Pharsight

1. Opvee patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11458091	INDIVIOR	Compositions and methods for the treatment of opioid overdose	Jul, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 22, 2026

Drugs and Companies using NALMEFENE HYDROCHLORIDE ingredient

Market Authorisation Date: 22 May, 2023

Treatment: Treating opioid overdose

Dosage: SPRAY;NASAL

Strength	Dosage	Availability
EQ 2.7MG BASE/SPRAY	SPRAY;NASAL	Prescription

OPVEE family patents

2. 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)
US10058554	INDIVIOR	Sustained release small molecule drug formulation	Sep, 2026 (2 years from now)
US9597402	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)
US10010612	INDIVIOR	Sustained delivery formulations of risperidone compounds	Feb, 2028 (3 years from now)
US11712475	INDIVIOR	Sustained delivery formulations of risperidone compound	Feb, 2028 (3 years from now)
US10376590	INDIVIOR	Sustained delivery formulations of risperidone compound	Feb, 2028 (3 years from now)
US9180197	INDIVIOR	Sustained delivery formulations of risperidone compounds	Feb, 2028 (3 years from now)
US9186413	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)

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

Drugs and Companies using RISPERIDONE ingredient

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

3. Sublocade patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP15828368A	2021-03-30	ELKINGTON AND FIFE LLP	Granted and Under Opposition
EP11728037A	2018-10-10	Teva Pharmaceutical Industries Ltd.	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).
US9827241	INDIVIOR	Injectable flowable composition comprising buprenorphine	Jun, 2031 (7 years from now)
US9272044	INDIVIOR	Injectable flowable composition buprenorphine	Jun, 2031 (7 years from now)
US10592168	INDIVIOR	Injectable flowable composition comprising buprenorphine	Jun, 2031 (7 years from now)
US9782402	INDIVIOR	Injectable composition comprising buprenorphine	Jun, 2031 (7 years from now)
US10198218	INDIVIOR	Injectable flowable composition comprising buprenorphine	Jun, 2031 (7 years from now)
US9498432	INDIVIOR	Injectable flowable composition comprising buprenorphine	Jun, 2031 (7 years from now)
US10558394	INDIVIOR	Injectable flowable composition comprising buprenorphine	Jun, 2031 (7 years from now)
US8975270	INDIVIOR	Injectable flowable composition comprising buprenorphine	Sep, 2031 (7 years from now)
US8921387	INDIVIOR	Injectable flowable composition comprising buprenorphine	Jan, 2032 (7 years from now)
US11839611	INDIVIOR	Buprenorphine dosing regimens	Nov, 2035 (11 years from now)
US11000520	INDIVIOR	Buprenorphine dosing regimens	Nov, 2035 (11 years from now)
US10646484	INDIVIOR	Methods to treat opioid use disorder	Jun, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 30, 2020

Drugs and Companies using BUPRENORPHINE ingredient

Market Authorisation Date: 30 November, 2017

Treatment: Treating opioid addiction by 100 mg or 300 mg dose buprenorphine; Treating opioid addiction by subcutaneous injection of buprenorphine; Treatment of moderate to severe opioid use disorder; Treating ad...

Dosage: SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS

Strength	Dosage	Availability
100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription
300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription

SUBLOCADE family patents

4. Suboxone patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10740493A	2016-10-25	LTS LOHMANN Therapie-Systeme AG	Patent maintained as amended
EP11157819A	2014-06-11	Ahrens, Gabriele	Patent maintained as amended
EP02782151A	2013-06-12	Acino Pharma AG	Revoked
EP02782151A	2013-06-11	Germann, Sandra	Revoked
EP02801042A	2012-09-14	Ahrens, Gabriele	Patent maintained as amended
EP02801042A	2012-09-11	LTS LOHMANN Therapie-Systeme AG	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9687454	November, 2018	FWD Entered	Indivior UK Limited	Dr. Reddy’s Laboratories S.A.
US9687454	November, 2018	Terminated-Denied	Indivior UK Limited	Dr. Reddy's Laboratories S.A.
US8603514	June, 2017	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy’s Laboratories, Inc.
US8603514	June, 2017	Terminated-Denied	MonoSol Rx, LLC	Par Pharmaceutical, Inc.
US8603514	November, 2016	Terminated-Adverse Judgment	MonoSol Rx, LLC	Mylan Technologies, Inc.
US8475832	May, 2016	Terminated-Denied	Indivior UK Limited	Dr. Reddy’s Laboratories, Inc.
US8603514	May, 2016	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy's Laboratories, Inc.
US8017150	May, 2016	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy’s Laboratories, Inc.
US8017150	December, 2015	Terminated-Denied	MONOSOL RX, LLC	Teva Parmaceuticals USA Inc.
US8603514	December, 2015	Terminated-Denied	MONOSOL RX LLC	Teva Pharmaceuticals USA Inc
US8475832	December, 2015	Terminated-Denied	Indivior UK Limited	Teva Pharmaceuticals USA, Inc.
US8475832	June, 2014	Terminated-Denied	RB Pharmaceuticals Limited	BioDelivery Sciences International, Inc.
US8475832	January, 2014	FWD Entered	RB Pharmaceuticals Limited	BioDelivery Sciences International, Inc.

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).
US9855221	INDIVIOR	Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions	Feb, 2022 (2 years ago)
US9931305	INDIVIOR	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Feb, 2022 (2 years ago)
US10285910	INDIVIOR	Sublingual and buccal film compositions	Oct, 2022 (1 year, 6 months ago)
US8017150	INDIVIOR	Polyethylene oxide-based films and drug delivery systems made therefrom	Feb, 2023 (1 year, 2 months ago)
US8603514	INDIVIOR	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Apr, 2024 (26 days ago)
US11135216	INDIVIOR	Sublingual and buccal film compositions	Aug, 2029 (5 years from now)
US9687454	INDIVIOR	Sublingual and buccal film compositions	Aug, 2029 (5 years from now)
US8475832	INDIVIOR	Sublingual and buccal film compositions	Mar, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	Aug 30, 2013

Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ingredient

Market Authorisation Date: 30 August, 2010

Treatment: Treatment of opioid dependence/sublingual or buccal application; Treating opioid use disorder; This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence

Dosage: FILM;BUCCAL, SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
500 mg/vial	26 Jan, 2009	2	24 Mar, 2009	31 Jul, 2018	Eligible
2 mg/0.5 mg* and 8 mg/2 mg	15 Oct, 2012	1		13 Feb, 2023	Extinguished
4 mg/1 mg	14 May, 2013	1		13 Feb, 2023	Extinguished
12 mg/3 mg	14 May, 2013	1		13 Feb, 2023	Extinguished