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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.
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-two 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: | 64 |
| 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 | ||
| 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 |
|---|---|---|
| Japan | 2005536443 | ➤ Sign Up |
| Argentina | 078417 | ➤ Sign Up |
| European Patent Office | 3031445 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
