RYTARY Drug Patent Profile

When do Rytary patents expire, and what generic alternatives are available?

Rytary is a drug marketed by Impax 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-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 DR REDDYS LABS SA on August 28^th, 1992.

Summary for RYTARY

International Patents:	25
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	2
Drug Prices:	Drug price information for RYTARY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYTARY
What excipients (inactive ingredients) are in RYTARY?	RYTARY excipients list
DailyMed Link:	RYTARY at DailyMed

See drug prices for RYTARY

See drug sales revenues for RYTARY

Recent Clinical Trials for RYTARY

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

Sponsor	Phase
Amneal Pharmaceuticals, LLC	PHASE4
The Cleveland Clinic	PHASE4
National Institutes of Health (NIH)	Phase 2

See all RYTARY clinical trials

Pharmacology for RYTARY

Drug Class

Aromatic Amino Acid

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.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No			Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No			Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No			Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015		RX	Yes	No			Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y

Expired US Patents for RYTARY

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

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/002611Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19

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

Canada

China

European Patent Office

Israel

Japan

Mexico

New Zealand

South Africa

South Korea

Spain

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
South Africa	201005309	CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF
South Korea	101569604
Japan	2015187178	レボドパの放出制御製剤及びその使用 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF)
Israel	263053	תערובות שחרור מבוקרות של ושמושיהן levodopa (Controlled release formulation of levodopa and uses thereof)
Japan	5783725
Mexico	2010007207	FORMULACIONES DE LIBERACION CONTROLADA DE LEVODOPA Y USOS DE LAS MISMAS. (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF.)
China	101910113	Controlled release formulations of levodopa and uses thereof

Supplementary Protection Certificates for RYTARY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Market Dynamics and Financial Trajectory for RYTARY: A Comprehensive Analysis

Last updated: July 27, 2025

Introduction

RYTARY, branded as capsule formulation of carbidopa-levodopa, is a significant pharmaceutical innovation developed by Neurocrine Biosciences and marketed by KEVARY. Approved by the FDA in 2017, RYTARY addresses motor fluctuations in patients with Parkinson’s disease (PD), offering an extended-release alternative to immediate-release formulations. Its market penetration, driven by evolving treatment paradigms and increasing PD prevalence, underscores its importance within the neurological therapeutics landscape. This analysis explores the key market drivers, competitive landscape, regulatory factors, and revenue projections shaping RYTARY’s financial trajectory.

Market Dynamics

Growing Prevalence and Demographic Shifts

The global Parkinson’s disease market is expanding robustly, projected to reach approximately USD 8 billion by 2025 [1]. Factors fueling this growth include aging populations worldwide—particularly in North America, Europe, and Asia—and improved disease awareness. According to the Parkinson’s Foundation, approximately 1 million Americans live with PD, with prevalence expected to double by 2060 due to demographic shifts [2].

This demographic trend directly benefits RYTARY's sales potential, as the drug primarily targets motor fluctuations in moderate-to-advanced PD. Its ability to provide sustained symptom control aligns with clinical needs for improved quality of life in aging populations.

Treatment Paradigm Evolution

Traditionally, levodopa has been the cornerstone of PD management. However, concerns over motor fluctuations and "wearing-off" phenomena have spurred demand for extended-release formulations like RYTARY. The drug's capability to provide smoother dopamine delivery and reduce dosing frequency addresses unmet needs, supporting adoption among neurologists and movement disorder specialists.

Moreover, the rise in personalized medicine and combination therapies influences prescribing patterns. RYTARY’s unique pharmacokinetic profile positions it favorably, especially for patients reluctant to multiple daily doses of immediate-release formulations.

Competitive Landscape

RYTARY faces competition from alternative formulations of carbidopa-levodopa:

• Immediate-release formulations (e.g., Sinemet)
• Other extended-release products (e.g., Rytary rivals under development or marketed formulations like Duodopa)
• Non-levodopa therapies (e.g., dopamine agonists, MAO-B inhibitors)

Despite competition, RYTARY’s pharmacokinetic advantage—providing a more consistent dopamine plasma concentration—differentiates it. Its patent protection until the late 2020s affords market exclusivity, although biosimilars or generics may emerge subsequently, pressuring prices.

Regulatory Environment

Rigid regulatory pathways and increasing emphasis on real-world evidence influence market dynamics. The FDA’s approval in 2017 catalyzed adoption, but ongoing post-marketing surveillance and new indications could further expand RYTARY's market scope.

Moreover, payor dynamics play a crucial role. Reimbursement policies favor drugs with demonstrated clinical benefit and cost-effectiveness, incentivizing formulary inclusion. Real-world studies demonstrating RYTARY's superiority in reducing motor fluctuations may facilitate broader insurance coverage.

