BELBUCA Drug Patent Profile
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Which patents cover Belbuca, and when can generic versions of Belbuca launch?
Belbuca is a drug marketed by Bdsi and is included in one NDA. There are three patents protecting this drug and three Paragraph IV challenges.
This drug has seventy-five patent family members in twenty-seven countries.
The generic ingredient in BELBUCA 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Belbuca
A generic version of BELBUCA was approved as buprenorphine hydrochloride by HOSPIRA on June 3rd, 1996.
Summary for BELBUCA
| International Patents: | 75 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 9 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BELBUCA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BELBUCA |
| What excipients (inactive ingredients) are in BELBUCA? | BELBUCA excipients list |
| DailyMed Link: | BELBUCA at DailyMed |
Recent Clinical Trials for BELBUCA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Carolinas Pain Institute | Phase 4 |
| BioDelivery Sciences International | Phase 4 |
| Medical College of Wisconsin | Phase 2 |
Pharmacology for BELBUCA
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BELBUCA
Paragraph IV (Patent) Challenges for BELBUCA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BELBUCA | Buccal Film | buprenorphine hydrochloride | 75 mcg and 150 mcg | 207932 | 1 | 2016-10-24 |
| BELBUCA | Buccal Film | buprenorphine hydrochloride | 300 mcg, 450 mcg, 600 mcg and 750 mcg | 207932 | 1 | 2016-10-04 |
| BELBUCA | Buccal Film | buprenorphine hydrochloride | 900 mcg | 207932 | 1 | 2016-09-12 |
US Patents and Regulatory Information for BELBUCA
BELBUCA is protected by three US patents.
Patents protecting BELBUCA
Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Transmucosal drug delivery devices for use in chronic pain relief
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | RX | 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 |
Expired US Patents for BELBUCA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BELBUCA
See the table below for patents covering BELBUCA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20190110628 | 만성 통증 완화에 이용되는 점막 관통 약물 전달 장치 (TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF) | ⤷ Try a Trial |
| Serbia | 54764 | SREDSTVO ZA TRANSMUKOZALNU ISPORUKU SA POVEĆANIM NAKUPLJANJEM (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) | ⤷ Try a Trial |
| Brazil | 112014015329 | dispositivos de liberação de droga transmucosa para uso em alívio de dor crônica | ⤷ Try a Trial |
| Slovenia | 2054031 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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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