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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Julphar
US Department of Justice
AstraZeneca
Harvard Business School
Medtronic
Teva
McKesson
Moodys
Mallinckrodt

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,486,993

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Which drugs does patent 8,486,993 protect, and when does it expire?


Patent 8,486,993 protects ENVARSUS XR and is included in one NDA.

This patent has twenty-eight patent family members in fifteen countries.

Summary for Patent: 8,486,993

Title:Solid dispersions comprising tacrolimus
Abstract: A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.
Inventor(s): Holm; Per (Vanlose, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:13/178,280
Patent Claim Types:
see list of patent claims
Composition; Process; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Veloxis Pharms IncENVARSUS XRtacrolimusTABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXYesNo► Subscribe► Subscribe► SubscribeYPROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms IncENVARSUS XRtacrolimusTABLET, EXTENDED RELEASE;ORAL206406-002Jul 10, 2015RXYesNo► Subscribe► Subscribe► SubscribeYPROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms IncENVARSUS XRtacrolimusTABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYesYes► Subscribe► Subscribe► SubscribeYPROPHYLAXIS OF ORGAN REJECTION
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Foreign Priority and PCT Information for Patent: 8,486,993

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003 01232Aug 29, 2003
Denmark2003 01837Dec 11, 2003
Denmark2004 00079Jan 21, 2004
Denmark2004 00463Mar 23, 2004
Denmark2004 00467Mar 23, 2004

Non-Orange Book Patents for Patent: 8,486,993

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
9,763,920Solid dispersions comprising tacrolimus► Subscribe
7,994,214Solid dispersions comprising tacrolimus► Subscribe
8,623,410Modified release compositions comprising tacrolimus► Subscribe
9,757,362Modified release compositions comprising tacrolimus► Subscribe
8,889,185Modified release compositions comprising tacrolimus► Subscribe
8,617,599Modified release compositions comprising tacrolimus► Subscribe
8,623,411Modified release compositions comprising tacrolimus► Subscribe
8,889,186Modified release compositions comprising tacrolimus► Subscribe
8,591,946Modified release compositions comprising tacrolimus► Subscribe
9,161,907Modified release compositions comprising tacrolimus► 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 Patent: 8,486,993

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
BrazilPI0414000► Subscribe
Canada2537041► Subscribe
Canada2537044► Subscribe
China1859909► Subscribe
China1859910► Subscribe
China101869561► Subscribe
Germany602004028023► Subscribe
Denmark1663216► Subscribe
Denmark1663217► Subscribe
European Patent Office1663216► 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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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Novartis
Johnson and Johnson
Fuji
Covington
Deloitte
AstraZeneca
Julphar
Medtronic

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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