Bdsi Company Profile
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What is the competitive landscape for BDSI, and what generic alternatives to BDSI drugs are available?
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 | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | RX | Yes | No | 8,147,866 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | DISCN | Yes | No | 9,655,843 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | DISCN | Yes | No | 8,147,866 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | DISCN | Yes | No | 8,147,866 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | DISCN | Yes | No | 9,655,843 | ⤷ Try a Trial | Y | ⤷ 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 Bdsi
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 207932-004 | 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 | 205637-002 | 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 |
| >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 |
|---|---|---|
| China | 105131003 | ⤷ Try a Trial |
| Taiwan | 201350120 | ⤷ Try a Trial |
| Japan | 5070364 | ⤷ Try a Trial |
| Russian Federation | 2009106177 | ⤷ Try a Trial |
| Portugal | 1889848 | ⤷ 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 | 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 | 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 |
| 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 | 300996 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDINE DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TOSYLAATZOUT; REGISTRATION NO/DATE: EU/1/18/1291 20190220 |
| 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 |
| >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.
