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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
McKinsey
Dow
Merck
Boehringer Ingelheim

Last Updated: January 28, 2020

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Bdsi Company Profile

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Summary for Bdsi
International Patents:175
US Patents:10
Tradenames:4
Ingredients:4
NDAs:4

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 RX Yes No 8,147,866   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No 9,901,539   Start Trial   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 DISCN No No 9,597,288   Start Trial Y   Start 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 205637-002 Jun 6, 2014 7,579,019   Start Trial
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 6,159,498   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 6,159,498   Start 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

Supplementary Protection Certificates for Bdsi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0901368 C300523 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1889848 300996 Netherlands   Start 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
>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:

McKesson
Mallinckrodt
Colorcon
Express Scripts
Dow
Boehringer Ingelheim

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 verifification 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.