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RYTARY Drug Profile

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Rytary is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-three patent family members in thirteen countries.

The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for Tradename: RYTARY

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list2
Patent Applications: see list24
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RYTARY at DailyMed

Pharmacology for Tradename: RYTARY

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-003Jan 7, 2015RXNo8,557,283► subscribeY ► subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-004Jan 7, 2015RXYes► subscribe► subscribe
Impax Labs Inc
RYTARY
carbidopa; levodopa
CAPSULE, EXTENDED RELEASE;ORAL203312-003Jan 7, 2015RXNo► subscribe► subscribe
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Paragraph IV activity for: RYTARY

Drugname Dosage Strength RLD Submissiondate
carbidopa and levodopaExtended-release Capsules23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mgRytary6/24/2015
carbidopa and levodopaExtended-release Capsules61.25 mg/245 mgRytary6/10/2015

Non-Orange Book Patents for Tradename: RYTARY

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
9,533,046Controlled release formulations of levodopa and uses thereof► 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: RYTARY

Country Document Number Estimated Expiration
Israel248520► subscribe
Mexico2010007207► subscribe
Japan2005528430► 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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