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ONSOLIS Drug Profile

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Onsolis is a drug marketed by Biodelivery Sci Intl and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-seven patent family members in ten countries.

The generic ingredient in ONSOLIS is fentanyl citrate. There are thirty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for Tradename: ONSOLIS

Patents:2
Applicants:1
NDAs:1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-001Jul 16, 2009DISCNNo7,579,019► subscribe ► subscribe
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-004Jul 16, 2009DISCNNo7,579,019► subscribe ► subscribe
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-002Jul 16, 2009DISCNNo6,159,498► subscribeY ► subscribe
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Expired Patents for Tradename: ONSOLIS

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-004Jul 16, 20096,159,498► subscribe
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-001Jul 16, 20096,159,498► subscribe
Biodelivery Sci Intl
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-005Jul 16, 20096,159,498► subscribe
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Non-Orange Book Patents for Tradename: ONSOLIS

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► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ONSOLIS

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9817251► subscribe
Spain2188907► subscribe
Canada2329128► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ONSOLIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00016Denmark► subscribePRODUCT 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
00521Netherlands► subscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00523Netherlands► subscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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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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