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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Moodys
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Mallinckrodt
UBS
Accenture
Teva

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,557,291

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Which drugs does patent 8,557,291 protect, and when does it expire?

Patent 8,557,291 protects XTAMPZA ER and is included in one NDA.

This patent has fifteen patent family members in nine countries.
Summary for Patent: 8,557,291
Title:Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In a preferred embodiment, a drug is modified to increase its lipophilicity. In some embodiments the modified drug is homogeneously dispersed within spherical microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and/or organic solvent insoluble. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Inventor(s): Rariy; Roman V. (Allston, MA), Fleming; Alison B. (Attleboro, MA), Hirsh; Jane (Wellesley, MA), Klibanov; Alexander M. (Boston, MA)
Assignee: Collegium Pharmaceutical, Inc. (Canton, MA)
Application Number:12/473,073
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,557,291
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Formulation;

Drugs Protected by US Patent 8,557,291

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No ➤ Sign Up ➤ 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. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,557,291

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
8,758,813 Abuse-deterrent drug formulations ➤ Sign Up
9,044,398 Abuse-deterrent pharmaceutical compositions of opiods and other drugs ➤ Sign Up
9,248,195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs ➤ Sign Up
7,399,488 Abuse-deterrent pharmaceutical compositions of opiods and other drugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Argus Health
Moodys
Healthtrust
Harvard Business School
Johnson and Johnson
Deloitte
Queensland Health
US Department of Justice

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