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.
Drugs and US Patents for Bdsi
Expired US Patents for Bdsi
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | 6,159,498 | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-007 | Oct 23, 2015 | 7,579,019 | ⤷ Try a Trial |
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | 7,579,019 | ⤷ Try a Trial |
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | 7,579,019 | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | 6,159,498 | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | 6,159,498 | ⤷ Try a Trial |
>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 | 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 |
➤ 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 |
International Patents for Bdsi Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2017193563 | ⤷ Try a Trial |
Hong Kong | 1131344 | ⤷ Try a Trial |
European Patent Office | 1968539 | ⤷ Try a Trial |
Taiwan | 200726470 | ⤷ Try a Trial |
Taiwan | I545124 | ⤷ Try a Trial |
Russian Federation | 2019118034 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Bdsi Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1889848 | 122019000063 | Germany | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218 |
1889848 | C201930045 | Spain | ⤷ Try a Trial | PRODUCT NAME: NADELMEDINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218 |
1889848 | C 2019 033 | Romania | ⤷ Try a Trial | 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 | 19C1042 | France | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SOLVATES, EN PARTICULIER LE SEL DE TOSYLATE; REGISTRATION NO/DATE: EU/1/18/1291 20190220 |
1889848 | 2019C/533 | Belgium | ⤷ Try a Trial | 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 | 38/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSBESONDERE DAS TOSYLATSALZ; REGISTRATION NO/DATE: EU/1/18/1291 (MITTEILUNG) 20190220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.