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Details for Patent: 9,044,398

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Patent 9,044,398 protects XTAMPZA ER and is included in one NDA.

This patent has thirteen patent family members in five countries.

Summary for Patent: 9,044,398

Title:Abuse-deterrent pharmaceutical compositions of opiods 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 opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. 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 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), Klibanov; Alexander M. (Newton, MA), Swager; Timothy M. (Newton, MA), Buchwald; Stephen L. (Newton, MA), Lo; Whe Yong (Canton, MA), Fleming; Alison (Marshfield, MA), Rariy; Roman V. (Allston, MA)
Assignee: Collegium Pharmaceutical, Inc. (Canton, MA)
Application Number:13/551,455
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 71st percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Collegium Pharm Inc
XTAMPZA ER
oxycodone
CAPSULE, EXTENDED RELEASE;ORAL208090-001Apr 26, 2016RXNo9,044,398► subscribeY
Collegium Pharm Inc
XTAMPZA ER
oxycodone
CAPSULE, EXTENDED RELEASE;ORAL208090-002Apr 26, 2016RXNo9,044,398► subscribeY
Collegium Pharm Inc
XTAMPZA ER
oxycodone
CAPSULE, EXTENDED RELEASE;ORAL208090-003Apr 26, 2016RXNo9,044,398► subscribeY
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Non-Orange Book Patents for Patent: 9,044,398

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
9,248,195Abuse-deterrent pharmaceutical compositions of opioids and other drugs► subscribe
8,449,909Abuse-deterrent drug formulations► subscribe
7,399,488Abuse-deterrent pharmaceutical compositions of opiods and other drugs► 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: 9,044,398

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2003247876► subscribe
Canada2491572► subscribe
Canada2569958► 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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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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