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SUBOXONE Drug Profile
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» See Plans and PricingWhen 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 seven patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and seventy 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. Eighteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Suboxone
Annual sales in 2017 were $271mm indicating the motivation for generic entry.
There have been twenty-nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (buprenorphine hydrochloride; naloxone hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SUBOXONE
| International Patents: | 170 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 76 |
| 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 |
| DailyMed Link: | SUBOXONE at DailyMed |
Recent Clinical Trials for SUBOXONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emergency Medicine Foundation | Phase 4 |
| NYU Langone Health | Phase 4 |
| Ohio State University | Phase 4 |
Recent Litigation for SUBOXONE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| United States v. Indivior Inc. | 2019-04-09 |
| Indivior Inc. v. Aveva Drug Delivery Systems, Inc. | 2019-03-22 |
| INDIVIOR INC. v. ALVOGEN PINE BROOK LLC | 2018-04-03 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Dr. Reddy's Laboratories S.A. | 2018-11-13 |
| Dr. Reddy’s Laboratories S.A. | 2018-11-13 |
| Dr. Reddy’s Laboratories, Inc. | 2017-06-12 |
Pharmacology for SUBOXONE
| Drug Class | Partial Opioid Agonist Opioid Antagonist |
| Mechanism of Action | Partial Opioid Agonists Opioid Antagonists |
Paragraph IV (Patent) Challenges for SUBOXONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SUBOXONE | FILM;BUCCAL, SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 022410 | 2013-05-14 |
| SUBOXONE | FILM;BUCCAL, SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 022410 | 2012-10-15 |
| SUBOXONE | TABLET;SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 020733 | 2011-06-17 |
| SUBOXONE | TABLET;SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 020733 | 2009-01-26 |
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 | 022410-004 | Aug 10, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 020733-001 | Oct 8, 2002 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-001 | Aug 30, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-002 | Aug 30, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-004 | Aug 10, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SUBOXONE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2544776 | Start Trial |
| China | 102548535 | Start Trial |
| China | 105491997 | Start Trial |
| Japan | 4795962 | Start Trial |
| European Patent Office | 2568975 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
