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-five 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:	84
Patent Applications:	464
DailyMed Link:	SINEMET CR at DailyMed

Recent Clinical Trials for SINEMET CR

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

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
Laboratorios Andromaco S.A.	Phase 1
Northwestern Medical Group	Phase 2

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	4,900,755
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	4,832,957
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	4,832,957
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	3,830,827
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	4,900,755

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Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19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	2052691
Canada	919689	PROCESS FOR PREPARING SUBSTITUTED PHENYLALKANOIC ACIDS
Japan	H0667830
Austria	58473
Yugoslavia	185678

SINEMET CR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SINEMET CR

Introduction

SINEMET CR, a sustained-release formulation of carbidopa and levodopa, has been a significant player in the treatment of Parkinson’s disease, particularly for patients with motor fluctuations. Here, we delve into the market dynamics and financial trajectory of this medication.

Therapeutic Indication and Mechanism

SINEMET CR is designed to control the release of carbidopa and levodopa, providing a more stable and prolonged therapeutic effect compared to the standard formulation of Sinemet. This polymeric-based drug delivery system helps in managing the symptoms of Parkinson’s disease, such as tremor, slowness, and stiffness, more effectively over a longer period[3].

Market Presence and Revenue

Historically, SINEMET CR has generated substantial revenue in the neurology segment. From 2015 to 2021, the annual sales of SINEMET CR showed significant growth, with revenues increasing from $231 million in 2015 to $511 million in 2021. However, there was a decline in revenue to $458 million in 2022, followed by a slight increase to $468 million in 2023[2].

Revenue Growth and Decline

• The revenue growth was notable, with a 27% increase from 2015 to 2016 and a 21% increase from 2017 to 2018.
• Despite the overall positive trend, there was a 10% decline in revenue from 2021 to 2022, which could be attributed to various market and regulatory factors[2].

Discontinuation of Brand Name SINEMET CR

In 2019, Merck announced the discontinuation of the brand name SINEMET CR in the United States due to difficulties in maintaining a reliable and stable supply. This decision, though challenging for patients, has led to a shift towards generic alternatives and other medication options[5].

Impact on the Parkinson’s Disease Drugs Market

The discontinuation of brand name SINEMET CR has not significantly diminished the presence of carbidopa and levodopa formulations in the market. Generic alternatives continue to be available, and other medications have emerged to fill the gap.

Market Share

In 2023, the SINEMET CR segment, including its generic alternatives, still accounted for a noticeable share of the global Parkinson’s disease drugs market. This segment is projected to experience significant growth in the near future, driven by the ongoing demand for effective Parkinson’s disease treatments[4].

Cost-Effectiveness and Patient Outcomes

Studies have shown that although SINEMET CR is more costly than the standard Sinemet, it may be more cost-effective for patients with motor fluctuations. Patients on SINEMET CR experienced improved disease control, with an increase in "on" time without chorea by 2.2 hours and a reduction in the total cost per hour "on" without chorea[1].

Pharmaceutical Market Dynamics

The Parkinson’s disease drugs market is witnessing significant growth, driven by increasing prevalence and the introduction of new medications and formulations. Key companies like Merck, GSK, and others are focusing on strengthening their product portfolios and expanding their business globally[4].

Competitive Landscape

The discontinuation of brand name SINEMET CR has opened up opportunities for other pharmaceutical companies to introduce their own versions of carbidopa and levodopa formulations. This competition is expected to drive innovation and potentially lower costs for patients.

Patient Impact and Clinical Benefits

For patients, SINEMET CR offered the benefit of fewer doses per day and better symptom control, especially overnight. The transition to generic alternatives or other medications will require careful management by healthcare providers to ensure minimal disruption to patient care[5].

Future Outlook

Despite the discontinuation of the brand name, the demand for carbidopa and levodopa formulations remains strong. The market is expected to continue growing, driven by the need for effective treatments for Parkinson’s disease. New formulations and medications are likely to emerge, offering patients a range of options to manage their symptoms effectively.

Key Takeaways

• Revenue Trends: SINEMET CR has shown significant revenue growth over the years but faced a decline in recent years.
• Discontinuation: The brand name SINEMET CR is no longer available in the U.S., but generic alternatives continue to be an option.
• Cost-Effectiveness: Despite higher costs, SINEMET CR may be more cost-effective for patients with motor fluctuations.
• Market Dynamics: The Parkinson’s disease drugs market is growing, with key companies focusing on expanding their product portfolios.
• Patient Impact: The transition to generic or other medications requires careful management to ensure minimal disruption to patient care.

FAQs

What is the main therapeutic indication of SINEMET CR?

SINEMET CR is primarily used for the treatment of Parkinson’s disease, particularly for managing motor fluctuations.

Why was the brand name SINEMET CR discontinued?

The brand name SINEMET CR was discontinued due to difficulties in maintaining a reliable and stable supply, as announced by Merck in 2019.

Are there generic alternatives available for SINEMET CR?

Yes, generic alternatives to SINEMET CR are available and continue to be an option for patients.

How does SINEMET CR compare to the standard Sinemet in terms of cost-effectiveness?

Although SINEMET CR is more costly, it may be more cost-effective for patients with motor fluctuations due to improved disease control and reduced need for adjunctive medications.

What is the future outlook for the Parkinson’s disease drugs market?

The market is expected to continue growing, driven by the need for effective treatments for Parkinson’s disease, with new formulations and medications likely to emerge.

Sources

1. Pharmacoeconomic analysis of using Sinemet CR over standard Sinemet in patients with Parkinson's disease - PubMed
2. SINEMET CR | Annual Sales Report - PharmaCompass
3. SINEMET CR - accessdata.fda.gov
4. Parkinson Disease Drugs Market Report 2024 (Global Edition) - Cognitive Market Research
5. Sinemet CR Discontinued but Other Options Available - The Michael J. Fox Foundation