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SUBOXONE Drug Profile

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When do Suboxone patents expire, and when can generic versions of Suboxone launch?

Suboxone is a drug marketed by Indivior Inc and is included in two NDAs. There are six patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in twenty-five countries.

The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for SUBOXONE

International Patents:	135
US Patents:	6
Applicants:	1
NDAs:	2
Suppliers / Packagers:	4
Clinical Trials:	60
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBOXONE
DailyMed Link:	SUBOXONE at DailyMed

Pharmacology for SUBOXONE

Drug Class	Partial Opioid Agonist Opioid Antagonist
Mechanism of Action	Partial Opioid Agonists Opioid Antagonists

US Patents and Regulatory Information for SUBOXONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010		RX	Yes	No			Y
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010		RX	Yes	No			Y
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012		RX	Yes	Yes			Y
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012		RX	Yes	No			Y

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Paragraph IV (Patent) Challenges for SUBOXONE

Drugname	Dosage	Strength	RLD	Submissiondate
	Sulingual Film	12 mg/3 mg		2014-03-26
	Sublingual Film	2 mg/0.5 mg and 8 mg/2 mg		2012-10-15
	Sublingual Film	4 mg/1 mg		2013-05-14

Non-Orange Book US Patents for SUBOXONE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,910,031	Process for forming an ingestible thin film with non-self-aggregating uniform heterogeneity
7,425,292	Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
2,016,206,639
9,108,340	Process for manufacturing a resulting multi-layer pharmaceutical film

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International Patents for SUBOXONE

Country	Document Number	Estimated Expiration
Canada	2473970
Peru	11362012
European Patent Office	2079457
Canada	2621263