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Last Updated: May 27, 2024

Bdsi Company Profile


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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 9,901,539 ⤷  Sign Up ⤷  Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 RX Yes No 8,147,866 ⤷  Sign Up Y ⤷  Sign Up
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes 9,108,975 ⤷  Sign Up Y 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 BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 DISCN Yes No 9,655,843 ⤷  Sign Up Y ⤷  Sign Up
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes RE46375 ⤷  Sign Up Y Y ⤷  Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 DISCN Yes No 8,147,866 ⤷  Sign Up Y ⤷  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

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

Supplementary Protection Certificates for Bdsi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 C201930045 Spain ⤷  Sign Up 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 CR 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 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 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 19C1042 France ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.