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Details for Patent: 9,439,900

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Patent 9,439,900 protects ZUBSOLV and is included in one NDA. There have been three Paragraph IV challenges on Zubsolv.

This patent has twenty-two patent family members in twenty-three countries.

Summary for Patent: 9,439,900

Title:Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Abstract: There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are useful in the treatment of opioid dependency/addiction and/or pain.
Inventor(s): Fischer; Andreas (Uppsala, SE)
Assignee: Orexo AB (Uppsala, SE)
Application Number:14/577,823
Patent Claim Types:
see list of patent claims
Composition; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-006Oct 4, 2016RXNo9,439,900► subscribeY
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXNo9,439,900► subscribeY
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-005Jun 4, 2015RXNo9,439,900► subscribeY
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Non-Orange Book Patents for Patent: 9,439,900

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
8,940,330Abuse-resistant pharmaceutical composition for the treatment of opioid dependence► subscribe
9,259,421Abuse-resistant pharmaceutical composition for the treatment of opioid dependence► 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: 9,439,900

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2012311293► subscribe
Canada2834327► subscribe
Chile2014000575► 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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