Pharsight

1. Nucynta patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7994364	January, 2016	Terminated-Denied	Gruenenthal GmbH	Rosellini Scientific, LLC

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.
USRE39593	COLLEGIUM PHARM INC	1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects	Aug, 2022 (1 year, 1 month ago)
US7994364	COLLEGIUM PHARM INC	Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride	Jun, 2025 (1 year, 9 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population (NPP)	Jul 3, 2026

Drugs and Companies using TAPENTADOL HYDROCHLORIDE ingredient

Market Authorisation Date: 15 October, 2012

Treatment: Relief of moderate to severe acute pain; Management of moderate to severe acute pain

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg, 75 mg, and 100 mg	20 Nov, 2012	4		27 Jun, 2025
20 mg/mL	20 Dec, 2013	1		27 Jun, 2025

Strength	Dosage	Availability
EQ 20MG BASE/ML	SOLUTION;ORAL	Discontinued

NUCYNTA family patents

2. Nucynta Er patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06706682A	2017-12-19	G. L. Pharma GmbH	Revoked
EP08749016A	2012-08-23	Generics [UK] Limited	Revoked
EP2005006983W	2009-10-13	Sanofi-Aventis Deutschland GmbH	Patent maintained as amended
EP2005006983W	2009-10-13	Ypsomed AG	Patent maintained as amended
EP04763833A	2008-03-27	Purdue Pharma LP	Opposition rejected
EP04763834A	2007-12-14	Purdue Pharma LP	Opposition rejected

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7994364	January, 2016	Terminated-Denied	Gruenenthal GmbH	Rosellini Scientific, LLC

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.
USRE39593	COLLEGIUM PHARM INC	1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects	Aug, 2022 (1 year, 1 month ago)
US7994364	COLLEGIUM PHARM INC	Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride	Jun, 2025 (1 year, 9 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11007156	COLLEGIUM PHARM INC	Prolonged release pharmaceutical composition containing 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol	Oct, 2022 (11 months ago)
US8075872	COLLEGIUM PHARM INC	Abuse-proofed dosage form	Nov, 2023 (a month from now)
US8420056	COLLEGIUM PHARM INC	Abuse-proofed dosage form	Nov, 2023 (a month from now)
US8309060	COLLEGIUM PHARM INC	Abuse-proofed dosage form	Nov, 2023 (a month from now)
US8114383	COLLEGIUM PHARM INC	Abuse-proofed dosage form	Oct, 2024 (1 year, 16 days from now)
US11344512	COLLEGIUM PHARM INC	Titration of tapentadol	Apr, 2028 (4 years from now)
US8536130	COLLEGIUM PHARM INC	Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain	Sep, 2028 (4 years from now)

Drugs and Companies using TAPENTADOL HYDROCHLORIDE ingredient

Market Authorisation Date: 25 August, 2011

Treatment: Relief of moderate to severe chronic pain; Management of neuropathic pain associated with diabetic peripheral neuropathy; A method of titrating an opioid to manage pain severe enough to require daily,...

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg, 100 mg, 150 mg, 200 mg, and 250 mg	20 Nov, 2012	2		27 Jun, 2025

Strength	Dosage	Availability
EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 250MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription

NUCYNTA ER family patents

3. Xtampza Er 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).
US9763883	COLLEGIUM PHARM INC	Abuse-deterrent drug formulations	Jul, 2023 (2 months ago)
US9248195	COLLEGIUM PHARM INC	Abuse-deterrent pharmaceutical compositions of opioids and other drugs	Jul, 2023 (2 months ago)
US8840928	COLLEGIUM PHARM INC	Tamper-resistant pharmaceutical compositions of opioids and other drugs	Jul, 2023 (2 months ago)
US10525052	COLLEGIUM PHARM INC	Abuse-deterrent drug formulations	Jul, 2023 (2 months ago)
US9044398	COLLEGIUM PHARM INC	Abuse-deterrent pharmaceutical compositions of opiods and other drugs	Jul, 2023 (2 months ago)
US9592200	COLLEGIUM PHARM INC	Abuse-deterrent pharmaceutical compositions of opioids and other drugs	Jul, 2023 (2 months ago)
US10525053	COLLEGIUM PHARM INC	Abuse-deterrent pharmaceutical compositions of opioids and other drugs	Jul, 2023 (2 months ago)
US8557291	COLLEGIUM PHARM INC	Abuse-deterrent pharmaceutical compositions of opioids and other drugs	Mar, 2025 (1 year, 5 months from now)
US7399488	COLLEGIUM PHARM INC	Abuse-deterrent pharmaceutical compositions of opiods and other drugs	Mar, 2025 (1 year, 5 months from now)
US7771707	COLLEGIUM PHARM INC	Abuse-deterrent drug formulations	Mar, 2025 (1 year, 5 months from now)
US8449909	COLLEGIUM PHARM INC	Abuse-deterrent drug formulations	Mar, 2025 (1 year, 5 months from now)
US8758813	COLLEGIUM PHARM INC	Abuse-deterrent drug formulations	Jun, 2025 (1 year, 8 months from now)
US10668060	COLLEGIUM PHARM INC	Tamper-resistant pharmaceutical compositions of opioids and other drugs	Dec, 2030 (7 years from now)
US10004729	COLLEGIUM PHARM INC	Tamper-resistant pharmaceutical compositions of opioids and other drugs	Dec, 2030 (7 years from now)
US9682075	COLLEGIUM PHARM INC	Tamper-resistant pharmaceutical compositions of opioids and other drugs	Dec, 2030 (7 years from now)
US10188644	COLLEGIUM PHARM INC	Process of making stable abuse-deterrent oral formulations	Sep, 2036 (12 years from now)
US9968598	COLLEGIUM PHARM INC	Process of making stable abuse-deterrent oral formulations	Sep, 2036 (12 years from now)
US9737530	COLLEGIUM PHARM INC	Process of making stable abuse-deterrent oral formulations	Sep, 2036 (12 years from now)
US10646485	COLLEGIUM PHARM INC	Process of making stable abuse-deterrent oral formulations	Sep, 2036 (12 years from now)

Drugs and Companies using OXYCODONE ingredient

Market Authorisation Date: 26 April, 2016

Treatment: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg	15 Nov, 2017	1		02 Sep, 2036

Strength	Dosage	Availability
9MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
13.5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
18MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
27MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
36MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription