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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Dow
Mallinckrodt
Johnson and Johnson
Colorcon

Last Updated: November 30, 2021

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BDSI Company Profile


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Summary for BDSI
International Patents:194
US Patents:16
Tradenames:5
Ingredients:5
NDAs:5

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 207932-005 Oct 23, 2015 AB RX Yes No 9,655,843 ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes RE46365 ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 DISCN Yes No 8,147,866 ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 AB RX Yes No 8,147,866 ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 AB RX Yes No 9,655,843 ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bdsi ELYXYB celecoxib SOLUTION;ORAL 212157-001 May 5, 2020 DISCN Yes No 9,795,620 ⤷  Free Forever Trial Y ⤷  Free Forever 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 BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 6,159,498 ⤷  Free Forever Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 6,159,498 ⤷  Free Forever Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 7,579,019 ⤷  Free Forever Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 6,159,498 ⤷  Free Forever Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 7,579,019 ⤷  Free Forever Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 7,579,019 ⤷  Free Forever 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

Supplementary Protection Certificates for BDSI Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 300996 Netherlands ⤷  Free Forever 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 ⤷  Free Forever Trial PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1635783 C300653 Netherlands ⤷  Free Forever Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511 SPC/GB06/022 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1769785 C300521 Netherlands ⤷  Free Forever Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1889848 CR 2019 00035 Denmark ⤷  Free Forever Trial PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
>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.

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Express Scripts
Baxter
Medtronic
Johnson and Johnson

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.