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.
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 | 207932-001 | 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 | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | 6,159,498 | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | 6,159,498 | ⤷ 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 | 207932-004 | 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 | 6657454 | ⤷ Try a Trial |
Australia | 2012358308 | ⤷ Try a Trial |
European Patent Office | 3067044 | ⤷ Try a Trial |
Eurasian Patent Organization | 201991223 | ⤷ Try a Trial |
China | 110123792 | ⤷ Try a Trial |
Cyprus | 1117450 | ⤷ 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 | 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 |
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 | 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 |
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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.