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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Deloitte
McKinsey
Cerilliant
Accenture
Johnson and Johnson
Chinese Patent Office
Cipla
Farmers Insurance

Generated: November 18, 2018

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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 seven US patents protecting BDSI drugs.

Summary for Bdsi
US Patents:7
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 7,579,019 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 RX Yes No 8,147,866 ➤ Sign Up Y ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 RX Yes No 8,147,866 ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No 7,579,019 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Bdsi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 6,159,498 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/022 United Kingdom ➤ Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
00653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00523 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2014 00016 Denmark ➤ Sign Up PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Citi
McKesson
UBS
Johnson and Johnson
Merck
Federal Trade Commission
Mallinckrodt
Cipla

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