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SKELAXIN Drug Profile

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Skelaxin is a drug marketed by King Pharms and is included in one NDA. It is available from twenty suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in SKELAXIN is metaxalone. There are nineteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for Tradename: SKELAXIN

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list20
Drug Prices: :see details

Pharmacology for Tradename: SKELAXIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms
SKELAXIN
metaxalone
TABLET;ORAL013217-001Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
King Pharms
SKELAXIN
metaxalone
TABLET;ORAL013217-003Aug 30, 2002RXYes7,122,566► subscribe ► subscribe
King Pharms
SKELAXIN
metaxalone
TABLET;ORAL013217-003Aug 30, 2002RXYes7,714,006► subscribe ► subscribe
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Paragraph IV activity for: SKELAXIN

Drugname Dosage Strength RLD Submissiondate
metaxaloneTablets800 mgSkelaxin11/4/2004

Non-Orange Book Patents for Tradename: SKELAXIN

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
7,378,434Metaxalone products, method of manufacture, and method of use► subscribe
6,683,102 Methods of using metaxalone in the treatment of musculoskeletal conditions► subscribe
6,407,128 Method for increasing the bioavailability of metaxalone► 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 Tradename: SKELAXIN

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007094825► subscribe
Canada2626027► 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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