Financial Trajectory

Historical Revenue Performance

Since its market introduction, RYTARY has experienced gradual revenue growth. Neurocrine Biosciences reported approximately USD 150 million in global sales during 2022, a substantial portion attributable to RYTARY [3]. U.S. sales dominate, driven by higher PD prevalence and greater prescribing rates.

The launch of expanded labeling—such as inclusion for early PD and off-label use for other movement disorders—augments revenue streams. Additionally, the critical role of RYTARY in treatment algorithms secures a steady revenue base amid market competition.

Forecasting Future Revenue

Multiple factors influence future revenue projections:

• Market Penetration: Continued uptake as awareness and prescribing increase.
• Pipeline Developments: Introduction of new formulations or combination therapies could dilute or complement RYTARY’s sales.
• Patent and Exclusivity Lifecycle: Patent expiration around 2028 could permit biosimilar entry, exerting downward pressure on prices.
• Pricing Strategies: Value-based pricing and risk-sharing agreements could optimize revenue, especially as payor scrutiny intensifies.
• Market Expansion: Increasing global adoption, especially in emerging markets, can provide additional revenue streams, contingent upon regulatory approvals and local pricing dynamics.

Based on current data and industry trends, analysts project RYTARY's revenues could reach USD 250-300 million annually by 2025 in the U.S. alone, with global markets adding further growth potential.

Profitability and Investment Outlook

Healthy margins are expected, given Neurocrine’s focus on high-value neurological therapeutics. However, impending patent cliffs necessitate strategic pipeline investments to sustain growth. RYTARY’s success hinges on balancing promotional efforts, payer negotiations, and competitive responses.

Strategic Drivers and Risk Factors

Key drivers:

• Increasing PD prevalence
• Clinical evidence supporting extended-release benefits
• Rising awareness amongst healthcare providers
• Favorable reimbursement policies

Risks:

• Patent expiry and biosimilar pressures
• Competitive innovations (e.g., new delivery systems)
• Fluctuating healthcare regulations
• Market saturation in mature regions

Conclusion

RYTARY’s market and financial trajectory reflect a confluence of demographic trends, specific therapeutic advantages, and strategic positioning within the PD treatment landscape. While near-term growth appears promising with expanding indications and geographic reach, long-term sustainability depends on innovation, patent management, and navigating competitive and regulatory environments.

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Key Takeaways

• RYTARY enjoys a favorable market position driven by rising Parkinson’s disease prevalence and clinical demand for extended-release formulations.
• Its sustained-release profile offers distinct advantages over immediate-release options, bolstering adoption among specialists.
• U.S. sales dominate, but global expansion remains a key growth avenue.
• Revenue projections indicate potential for significant growth, contingent upon maintaining exclusivity and addressing biosimilar threats post-2028.
• Strategic investments in pipeline development and patent protection are critical for long-term financial stability.

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FAQs

1. When does RYTARY’s patent protections expire, and what are the implications?
Patent protection for RYTARY is expected to last until approximately 2028. Post-expiry, biosimilar or generic competitors may enter the market, potentially reducing pricing power and eroding revenue unless Neurocrine Biosciences initiates new innovations or expands indications.

2. How does RYTARY compare to traditional levodopa formulations in cost-effectiveness?
While RYTARY generally commands higher retail prices due to its extended-release formulation, its improved symptom control and reduced dosing frequency may offset costs through enhanced patient adherence and quality of life. Health economic evaluations suggest its cost-effectiveness hinges on clinical outcomes and hospitalization reduction.

3. Are there upcoming clinical trials that could expand RYTARY’s indications?
Current trials are exploring RYTARY’s utility in early PD, off-label uses, and in combination with novel agents. Positive trial outcomes could expand its label and market potential, boosting revenue prospects.

4. What strategic maneuvers could Neurocrine Biosciences pursue post-patent expiration?
The company may focus on pipeline diversification, developing next-generation formulations, entering new markets, and pursuing licensing agreements. Investment in biosimilar development or alliances for market share defense may also be strategic.

5. How has COVID-19 affected RYTARY’s market growth?
Disruptions to healthcare access and elective procedures temporarily slowed prescription rates. However, telemedicine adoption and increased emphasis on managing chronic neurological conditions have mitigated long-term impacts, with sales rebounding as healthcare services resumed normal operations.

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References

1. [1] MarketsandMarkets. Parkinson’s disease therapeutics market forecast (2021).
2. [2] Parkinson’s Foundation. Data & Statistics. Accessed 2023.
3. [3] Neurocrine Biosciences Annual Report (2022).