25MG	tablet	Prescription	ORAL	AB	Oct 8, 2008

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

Livingston	Risingsun Iodine Products Corp.
Mount Morris	Rising Creek Bakery LLC
East Brunswick	Rising Pharma Holding, Inc.
Rising Sun	Rising Sun Veterinary Clinic
Fort Bragg	Rising Tide Sea Vegetables
Phoenix	Rising Sun Farms Inc
Saddle Brook	Rising Pharmaceuticals, Inc.
Flagstaff	Rising High Enterprises, LLC (DBA RisingHy)
Decatur	Rising Pharma Holdings, Inc

Mexico

Pueblo San Clemente

RISING FARMS SAPI DE CV

India

Ahmedabad

Rising Retina Clinic

26. SANDOZ

Sandoz Inc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 22, 2009
1MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 22, 2009
0.5MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 22, 2009
0.25MG	tablet	Prescription	ORAL	AB	Oct 16, 2009
4MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 22, 2009
3MG	tablet, orally disintegrating	Prescription	ORAL	AB	Dec 22, 2009

Manufacturing Plant Locations
^New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country

City

Firm Name

Austria

Kundl	Sandoz GmbH
Langkampfen	Sandoz GmbH

United States

East Hanover	Sandoz Incorporated
Princeton	Sandoz Inc

Spain

Les Franqueses Del Valles	Sandoz Industrial Products S.A.
Palafolls	Sandoz Industrial Products, S.A.

India

Navi Mumbai

Sandoz Private Limited

27. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Risperidone. 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
1MG/ML	solution	Discontinued	ORAL	N/A	Jul 29, 2009

28. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 6 different strengths of generic version for Risperidone. 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
0.25MG	tablet	Discontinued	ORAL	N/A	Mar 10, 2014
1MG	tablet	Discontinued	ORAL	N/A	Mar 10, 2014
4MG	tablet	Discontinued	ORAL	N/A	Mar 10, 2014
3MG	tablet	Discontinued	ORAL	N/A	Mar 10, 2014
2MG	tablet	Discontinued	ORAL	N/A	Mar 10, 2014
0.5MG	tablet	Discontinued	ORAL	N/A	Mar 10, 2014

29. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 5 different strengths of generic version for Risperidone. 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
3MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 8, 2013
4MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 8, 2013
1MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 8, 2013
0.5MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 8, 2013
2MG	tablet, orally disintegrating	Prescription	ORAL	AB	Apr 8, 2013

30. SYNTHON PHARMS

Synthon Pharmaceuticals Inc has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by Synthon Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Discontinued	ORAL	N/A	Oct 22, 2009
3MG	tablet	Discontinued	ORAL	N/A	Oct 22, 2009
4MG	tablet	Discontinued	ORAL	N/A	Oct 22, 2009
0.25MG	tablet	Discontinued	ORAL	N/A	Oct 22, 2009
0.5MG	tablet	Discontinued	ORAL	N/A	Oct 22, 2009
1MG	tablet	Discontinued	ORAL	N/A	Oct 22, 2009

31. TARO

Taro Pharmaceuticals Inc has filed for 1 generic for Risperidone. Given below are the details of the strengths of this generic introduced by Taro.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Prescription	ORAL	AA	Feb 7, 2011

Manufacturing Plant Locations
^New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country

City

Firm Name

United States

Hawthorne	Taro Pharmaceuticals U.S.A., Inc.
Honolulu	Taro Delight, LLC

Israel

Haifa

Taro Pharmaceutical Industries, Ltd.

Canada

Brampton

Taro Pharmaceuticals Inc.

32. TEVA PHARMS USA INC

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

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
12.5MG/VIAL	injectable	Prescription	INTRAMUSCULAR	AB	Dec 5, 2023
25MG/VIAL	injectable	Prescription	INTRAMUSCULAR	AB	Dec 5, 2023
37.5MG/VIAL	injectable	Prescription	INTRAMUSCULAR	AB	Dec 5, 2023
50MG/VIAL	injectable	Prescription	INTRAMUSCULAR	AB	Dec 5, 2023

33. TORRENT PHARMS

Torrent Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Risperidone. 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
0.5MG	tablet	Prescription	ORAL	AB	Oct 30, 2008
4MG	tablet	Prescription	ORAL	AB	Oct 30, 2008
3MG	tablet	Prescription	ORAL	AB	Oct 30, 2008
2MG	tablet	Prescription	ORAL	AB	Oct 30, 2008
1MG	tablet	Prescription	ORAL	AB	Oct 30, 2008
0.25MG	tablet	Prescription	ORAL	AB	Oct 30, 2008

34. TRIS PHARMA INC

Tris Pharma Inc has filed for 1 generic for Risperidone. 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
1MG/ML	solution	Prescription	ORAL	AA	Dec 12, 2012

Manufacturing Plant Locations
^New

Tris Pharma Inc'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 Tris Pharma Inc as present at those locations.

