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Details for Patent: 8,410,077

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Patent 8,410,077 protects CARNEXIV, EVOMELA, and NOXAFIL, and is included in three NDAs. There have been three Paragraph IV challenges on Noxafil. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has eighteen patent family members in twelve countries.

Summary for Patent: 8,410,077

Title:Sulfoalkyl ether cyclodextrin compositions
Abstract: SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Inventor(s): Antle; Vincent (Olathe, KS)
Assignee: CyDex Pharmaceuticals, Inc. (La Jolla, CA)
Application Number:12/613,103
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use; Device; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Lundbeck Llc
CARNEXIV
carbamazepine
SOLUTION;IV (INFUSION)206030-001Oct 7, 2016RXYes8,410,077► subscribeY
Spectrum Pharms
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXNo8,410,077► subscribeY
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYes8,410,077► subscribeY
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Non-Orange Book Patents for Patent: 8,410,077

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
7,635,773Sulfoalkyl ether cyclodextrin compositions► subscribe
9,200,088Sulfoalkyl ether cyclodextrin compositions► 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: 8,410,077

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2009241858► subscribe
BrazilPI0905080► subscribe
Canada2702603► 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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