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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: September 21, 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 9,901,539 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No 8,703,177 ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes 9,522,188 ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes 7,579,019 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No 9,655,843 ➤ Sign Up Y ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 DISCN No No 9,597,288 ➤ 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

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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 207932-003 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 6,159,498 ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009 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 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

Non-Orange Book US Patents for Bdsi

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces ➤ Sign Up
2,017,035,688 ➤ Sign Up
6,159,498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Bdsi Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00522 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2014000024 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2006000022 Germany ➤ Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
C/GB06/022 United Kingdom ➤ Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
00521 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
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.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

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

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