Bdsi Company Profile

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BDSI has three approved drugs.

There are nine US patents protecting BDSI drugs.

There are one hundred and seventy-six patent family members on BDSI drugs in thirty-three countries and thirteen supplementary protection certificates in twelve countries.

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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	9,655,843	⤷ Sign Up	Y			⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	9,655,843	⤷ Sign Up	Y			⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-002	Oct 23, 2015		RX	Yes	No	9,655,843	⤷ Sign Up	Y			⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	8,147,866	⤷ 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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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	6,159,498	⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	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	207932-001	Oct 23, 2015	6,159,498	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	2019/038	Ireland	⤷ Sign Up	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	C201930045	Spain	⤷ Sign Up	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	132019000000093	Italy	⤷ Sign Up	PRODUCT NAME: NALDEMEDINA O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SALE TOSILATO(RIZMOIC - NALDEMEDINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1291, 20190220
1889848	CR 2019 00035	Denmark	⤷ Sign Up	PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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