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Generated: May 30, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,309,060

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Which drugs does patent 8,309,060 protect, and when does it expire?


Patent 8,309,060 protects HYSINGLA, NUCYNTA ER, OPANA ER, and OXYCONTIN, and is included in four NDAs. There have been zero Paragraph IV challenges on Nucynta ER, Opana ER, and .

This patent has one hundred and twenty-seven patent family members in twenty-nine countries.

Summary for Patent: 8,309,060

Title:Abuse-proofed dosage form
Abstract: An abuse-proofed, thermoformed dosage form containing, in addition to one or more active ingredients with abuse potential optionally together with physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N and to a process for the production thereof.
Inventor(s): Bartholomaus; Johannes (Aachen, DE), Kugelmann; Heinrich (Aachen, DE), Arkenau-Mari ; Elisabeth (Koln, DE)
Assignee: Grunenthal GmbH (Aachen, DE)
Application Number:13/346,257
Patent Claim Types:
see list of patent claims
Dosage form; Compound; Formulation; Process; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-001Nov 20, 2014RXYesYes8,309,060► SubscribeY MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-002Nov 20, 2014RXYesNo8,309,060► SubscribeY MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-003Nov 20, 2014RXYesNo8,309,060► SubscribeY MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-004Nov 20, 2014RXYesNo8,309,060► SubscribeY MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-005Nov 20, 2014RXYesNo8,309,060► SubscribeY MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
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Foreign Priority and PCT Information for Patent: 8,309,060

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany103 36 400Aug 06, 2003

Non-Orange Book Patents for Patent: 8,309,060

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
8,114,384Process for the production of an abuse-proofed solid dosage form► Subscribe
8,075,872Abuse-proofed dosage form► Subscribe
8,420,056Abuse-proofed dosage form► Subscribe
8,192,722Abuse-proof dosage form► Subscribe
8,114,383Abuse-proofed dosage form► 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: 8,309,060

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina045352► Subscribe
Argentina045353► Subscribe
Argentina046994► Subscribe
Argentina049083► Subscribe
Argentina049839► 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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