Country

City

Firm Name

United States

Monmouth Junction

Tris Pharma Inc.

35. WATSON LABS

Watson Laboratories Inc has filed for 6 different strengths of generic version for Risperidone. 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
0.5MG	tablet	Discontinued	ORAL	N/A	Dec 5, 2008
1MG	tablet	Discontinued	ORAL	N/A	Dec 5, 2008
2MG	tablet	Discontinued	ORAL	N/A	Dec 5, 2008
3MG	tablet	Discontinued	ORAL	N/A	Dec 5, 2008
4MG	tablet	Discontinued	ORAL	N/A	Dec 5, 2008
0.25MG	tablet	Discontinued	ORAL	N/A	Dec 5, 2008

36. WEST WARD PHARMS

West Ward Pharmaceuticals Corp has filed for 6 different strengths of generic version for Risperidone. Given below are the details of the strengths of this generic introduced by West Ward Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.5MG	tablet	Discontinued	ORAL	N/A	May 29, 2009
1MG	tablet	Discontinued	ORAL	N/A	May 29, 2009
2MG	tablet	Discontinued	ORAL	N/A	May 29, 2009
3MG	tablet	Discontinued	ORAL	N/A	May 29, 2009
4MG	tablet	Discontinued	ORAL	N/A	May 29, 2009
0.25MG	tablet	Discontinued	ORAL	N/A	May 29, 2009

37. WOCKHARDT

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

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG/ML	solution	Discontinued	ORAL	N/A	Oct 8, 2009

Manufacturing Plant Locations
^New

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

Country

City

Firm Name

India

Ankleshwar	Wockhardt, Ltd.
Solan, Nalagarh	Wockhardt Limited - Baddi
Aurangabad	Wockhardt Limited

38. ZYDUS PHARMS USA

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

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet, orally disintegrating	Prescription	ORAL	AB	May 1, 2009
0.5MG	tablet, orally disintegrating	Prescription	ORAL	AB	May 1, 2009

39. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Risperidone. 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
3MG	tablet	Prescription	ORAL	AB	Oct 16, 2008
4MG	tablet	Prescription	ORAL	AB	Oct 16, 2008
0.25MG	tablet	Prescription	ORAL	AB	Oct 16, 2008
0.5MG	tablet	Prescription	ORAL	AB	Oct 16, 2008
1MG	tablet	Prescription	ORAL	AB	Oct 16, 2008
2MG	tablet	Prescription	ORAL	AB	Oct 16, 2008

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2. AJANTA PHARMA LTD

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3. AMNEAL

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4. AMNEAL PHARMS

5. ANI PHARMS

6. APOTEX INC

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7. AUROBINDO PHARMA LTD

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8. CHARTWELL MOLECULAR

9. CHARTWELL RX

10. DASH PHARMS

11. DR REDDYS LABS LTD

12. ENDO OPERATIONS

13. ESJAY PHARMA

14. HERITAGE PHARMA AVET

15. HIKMA

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16. IPCA LABS LTD

17. JUBILANT CADISTA

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18. JUBILANT GENERICS

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19. LANNETT CO INC

20. PHARM ASSOC

21. PRECISION DOSE

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22. PRINSTON INC

23. RATIOPHARM

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24. RENATA

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25. RISING

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26. SANDOZ

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27. SCIEGEN PHARMS INC

28. SUN PHARM INDS INC

29. SUN PHARM INDS LTD

30. SYNTHON PHARMS

31. TARO

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32. TEVA PHARMS USA INC

33. TORRENT PHARMS

34. TRIS PHARMA INC

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35. WATSON LABS

36. WEST WARD PHARMS

37. WOCKHARDT

Manufacturing Plant Locations New

38. ZYDUS PHARMS USA

39. ZYDUS PHARMS USA INC

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