DrugPatentWatch Database Preview
SUBOXONE Drug Profile
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When do Suboxone patents expire, and when can generic versions of Suboxone launch?
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-three 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: | 5 |
| 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 |
Generic Entry Opportunity Date for SUBOXONE
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 |
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 |
|---|---|---|
| 8,765,167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions | ➤ Sign Up |
| 7,824,588 | Method of making self-supporting therapeutic active-containing film | ➤ Sign Up |
| 7,897,080 | Polyethylene-oxide based films and drug delivery systems made therefrom | ➤ Sign Up |
| 2,016,206,639 | ➤ Sign Up | |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for SUBOXONE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006039264 | ➤ Sign Up |
| Japan | 6035369 | ➤ Sign Up |
| Australia | 2010214780 | ➤ Sign Up |
| Japan | 2011068689 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
