Bdsi Company Profile

What is the competitive landscape for BDSI, and when can generic versions of BDSI drugs launch?

BDSI has four approved drugs.

There are fifteen US patents protecting BDSI drugs.

There are one hundred and ninety-eight patent family members on BDSI drugs in thirty-two countries and fourteen supplementary protection certificates in twelve countries.

Summary for Bdsi

International Patents:	198
US Patents:	15
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	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		DISCN	Yes	No
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No	8,703,177		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015		RX	Yes	No	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	Oct 23, 2015		RX	Yes	Yes	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	8,147,866		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015		RX	Yes	No	8,147,866		Y

Expired US Patents for Bdsi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-002	Oct 23, 2015	7,579,019
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	7,579,019
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015	7,579,019
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015	7,579,019
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014	7,579,019

Paragraph IV (Patent) Challenges for BDSI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Buccal Film	300 mcg, 450 mcg, 600 mcg and 750 mcg		2016-10-04
	Buccal Film	6.3 mg/1 mg		2015-12-21
	Buccal Film	900 mcg		2016-09-12
	Buccal Film	75 mcg and 150 mcg		2016-10-24
	Buccal Film	2.1mg/0.3 mg and 4.2 mg/0.7 mg		2016-11-23

International Patents for Bdsi Drugs

Country	Patent Number	Estimated Expiration
Australia	2007275581
South Korea	101329496
Taiwan	I545124
Israel	233075
Norway	20090278
South Korea	20190110628
European Patent Office	1968539

Supplementary Protection Certificates for Bdsi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	C201930045	Spain		PRODUCT NAME: NADELMEDINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
1889848	CR 2019 00035	Denmark		PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848	1990036-4	Sweden		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220
1889848	2019/038	Ireland		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	300996	Netherlands		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	19C1042	France		PRODUCT NAME: NALDEMEDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SOLVATES, EN PARTICULIER LE SEL DE TOSYLATE; REGISTRATION NO/DATE: EU/1/18/1291 20190220
1889848	SPC/GB19/050	United Kingdom		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT; REGISTERED: UK EU/1/18/1291(FOR NI) 20190220; UK PLGB 50999/0003 20190220

Similar Applicant Names

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

• Bdsi