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Last Updated: April 25, 2024

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RYTARY Drug Patent 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 eight patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-five patent family members in twelve countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Rytary

A generic version of RYTARY was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.

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Drug patent expirations by year for RYTARY
Drug Prices for RYTARY

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Drug Sales Revenue Trends for RYTARY

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Recent Clinical Trials for RYTARY

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 2
Northwestern UniversityPhase 2
Northwestern Medical GroupPhase 2

See all RYTARY clinical trials

Pharmacology for RYTARY
Anatomical Therapeutic Chemical (ATC) Classes for RYTARY
Paragraph IV (Patent) Challenges for RYTARY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RYTARY Extended-release Capsules carbidopa; levodopa 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg 203312 1 2015-06-24
RYTARY Extended-release Capsules carbidopa; levodopa 61.25 mg/245 mg 203312 1 2015-06-10

US Patents and Regulatory Information for RYTARY

RYTARY is protected by fifteen US patents.

Patents protecting RYTARY

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE

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

Expired US Patents for RYTARY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for RYTARY

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amneal Pharma Europe Ltd Numient levodopa, carbidopa EMEA/H/C/002611
Symptomatic treatment of adult patients with Parkinson’s disease
Withdrawn no no no 2015-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RYTARY

When does loss-of-exclusivity occur for RYTARY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08343787
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 11014
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1910113
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 34963
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6756
Estimated Expiration: ⤷  Try a Trial

Patent: 8520
Estimated Expiration: ⤷  Try a Trial

Patent: 3053
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 83725
Estimated Expiration: ⤷  Try a Trial

Patent: 33373
Estimated Expiration: ⤷  Try a Trial

Patent: 28205
Estimated Expiration: ⤷  Try a Trial

Patent: 11507956
Estimated Expiration: ⤷  Try a Trial

Patent: 15187178
Estimated Expiration: ⤷  Try a Trial

Patent: 17014295
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10007207
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 6870
Estimated Expiration: ⤷  Try a Trial

Patent: 2302
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1005309
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1451564
Estimated Expiration: ⤷  Try a Trial

Patent: 1569604
Estimated Expiration: ⤷  Try a Trial

Patent: 1752080
Estimated Expiration: ⤷  Try a Trial

Patent: 100099731
Estimated Expiration: ⤷  Try a Trial

Patent: 130113533
Estimated Expiration: ⤷  Try a Trial

Patent: 150133854
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 04348
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RYTARY around the world.

Country Patent Number Title Estimated Expiration
New Zealand 586870 Controlled release formulations of levodopa, carbidopa andd a caboxylic acid ⤷  Try a Trial
Canada 2711014 FORMULATIONS À LIBERATION CONTRÔLEE DE LEVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007016679 ⤷  Try a Trial
Japan 2005528430 ⤷  Try a Trial
South Korea 101451564 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.