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Details for Patent: 8,394,405

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Patent 8,394,405 protects ORACEA and is included in one NDA. There has been one Paragraph IV challenge on Oracea. There are four tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has twelve patent family members in seven countries.

Summary for Patent: 8,394,405

Title:Once daily formulations of tetracyclines
Abstract: Disclosed are once-daily formulations containing tetracyclines, especially doxycycline. Such formulations are useful, for instance, for the treatment of collagenase destructive enzyme-dependent diseases, such as periodontal disease and acne, and acute and chronic inflammatory disease states, such as rosacea and arthritis.
Inventor(s): Chang; Rong-Kun (Rockville, MD), Raoufinia; Arash (Springfield, VA), Shah; Niraj (Owings Mills, MD)
Assignee: Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:12/926,932
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form; Use; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYes8,394,405► subscribeY TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
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Non-Orange Book Patents for Patent: 8,394,405

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
8,709,478Once daily formulations of tetracyclines► subscribe
7,749,532Once daily formulations of tetracyclines► subscribe
8,206,740Once daily formulations of tetracyclines► 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: 8,394,405

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada2521885► subscribe
Canada2803922► subscribe
Canada2894736► 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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