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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Chubb
Merck
Baxter
Accenture
Farmers Insurance
Medtronic
US Army

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,449,909

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Which drugs does patent 8,449,909 protect, and when does it expire?

Patent 8,449,909 protects XTAMPZA ER and is included in one NDA.

This patent has fifteen patent family members in nine countries.
Summary for Patent: 8,449,909
Title:Abuse-deterrent drug formulations
Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within 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 preferably organic solvent insoluble. The abuse-deterrent composition prevents the immediate release of a substantial portion 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 broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.
Inventor(s): Hirsh; Jane (Wellesley, MA), Fleming; Alison (Mansfield, MA), Rariy; Roman (Philadelphia, PA), Kilbanov; Alexander (Boston, MA)
Assignee: Collegium Pharmaceutical, Inc. (Canton, MA)
Application Number:12/823,628
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,449,909
Patent Claim Types:
see list of patent claims
Composition; Dosage form;

Drugs Protected by US Patent 8,449,909

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 8,449,909

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
9,248,195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs ➤ Sign Up
8,557,291 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
9,044,398 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:

Argus Health
Fuji
Deloitte
QuintilesIMS
Julphar
UBS
Mallinckrodt
Cerilliant
Medtronic

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