Pharsight

1. Perseris Kit patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP08725543A	2016-10-06	Lecomte & Partners	Opposition rejected
EP11162857A	2014-04-17	Generics [UK] Limited	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10406160	INDIVIOR	Sustained release small molecule drug formulation	Jun, 2026 (2 years from now)
US9597402	INDIVIOR	Sustained release small molecule drug formulation	Sep, 2026 (2 years from now)
US10058554	INDIVIOR	Sustained release small molecule drug formulation	Sep, 2026 (2 years from now)
US11110093	INDIVIOR	Sustained release small molecule drug formulation	Nov, 2026 (2 years from now)
US9180197	INDIVIOR	Sustained delivery formulations of risperidone compounds	Feb, 2028 (3 years from now)
US11013809	INDIVIOR	Sustained delivery formulations of risperidone compound	Feb, 2028 (3 years from now)
US11712475	INDIVIOR	Sustained delivery formulations of risperidone compound	Feb, 2028 (3 years from now)
US10010612	INDIVIOR	Sustained delivery formulations of risperidone compounds	Feb, 2028 (3 years from now)
US10376590	INDIVIOR	Sustained delivery formulations of risperidone compound	Feb, 2028 (3 years from now)
US9186413	INDIVIOR	Sustained delivery formulations of risperidone compounds	Feb, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jul 27, 2021

Market Authorisation Date: 27 July, 2018

Treatment: Method of treating schizophrenia; Administration of risperidone; Treating schizophrenia; Treatment of schizophrenia

Dosage: FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

Strength	Dosage	Availability
90MG	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription
120MG	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription

PERSERIS KIT family patents

2. Risperdal patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5453425	JANSSEN PHARMS	Risperidone oral formulation	Jul, 2014 (9 years ago)
USRE39181	JANSSEN PHARMS	Aqueous risperidone formulations	Jul, 2014 (9 years ago)
US5648093	JANSSEN PHARMS	Pharmaceutical and other dosage forms	Jul, 2014 (9 years ago)
USRE39181 (Pediatric)	JANSSEN PHARMS	Aqueous risperidone formulations	Jan, 2015 (9 years ago)
US5453425 (Pediatric)	JANSSEN PHARMS	Risperidone oral formulation	Jan, 2015 (9 years ago)
US5648093 (Pediatric)	JANSSEN PHARMS	Pharmaceutical and other dosage forms	Jan, 2015 (9 years ago)
US6224905	JANSSEN PHARMS	Biconvex rapidly disintegrating dosage forms	Jun, 2017 (6 years ago)
US6224905 (Pediatric)	JANSSEN PHARMS	Biconvex rapidly disintegrating dosage forms	Dec, 2017 (6 years ago)

Market Authorisation Date: 10 June, 1996

Treatment: NA

Dosage: SOLUTION;ORAL; TABLET, ORALLY DISINTEGRATING;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1 mg/mL
0.25 mg, 1 mg, 2 mg, 3 mg and 4 mg
0.25 mg	11 Apr, 2005	1	30 Apr, 2009	10 Jun, 2017	Eligible
0.5 mg, 1 mg and 2 mg
3 mg and 4 mg	23 Mar, 2005	1	30 Apr, 2009	10 Jun, 2017	Eligible

Strength	Dosage	Availability
1MG/ML	SOLUTION;ORAL	Prescription
0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued

