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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Healthtrust
Fish and Richardson
Argus Health
Boehringer Ingelheim
Cantor Fitzgerald
US Department of Justice
Federal Trade Commission
AstraZeneca

Generated: February 21, 2018

DrugPatentWatch Database Preview

Bdsi Company Profile

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What is the competitive landscape for BDSI, and what generic alternatives to BDSI drugs are available?

BDSI has three approved drugs.

There are six US patents protecting BDSI drugs and there have been five Paragraph IV challenges on BDSI drugs in the past three years.

There are eighty-eight patent family members on BDSI drugs in twenty-nine countries and eleven supplementary protection certificates in four countries.

Summary for Bdsi
International Patents:88
US Patents:6
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 BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes 9,655,843 ➤ Sign Up Y ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 DISCN No No 7,579,019 ➤ Sign Up ➤ 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 207932-005 Oct 23, 2015 RX Yes No 7,579,019 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No 9,522,188 ➤ Sign Up Y ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 RX Yes Yes 9,655,843 ➤ Sign Up Y ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009 DISCN No No 7,579,019 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes 8,147,866 ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No 9,522,188 ➤ Sign Up Y ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No ➤ 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 207932-001 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-005 Jul 16, 2009 6,159,498 ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 6,159,498 ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 6,159,498 ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 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 022266-002 Jul 16, 2009 6,159,498 ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 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 2.1mg/0.3 mg and 4.2 mg/0.7 mg ➤ Subscribe 11/23/2016
➤ Subscribe Buccal Film 75 mcg and 150 mcg ➤ Subscribe 10/24/2016
➤ Subscribe Buccal Film 300 mcg, 450 mcg, 600 mcg and 750 mcg ➤ Subscribe 10/4/2016
➤ Subscribe Buccal Film 900 mcg ➤ Subscribe 9/12/2016
➤ Subscribe Buccal Film 6.3 mg/1 mg ➤ Subscribe 12/21/2015

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
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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International Patents for Bdsi Drugs

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
00523 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
00653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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
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
0653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2006000022 Germany ➤ Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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
2011000009 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 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.

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

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
AstraZeneca
Cipla
Colorcon
Mallinckrodt
Cerilliant
Fuji
QuintilesIMS

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.

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