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PROBUPHINE Drug Profile
» See Plans and Pricing
Which patents cover Probuphine, and what generic alternatives are available?
Probuphine is a drug marketed by Titan Pharms and is included in one NDA. There is one patent protecting this drug.
This drug has sixteen patent family members in thirteen countries.
The generic ingredient in PROBUPHINE is buprenorphine 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 profile page.
US ANDA Litigation and Generic Entry Outlook for Probuphine
A generic version of PROBUPHINE was approved as buprenorphine hydrochloride by HOSPIRA on June 3rd, 1996.
Summary for PROBUPHINE
| International Patents: | 16 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 9 |
| Clinical Trials: | 7 |
| Patent Applications: | 4,637 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROBUPHINE |
| DailyMed Link: | PROBUPHINE at DailyMed |
Recent Clinical Trials for PROBUPHINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Braeburn Pharmaceuticals | Phase 3 |
| National Institute on Drug Abuse (NIDA) | Phase 3 |
| Titan Pharmaceuticals | Phase 3 |
Pharmacology for PROBUPHINE
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
US Patents and Regulatory Information for PROBUPHINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Titan Pharms | PROBUPHINE | buprenorphine hydrochloride | IMPLANT;IMPLANTATION | 204442-001 | May 26, 2016 | DISCN | Yes | No | Start Trial | Start Trial | 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 PROBUPHINE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4668611 | Start Trial |
| Spain | 2665999 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03101358 | Start Trial |
| European Patent Office | 2561860 | Start Trial |
| Cyprus | 1120510 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
