Pharsight

1. Belbuca 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).
US8147866	BDSI	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)
US9655843	BDSI	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)
US9901539	BDSI	Transmucosal drug delivery devices for use in chronic pain relief	Dec, 2032 (9 years from now)

Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE ingredient

Market Authorisation Date: 23 October, 2015

Treatment: Treatement of pain by transmucosal delivery of buprenorphine; Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment option...

Dosage: FILM;BUCCAL

Strength	Submission Date	ANDA(s) Filed	Last patent expiry	180 day status
75 mcg and 150 mcg	24 Oct, 2016	1	23 Jul, 2027	Extinguished Non-Forfeiture
300 mcg, 450 mcg, 600 mcg and 750 mcg	04 Oct, 2016	1	23 Jul, 2027	Extinguished Non-Forfeiture
900 mcg	12 Sep, 2016	1	23 Jul, 2027	Extinguished Non-Forfeiture

Strength	Dosage	Availability
EQ 0.075MG BASE	FILM;BUCCAL	Prescription
EQ 0.15MG BASE	FILM;BUCCAL	Prescription
EQ 0.3MG BASE	FILM;BUCCAL	Prescription
EQ 0.45MG BASE	FILM;BUCCAL	Prescription
EQ 0.6MG BASE	FILM;BUCCAL	Prescription
EQ 0.75MG BASE	FILM;BUCCAL	Prescription
EQ 0.9MG BASE	FILM;BUCCAL	Prescription

BELBUCA family patents

2. 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).
US8147866	BDSI	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)
US9655843	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 (11 years from now)

Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ingredient

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

BUNAVAIL family patents

3. Elyxyb 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).
US9572819	BDSI	Oral composition of celecoxib for treatment of pain	May, 2036 (12 years from now)
US10376527	BDSI	Oral composition of celecoxib for treatment of pain	May, 2036 (12 years from now)
US9949990	BDSI	Oral composition of celecoxib for treatment of pain	May, 2036 (12 years from now)
US10722456	BDSI	Oral composition of celecoxib for treatment of pain	May, 2036 (12 years from now)
US10799517	BDSI	Oral composition of celecoxib for treatment of pain	May, 2036 (12 years from now)
US9795620	BDSI	Oral composition of celecoxib for treatment of pain	May, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product (NP)	May 5, 2023

Drugs and Companies using CELECOXIB ingredient

Market Authorisation Date: 05 May, 2020

Treatment: Acute treatment of migraine with or without aura in adults

Dosage: SOLUTION;ORAL

Strength	Dosage	Availability
25MG/ML	SOLUTION;ORAL	Prescription

ELYXYB family patents

4. Onsolis 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).
US9597288	BDSI	Transmucosal delivery devices with enhanced uptake	Jul, 2027 (3 years from now)

Drugs and Companies using FENTANYL CITRATE ingredient

Market Authorisation Date: 16 July, 2009

Treatment: Management of breakthrough pain in patients with cancer

Dosage: FILM;BUCCAL

Strength	Dosage	Availability
EQ 0.2MG BASE	FILM;BUCCAL	Discontinued
EQ 0.4MG BASE	FILM;BUCCAL	Discontinued
EQ 0.6MG BASE	FILM;BUCCAL	Discontinued
EQ 0.8MG BASE	FILM;BUCCAL	Discontinued
EQ 1.2MG BASE	FILM;BUCCAL	Discontinued

ONSOLIS family patents

5. Symproic patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE46375	BDSI	6,7-unsaturated-7-carbamoyl substituted morphinan derivative	Oct, 2026 (3 years from now)
USRE46365	BDSI	6,7-unsaturated-7-carbamoyl substituted morphinan derivative	Jan, 2028 (4 years from now)
US9108975	BDSI	Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same	Nov, 2031 (8 years from now)
US10952968	BDSI	Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives	May, 2033 (9 years from now)