SUBOXONE Drug Patent 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 eight patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and ninety-three patent family members in twenty-six 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Suboxone
A generic version of SUBOXONE was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22nd, 2013.
Summary for SUBOXONE
| International Patents: | 193 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 30 |
| Clinical Trials: | 94 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUBOXONE |
| Drug Sales Revenues: | Drug sales revenues for SUBOXONE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUBOXONE |
| What excipients (inactive ingredients) are in SUBOXONE? | SUBOXONE excipients list |
| DailyMed Link: | SUBOXONE at DailyMed |
Recent Clinical Trials for SUBOXONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Indivior Inc. | Phase 1 |
| Wake Forest University Health Sciences | Phase 2 |
| National Institute of Drug Abuse | Phase 2 |
Pharmacology for SUBOXONE
| Drug Class | Opioid Antagonist Partial Opioid Agonist |
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SUBOXONE
Paragraph IV (Patent) Challenges for SUBOXONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SUBOXONE | Sublingual Film | buprenorphine hydrochloride; naloxone hydrochloride | 12 mg/3 mg | 022410 | 1 | 2013-05-14 |
| SUBOXONE | Sublingual Film | buprenorphine hydrochloride; naloxone hydrochloride | 2 mg/0.5 mg* and 8 mg/2 mg | 022410 | 1 | 2012-10-15 |
| SUBOXONE | for Injection | buprenorphine hydrochloride; naloxone hydrochloride | 500 mg/vial | 020733 | 2 | 2009-01-26 |
US Patents and Regulatory Information for SUBOXONE
SUBOXONE is protected by eight US patents.
Patents protecting SUBOXONE
Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID USE DISORDER
Polyethylene oxide-based films and drug delivery systems made therefrom
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | 022410-004 | Aug 10, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-004 | Aug 10, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 020733-001 | Oct 8, 2002 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SUBOXONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | See Plans and Pricing | See Plans and Pricing |
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-002 | Aug 30, 2010 | See Plans and Pricing | See Plans and Pricing |
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-001 | Aug 30, 2010 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SUBOXONE
When does loss-of-exclusivity occur for SUBOXONE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8417
Estimated Expiration: See Plans and Pricing
Australia
Patent: 10279440
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2012002817
Estimated Expiration: See Plans and Pricing
Canada
Patent: 70180
Estimated Expiration: See Plans and Pricing
Chile
Patent: 12000313
Estimated Expiration: See Plans and Pricing
China
Patent: 2548535
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 11219
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0160368
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 61795
Estimated Expiration: See Plans and Pricing
Patent: 31445
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 61795
Estimated Expiration: See Plans and Pricing
Patent: 31445
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 71960
Estimated Expiration: See Plans and Pricing
Israel
Patent: 7964
Estimated Expiration: See Plans and Pricing
Patent: 4974
Estimated Expiration: See Plans and Pricing
Japan
Patent: 19827
Estimated Expiration: See Plans and Pricing
Patent: 13501717
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 6006
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 12001573
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 8537
Estimated Expiration: See Plans and Pricing
Peru
Patent: 121136
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 12108632
Estimated Expiration: See Plans and Pricing
Patent: 18121855
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 8265
Estimated Expiration: See Plans and Pricing
Patent: 201601214V
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1201647
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1699321
Estimated Expiration: See Plans and Pricing
Patent: 120059538
Estimated Expiration: See Plans and Pricing
Spain
Patent: 62634
Estimated Expiration: See Plans and Pricing
Patent: 57814
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering SUBOXONE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2002362772 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2008100375 | See Plans and Pricing | |
| Canada | 2468557 | EMBALLAGE DESTINE DES COMPOSANTS ELECTRO-OPTIQUES (PACKAGE FOR ELECTRO-OPTICAL COMPONENTS) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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