RISPERDAL family patents

3. Risperdal Consta patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6110921	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov, 2013 (10 years ago)
US6368632	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov, 2013 (10 years ago)
US7547452	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov, 2013 (10 years ago)
US5965168	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov, 2013 (10 years ago)
US6110921 (Pediatric)	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May, 2014 (9 years ago)
US7547452 (Pediatric)	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May, 2014 (9 years ago)
US5965168 (Pediatric)	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May, 2014 (9 years ago)
US6368632 (Pediatric)	JANSSEN PHARMS	Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May, 2014 (9 years ago)
US5688801	JANSSEN PHARMS	Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	Nov, 2014 (9 years ago)
US5688801 (Pediatric)	JANSSEN PHARMS	Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles	May, 2015 (8 years ago)
US5916598	JANSSEN PHARMS	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	May, 2017 (6 years ago)
US5792477	JANSSEN PHARMS	Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent	May, 2017 (6 years ago)
US6403114	JANSSEN PHARMS	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	May, 2017 (6 years ago)
US6403114 (Pediatric)	JANSSEN PHARMS	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	Nov, 2017 (6 years ago)
US5916598 (Pediatric)	JANSSEN PHARMS	Preparation of biodegradable, biocompatible microparticles containing a biologically active agent	Nov, 2017 (6 years ago)
US5792477 (Pediatric)	JANSSEN PHARMS	Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent	Nov, 2017 (6 years ago)
US6596316	JANSSEN PHARMS	Preparation of microparticles having a selected release profile	Dec, 2018 (5 years ago)
US6194006	JANSSEN PHARMS	Preparation of microparticles having a selected release profile	Dec, 2018 (5 years ago)
US6379703	JANSSEN PHARMS	Preparation of microparticles having a selected release profile	Dec, 2018 (5 years ago)
US6194006 (Pediatric)	JANSSEN PHARMS	Preparation of microparticles having a selected release profile	Jun, 2019 (4 years ago)
US6379703 (Pediatric)	JANSSEN PHARMS	Preparation of microparticles having a selected release profile	Jun, 2019 (4 years ago)
US6596316 (Pediatric)	JANSSEN PHARMS	Preparation of microparticles having a selected release profile	Jun, 2019 (4 years ago)
US6667061	JANSSEN PHARMS	Preparation of injectable suspensions having improved injectability	May, 2020 (3 years ago)
US6667061 (Pediatric)	JANSSEN PHARMS	Preparation of injectable suspensions having improved injectability	Nov, 2020 (3 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-597)	May 15, 2012
New Indication(I-596)	May 15, 2012

Market Authorisation Date: 12 April, 2007

Treatment: Treatment of schizophrenia; Monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar i disorder

Dosage: INJECTABLE;INTRAMUSCULAR

Strength	Dosage	Availability
12.5MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription
25MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription
37.5MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription
50MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription

RISPERDAL CONSTA family patents

4. Rykindo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP19176691A	2021-07-07	Alkermes Pharma Ireland Limited	Opposition rejected
EP16179390A	2020-04-17	Alkermes Pharma Ireland Limited	Opposition rejected
EP16179390A	2020-04-14	Aera A/S	Opposition rejected
EP12777430A	2017-06-20	Lecomte & Partners	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9446135	SHANDONG LUYE	Risperidone sustained release microsphere composition	Apr, 2032 (7 years from now)
US9532991	SHANDONG LUYE	Risperidone sustained release microsphere composition	Apr, 2032 (7 years from now)
US11110094	SHANDONG LUYE	Risperidone sustained release microsphere composition	Apr, 2032 (7 years from now)
US10406161	SHANDONG LUYE	Risperidone sustained release microsphere composition	Apr, 2032 (7 years from now)
US10098882	SHANDONG LUYE	Risperidone sustained release microsphere composition	Apr, 2032 (7 years from now)

Market Authorisation Date: 13 January, 2023

Treatment: Treatment of schizophrenia in adults

Dosage: FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Strength	Dosage	Availability
50MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
12.5MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
37.5MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
25MG	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription

RYKINDO family patents

5. Uzedy patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9717799	TEVA	Drug-containing implants and methods of use thereof	Jan, 2025 (8 months from now)
US8802127	TEVA	Risperidone-containing PLA:PGA implants and methods of use thereof	Jan, 2025 (8 months from now)
US10736965	TEVA	Risperidone biodegradable implant	Jan, 2025 (8 months from now)
US9439905	TEVA	Risperidone-containing implants and methods of use thereof	Jan, 2025 (8 months from now)
US9925268	TEVA	Drug-containing implants and methods of use thereof	Jan, 2025 (8 months from now)
US9895447	TEVA	Drug-containing PLA implants and methods of use thereof	Jan, 2025 (8 months from now)
US8741327	TEVA	Method of maintaining therapeutic risperidone levels in a PLA:PLGA implant	Nov, 2027 (3 years from now)
US8221778	TEVA	Drug-containing implants and methods of use thereof	Nov, 2027 (3 years from now)
US9023897	TEVA	Biodegradable drug delivery compositions	Apr, 2033 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Apr 28, 2026

Market Authorisation Date: 28 April, 2023

Treatment: Treatment of schizophrenia

Dosage: SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS