SINEMET CR Drug Patent Profile

Which patents cover Sinemet Cr, and what generic alternatives are available?

Sinemet Cr is a drug marketed by Organon Llc and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sinemet Cr

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

Summary for SINEMET CR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	86
DailyMed Link:	SINEMET CR at DailyMed

Recent Clinical Trials for SINEMET CR

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

Sponsor	Phase
Julien Bally	PHASE1
University of California, Los Angeles	Phase 1/Phase 2
Laboratorios Andromaco S.A.	Phase 1

See all SINEMET CR clinical trials

US Patents and Regulatory Information for SINEMET CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992		DISCN	Yes	No
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991		DISCN	Yes	No

Expired US Patents for SINEMET CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991

EU/EMA Drug Approvals for SINEMET CR

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Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19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 SINEMET CR

See the table below for patents covering SINEMET CR around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	413737
Singapore	52191
Austria	A490073
South Africa	7004123

Supplementary Protection Certificates for SINEMET CR

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 SINEMET CR

Last updated: February 8, 2026

Market Overview

SINEMET CR (carbidopa-levodopa extended-release) is an oral medication used primarily for Parkinson's disease management. The drug offers a slow-release formulation designed to stabilize plasma levels of levodopa, reducing the "wearing-off" phenomenon associated with immediate-release formulations.

Market Size and Growth

The global Parkinson's disease treatment market was valued at approximately $3.9 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.5% through 2028. The increasing prevalence of Parkinson's—estimated at around 1 million Americans and 10 million globally—drives demand for long-acting formulations like SINEMET CR.

Key Market Players and Competition

• Existing Formulation: Merck's (MSD) Sinemet CR is a dominant player, with market share concentrated in North America and Europe.
• Emerging Competition: Several generic manufacturers have entered the market following patent expirations. Companies like Sun Pharma and Teva are producing generic extended-release formulations.
• Pipeline Developments: Limited pipeline drugs are targeting Parkinson's with novel mechanisms, but SINEMET CR remains the standard of care for extended-release needs.

Regulatory Status and Market Access

• FDA approval for SINEMET CR is established, with generic versions also approved.
• Reimbursement levels vary across regions, with Medicare in the U.S. covering many prescriptions.

Financial Trajectory

Revenue Trends

• Historical Sales: In 2021, Merck reported global sales of SINEMET CR at approximately $400 million.
• Growth Drivers: Increased Parkinson's prevalence, aging demographics, and physician preference for extended-release formulations.
• Market Penetration: In the U.S., SINEMET CR accounts for an estimated 30% of carbidopa-levodopa prescriptions for Parkinson's.

Pricing and Margins

• Pricing: The list price for branded SINEMET CR in the U.S. stood at around $10 per tablet in 2022.
• Generics Impact: Generic versions retail at approximately $3-$5 per tablet, exerting pressure on margins.
• Profitability: Branded sales tend to yield higher margins; generics reduce overall profitability margins accordingly.

Forecasting Revenue

• Based on current market share and demographic trends, annual sales are expected to grow modestly, at a CAGR of approximately 3-5% over the next five years, assuming stable patent protection and no significant generics market penetration.

Key Risks

• Patent expiration or legal challenges could accelerate generic competition.
• New therapies, such as gene therapies or dopamine receptor modulators, could replace traditional formulations.
• Regulatory changes affecting reimbursement could influence sales.

Pricing Dynamics

• The introduction of biosimilars and generics in key markets is expected to pressure prices downward.
• Price erosion could reduce branded SINEMET CR revenues by 10-15% over five years.

Conclusion

SINEMET CR maintains a stable revenue base driven by the prevalence of Parkinson's disease and its clinical position. Market growth remains steady, but increasing competition and evolving treatment paradigms pose risks to long-term sales stability.

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Key Takeaways

• The global Parkinson's treatment market is expanding, bolstered by demographic shifts.
• SINEMET CR generated approximately $400 million in 2021, with modest growth prospects.
• Competition from generics is increasing, imposing pricing pressure.
• Revenue growth is projected at 3-5% annually, contingent on patent exclusivity and market dynamics.
• Emerging therapies could challenge the established role of SINEMET CR over the next decade.

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FAQs

1. How does SINEMET CR compare to immediate-release formulations?
SINEMET CR provides a sustained release of levodopa, reducing fluctuations and "wearing-off" effects, improving patient adherence and symptom management.

2. What is the patent status of SINEMET CR?
The original patent expired in the U.S. in 2008, leading to generic competition. Patent protections and exclusivity periods vary globally.

3. Are there any upcoming developments that could impact SINEMET CR sales?
Yes. New medications or gene therapies in late-stage development could alter the treatment landscape, potentially reducing reliance on traditional formulations.

4. How sensitive is the market to pricing changes?
Highly sensitive. The availability of generics at lower prices creates pricing pressures that can significantly impact revenues and margins.

5. What regions are the primary markets for SINEMET CR?
North America and Europe are primary, with significant sales also in parts of Asia and Latin America. Reimbursement policies and physician preferences influence regional performance.

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Citations

[1] Market Research Future, “Parkinson’s Disease Treatment Market,” 2022.
[2] IQVIA, “Global Parkinson’s Disease Drug Market Data,” 2021.
[3] Merck Annual Report, 2021.
[4] U.S. FDA, “Product Approval and Patent Information,” 2022.