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Last Updated: October 23, 2020

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RYTARY Drug Profile

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When do Rytary patents expire, and when can generic versions of Rytary launch?

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

This drug has thirty-seven patent family members in fourteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Rytary

Annual sales in 2018 were $79mm indicating the motivation for generic entry (peak sales were $108mm in 2015).

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for RYTARY
Tradename Dosage Ingredient NDA Submissiondate
RYTARY CAPSULE, EXTENDED RELEASE;ORAL carbidopa; levodopa 203312 2015-06-24
RYTARY CAPSULE, EXTENDED RELEASE;ORAL carbidopa; levodopa 203312 2015-06-10

US Patents and Regulatory Information for RYTARY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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