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 six patents protecting this drug and three Paragraph IV challenges.
The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for SUBOXONE
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 4 |
| Clinical Trials: | 63 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUBOXONE |
| 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 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-002 | Aug 30, 2010 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-004 | Aug 10, 2012 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-001 | Aug 30, 2010 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| 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 | ➤ Sign Up |
| ➤ Subscribe | Sublingual Film | 2 mg/0.5 mg and 8 mg/2 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Sublingual Film | 4 mg/1 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for SUBOXONE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2473970 | ➤ Sign Up |
| Spain | 2562634 | ➤ Sign Up |
| Canada | 2473975 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007067494 | ➤ Sign Up |
| Japan | 2011140507 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
