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Last Updated: September 27, 2022

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 nine patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-eight 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-six 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 MAYNE PHARMA on August 28th, 1992.

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Drug patent expirations by year for RYTARY
Drug Prices for RYTARY

See drug prices for RYTARY

Drug Sales Revenue Trends for RYTARY

See drug sales revenues for RYTARY

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 sixteen US patents.

Patents protecting RYTARY

Combination immediate release controlled release levodopa/carbidopa dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 203312-002 Jan 7, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 203312-001 Jan 7, 2015 See Plans and Pricing See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 See Plans and Pricing See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 See Plans and Pricing See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Canada

Patent: 11014
Estimated Expiration: See Plans and Pricing

China

Patent: 1910113
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 34963
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6756
Estimated Expiration: See Plans and Pricing

Patent: 8520
Estimated Expiration: See Plans and Pricing

Patent: 3053
Estimated Expiration: See Plans and Pricing

Japan

Patent: 83725
Estimated Expiration: See Plans and Pricing

Patent: 33373
Estimated Expiration: See Plans and Pricing

Patent: 28205
Estimated Expiration: See Plans and Pricing

Patent: 11507956
Estimated Expiration: See Plans and Pricing

Patent: 15187178
Estimated Expiration: See Plans and Pricing

Patent: 17014295
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10007207
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6870
Estimated Expiration: See Plans and Pricing

Patent: 2302
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1005309
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1451564
Estimated Expiration: See Plans and Pricing

Patent: 1569604
Estimated Expiration: See Plans and Pricing

Patent: 1752080
Estimated Expiration: See Plans and Pricing

Patent: 100099731
Estimated Expiration: See Plans and Pricing

Patent: 130113533
Estimated Expiration: See Plans and Pricing

Patent: 150133854
Estimated Expiration: See Plans and Pricing

Spain

Patent: 04348
Estimated Expiration: See Plans and Pricing

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
Canada 2711014 FORMULATIONS À LIBERATION CONTRÔLEE DE LEVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) See Plans and Pricing
European Patent Office 2234963 FORMULATIONS À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) See Plans and Pricing
Mexico 2010007207 FORMULACIONES DE LIBERACION CONTROLADA DE LEVODOPA Y USOS DE LAS MISMAS. (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF.) See Plans and Pricing
Spain 2804348 See Plans and Pricing
China 101910113 Controlled release formulations of levodopa and uses thereof See Plans and Pricing
South Korea 20150133854 레보도파 방출 제어형 제제 및 이의 용도 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Harvard Business School
Colorcon
Express Scripts

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.