BDSI Company Profile
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What is the competitive landscape for BDSI, and when can generic versions of BDSI drugs launch?
BDSI has three approved drugs.
There are nine US patents protecting BDSI drugs.
There are one hundred and seventy-six patent family members on BDSI drugs in thirty-three countries and thirteen supplementary protection certificates in twelve countries.
Summary for BDSI
| International Patents: | 176 |
| US Patents: | 9 |
| Tradenames: | 3 |
| Ingredients: | 3 |
| NDAs: | 3 |
Drugs and US Patents for BDSI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | DISCN | Yes | No | 8,703,177 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | DISCN | Yes | No | 9,655,843 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | RX | Yes | No | 9,901,539 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | RX | Yes | No | 8,147,866 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | RX | Yes | No | 9,655,843 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | RX | Yes | No | 9,655,843 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | RX | Yes | No | 9,901,539 | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 BDSI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | 7,579,019 | ⤷ Sign Up |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | 7,579,019 | ⤷ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | 7,579,019 | ⤷ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | 7,579,019 | ⤷ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | 7,579,019 | ⤷ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | 6,159,498 | ⤷ Sign Up |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | 7,579,019 | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for BDSI drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Buccal Film | 300 mcg, 450 mcg, 600 mcg and 750 mcg | ➤ Subscribe | 2016-10-04 |
| ➤ Subscribe | Buccal Film | 6.3 mg/1 mg | ➤ Subscribe | 2015-12-21 |
| ➤ Subscribe | Buccal Film | 900 mcg | ➤ Subscribe | 2016-09-12 |
| ➤ Subscribe | Buccal Film | 75 mcg and 150 mcg | ➤ Subscribe | 2016-10-24 |
| ➤ Subscribe | Buccal Film | 2.1mg/0.3 mg and 4.2 mg/0.7 mg | ➤ Subscribe | 2016-11-23 |
International Patents for BDSI Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 033256 | ⤷ Sign Up |
| Australia | 2006326377 | ⤷ Sign Up |
| China | 101511337 | ⤷ Sign Up |
| Russian Federation | 2607084 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006126529 | ⤷ Sign Up |
| Russian Federation | 2019118034 | ⤷ Sign Up |
| Denmark | 2851075 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BDSI Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1889848 | 2019C/533 | Belgium | ⤷ Sign Up | PRODUCT NAME: NALMEDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN BIJZONDER HET TOSYLAATZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1291 20190220 |
| 1889848 | 122019000063 | Germany | ⤷ Sign Up | PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218 |
| 1889848 | 132019000000093 | Italy | ⤷ Sign Up | PRODUCT NAME: NALDEMEDINA O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SALE TOSILATO(RIZMOIC - NALDEMEDINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1291, 20190220 |
| 1889848 | CA 2019 00035 | Denmark | ⤷ Sign Up | PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220 |
| 1889848 | C 2019 033 | Romania | ⤷ Sign Up | PRODUCT NAME: NALDEMEDINA SAU O SARE SAU SOLVAT ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF NATIONAL AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218 |
| 1889848 | 2019/038 | Ireland | ⤷ Sign Up | PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218 |
| 1889848 | 1990036-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
