DrugPatentWatch Database Preview
SUBOXONE Drug Profile
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 seven patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and sixty-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: | 165 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 4 |
| Clinical Trials: | 71 |
| 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 |
|---|---|
| Massachusetts General Hospital | Phase 4 |
| The EMMES Corporation | Phase 3 |
| Theresa Winhusen, PhD | Phase 3 |
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. Actavis Laboratories UT, Inc. | 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 |
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 | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for SUBOXONE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Sulingual Film | 12 mg/3 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Sublingual Film | 2 mg/0.5 mg and 8 mg/2 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Sublingual Film | 4 mg/1 mg | ➤ Subscribe | Start Trial |
International Patents for SUBOXONE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3326612 | Start Trial |
| China | 1812773 | Start Trial |
| Australia | 2006322050 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
