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 |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | 7,579,019 | ⤷ 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 | 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 |
➤ Subscribe | Buccal Film | 900 mcg | ➤ Subscribe | 2016-09-12 |
➤ Subscribe | Buccal Film | 75 mcg and 150 mcg | ➤ Subscribe | 2016-10-24 |
International Patents for Bdsi Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Taiwan | 201300392 | ⤷ Try a Trial |
Spain | 2746207 | ⤷ Try a Trial |
European Patent Office | 1889848 | ⤷ Try a Trial |
Hong Kong | 1131344 | ⤷ Try a Trial |
Poland | 2851075 | ⤷ Try a Trial |
Denmark | 2851075 | ⤷ Try a Trial |
Japan | 2022058678 | ⤷ 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 | 2019/038 | Ireland | ⤷ Try a Trial | 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 | 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 | 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 | SPC/GB19/050 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT; REGISTERED: UK EU/1/18/1291(FOR NI) 20190220; UK PLGB 50999/0003 20190220 |
1889848 | 1990036-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220 |
1889848 | CR 2019 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220 |
1889848 | 132019000000093 | Italy | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.