PROBUPHINE Drug Patent Profile
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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. Seventeen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
DrugPatentWatch® 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 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 8 |
| Patent Applications: | 3,991 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROBUPHINE |
| What excipients (inactive ingredients) are in PROBUPHINE? | PROBUPHINE excipients list |
| DailyMed Link: | PROBUPHINE at DailyMed |
Recent Clinical Trials for PROBUPHINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 2 |
| Braeburn Pharmaceuticals | Phase 3 |
| National Institute on Drug Abuse (NIDA) | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for PROBUPHINE
US Patents and Regulatory Information for PROBUPHINE
PROBUPHINE is protected by one US patents.
Patents protecting PROBUPHINE
Implantable polymeric device for sustained release of buprenorphine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR OPIOID DEPENDENCE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
See the table below for patents covering PROBUPHINE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2008212011 | Implantable polymeric device for sustained release of buprenorphine | ⤷ Try a Trial |
| New Zealand | 536965 | Nonerodible polymeric matrix with buprenorphine encapsulated for the treatment of opiate addiction and pain | ⤷ Try a Trial |
| Mexico | PA04011875 | DISPOSITIVO POLIMERICO IMPLANTABLE PARA LIBERACION SOSTENIDA DE BUPRENORFINA. (IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF BUPRENORPHINE.) | ⤷ Try a Trial |
| Portugal | 2561860 | ⤷ Try a Trial | |
| Spain | 2665999 | ⤷ Try a Trial | |
| Cyprus | 1120510 | ⤷ Try a Trial | |
| Japan | 2005528422 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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