Pharsight

1. Bunavail patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9522188	December, 2012	Decision	Andrew Finn et al

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).
US6159498	BDSI	Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces	Oct, 2016 (7 years ago)
US7579019	BDSI	Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces	Jan, 2020 (4 years ago)
US9655843	BDSI	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)
US8147866	BDSI	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)
US8703177	BDSI	Abuse-resistant mucoadhesive devices for delivery of buprenorphine	Aug, 2032 (8 years from now)
US9522188	BDSI	Abuse resistant transmucosal drug delivery device	Apr, 2035 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jun 06, 2017

Market Authorisation Date: 06 June, 2014

Treatment: Maintenance treatment of opioid dependence; Treatment of opioid dependence

Dosage: FILM;BUCCAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.1 mg/0.3 mg and 4.2 mg/0.7 mg	23 Nov, 2016	1		20 Aug, 2032
6.3 mg/1 mg	21 Dec, 2015	1		20 Aug, 2032

Strength	Dosage	Availability
EQ 6.3MG BASE;EQ 1MG BASE	FILM;BUCCAL	Discontinued
EQ 2.1MG BASE;EQ 0.3MG BASE	FILM;BUCCAL	Discontinued
EQ 4.2MG BASE;EQ 0.7MG BASE	FILM;BUCCAL	Discontinued

BUNAVAIL family patents

2. 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).
US9931305	INDIVIOR	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Feb, 2022 (2 years ago)
US9855221	INDIVIOR	Uniform films for rapid-dissolve dosage form incorporating anti-tacking 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 (23 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

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

Strength	Dosage	Availability
EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription
EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription
EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription
EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription

SUBOXONE family patents

3. Zubsolv patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP12775283A	2015-12-04	Generics (U.K.) Limited	Opposition procedure closed
EP07824784A	2014-08-06	Generics [UK] Limited	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).
US8454996	OREXO US INC	Pharmaceutical composition for the treatment of acute disorders	Sep, 2019 (4 years ago)
US8658198	OREXO US INC	Non-abusable pharmaceutical composition comprising opioids	Dec, 2027 (3 years from now)
US8470361	OREXO US INC	Non-abusable pharmaceutical composition comprising opioids	May, 2030 (6 years from now)
US10946010	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US11020388	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US11020387	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US9259421	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US10874661	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US11433066	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US8940330	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)
US9439900	OREXO US INC	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence	Sep, 2032 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-713)	Aug 10, 2018

Market Authorisation Date: 04 October, 2016

Treatment: Sublingual administration of a pharmaceutical composition comprising buprenorphine; Sublingual or buccal administration of a pharmaceutical composition comprising buprenorphine and naloxone; Sublingua...

Dosage: TABLET;SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
1.4 mg/0.36 mg and 5.7 mg/1.4 mg	22 Oct, 2013	1	22 May, 2030
8.6 mg/2.1 mg and 11.4 mg/2.9 mg	24 Jul, 2015	1	18 Sep, 2032
2.9 mg/7.1 mg	21 Dec, 2015	1	18 Sep, 2032
0.7 mg/0.18 mg	04 May, 2017	1	18 Sep, 2032

Pharsight

Drugs that contain Buprenorphine Hydrochloride; Naloxone Hydrochloride

1. Bunavail patents expiration

BUNAVAIL family patents

2. Suboxone patents expiration

SUBOXONE family patents

3. Zubsolv patents expiration

ZUBSOLV family patents

Related content

Strength	Dosage	Availability
EQ 1.4MG BASE;EQ 0.36MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 5.7MG BASE;EQ 1.4MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET;SUBLINGUAL	Prescription