SINEMET Drug Patent Profile

Which patents cover Sinemet, and when can generic versions of Sinemet launch?

Sinemet is a drug marketed by Organon and Organon Llc and is included in two NDAs.

The generic ingredient in SINEMET 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

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

Summary for SINEMET

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	84
Drug Prices:	Drug price information for SINEMET
What excipients (inactive ingredients) are in SINEMET?	SINEMET excipients list
DailyMed Link:	SINEMET at DailyMed

See drug prices for SINEMET

Recent Clinical Trials for SINEMET

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 clinical trials

Pharmacology for SINEMET

Drug Class

Aromatic Amino Acid

US Patents and Regulatory Information for SINEMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992		DISCN	Yes	No
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for SINEMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	3,830,827
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982	3,781,415
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	RE29892
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	3,781,415

EU/EMA Drug Approvals for SINEMET

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

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

Country	Patent Number	Title	Estimated Expiration
Belgium	752108
Yugoslavia	35111
Yugoslavia	185478
Japan	S5425012

SINEMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sinemet

Introduction to Sinemet

Sinemet, a combination of levodopa and carbidopa, is a cornerstone in the treatment of Parkinson's disease. It is widely used to manage the symptoms of this neurodegenerative disorder, particularly in the early and advanced stages.

Market Size and Growth

The global Parkinson's disease drug market, which includes Sinemet, is projected to experience significant growth over the coming years. By 2029, the global value of the Parkinson's disease market is estimated to reach $5.2 billion, representing a 43% increase from 2019 and a compound annual growth rate (CAGR) of 4%[1].

Segment Contribution

In the global Parkinson's disease drugs market, the Sinemet-CR segment, which is the extended-release formulation of Sinemet, accounts for a noticeable share. This segment is expected to experience significant growth in the near future, driven by its efficacy in managing motor fluctuations in patients with Parkinson's disease[4].

Demographic Segmentation

The market for Parkinson's disease drugs, including Sinemet, is segmented based on age groups: under 40 years old, 40-65 years old, and above 65 years old. The segment above 65 years old is particularly significant due to the higher prevalence of Parkinson's disease in this age group. However, the under 40 years old segment is also expected to expand at a significant CAGR, indicating a growing need for effective treatments across all age groups[2].

Geographic Distribution

Geographically, the market for Parkinson's disease drugs is divided into regions such as North America, Europe, Asia-Pacific, and others. North America and the Asia-Pacific region are expected to drive significant growth due to the launch of new drug delivery systems and a larger number of patients seeking treatment for Parkinson's disease[1][2].

Novel Drug Delivery Systems

The launch of novel drug delivery systems, such as inhaled and sublingual film formulations, as well as continuous subcutaneous infusions, is expected to drive value sales in the Parkinson's disease market. These new formulations will significantly increase the value share of inhaled and pre-filled syringe forms, with inhalation forms projected to increase their value share from 0% to 7% and pre-filled syringes from 1% to 16% globally between 2019 and 2029[1].

Cost-Effectiveness of Sinemet CR

Sinemet CR, the extended-release formulation, has been shown to be more cost-effective in patients with motor fluctuations despite being more costly than the standard Sinemet. A pharmacoeconomic analysis revealed that patients experienced improved disease control with Sinemet CR, resulting in an increase in "on" time without chorea and a reduction in the cost per hour of effective treatment[3].

Competitive Landscape

The market for Parkinson's disease drugs, including Sinemet, is highly competitive with key companies such as Merck, GSK, Novartis, and others focusing on strengthening their product portfolios. These companies are investing in research and development to introduce new and innovative treatments, which is expected to further drive market growth[2][4].

Funding and Research Initiatives

Organizations like the Michael J. Fox Foundation are playing a crucial role in funding research and clinical trials for new treatments, including those for Parkinson's disease. Such initiatives have significantly altered the trajectory of progress toward new treatments and have the potential to bring forward innovative therapies that address urgent symptoms like levodopa-induced dyskinesia (LID)[5].

Patent Expiries and Revenue Impact

The Parkinson's disease drug market will experience both positive and negative impacts due to patent expiries. While new launches are expected to add approximately $14.8 billion in revenue between 2020 and 2029, several leading therapies, including some related to Sinemet, will lose patent protection, resulting in an estimated revenue loss of $4.7 billion. However, the net impact is expected to be positive in most regions, except Japan, where the number of loss of protection events is higher[1].

Future Outlook

The future outlook for Sinemet and the broader Parkinson's disease drug market is promising. With the introduction of novel drug delivery systems, ongoing research initiatives, and a growing patient base, the market is poised for significant growth. The extended-release formulation, Sinemet CR, is expected to continue playing a vital role in managing Parkinson's disease symptoms effectively and cost-efficiently.

Key Takeaways

• The global Parkinson's disease drug market, including Sinemet, is projected to reach $5.2 billion by 2029.
• Sinemet CR is expected to experience significant growth due to its efficacy in managing motor fluctuations.
• Novel drug delivery systems will drive value sales and increase the market share of inhaled and pre-filled syringe forms.
• Cost-effectiveness studies show that Sinemet CR provides improved disease control and reduced costs per hour of effective treatment.
• Key companies are investing in research and development to introduce new treatments.
• Funding initiatives by organizations like the Michael J. Fox Foundation are crucial for advancing new therapies.

FAQs

Q: What is the projected market size for the Parkinson's disease drug market by 2029? A: The global value of the Parkinson's disease market is estimated to reach $5.2 billion by 2029[1].

Q: How does Sinemet CR compare to standard Sinemet in terms of cost-effectiveness? A: Sinemet CR is more cost-effective despite being more costly, as it provides improved disease control and increases "on" time without chorea, reducing the cost per hour of effective treatment[3].

Q: What role do novel drug delivery systems play in the Parkinson's disease market? A: Novel drug delivery systems, such as inhaled and sublingual film formulations, will drive value sales and significantly increase the market share of inhaled and pre-filled syringe forms[1].

Q: Which regions are expected to drive significant growth in the Parkinson's disease drug market? A: North America and the Asia-Pacific region are expected to drive significant growth due to the launch of new drug delivery systems and a larger number of patients seeking treatment[1][2].

Q: How do patent expiries impact the revenue of Parkinson's disease drugs? A: While new launches will add revenue, patent expiries will result in revenue losses, but the net impact is expected to be positive in most regions except Japan[1].

Sources

1. IQVIA, "Novel Drug Delivery Systems Drive Value Growth in the Parkinson's Disease Market," April 2020.
2. Market Research Intellect, "Global Parkinson's Disease Drug Market Size | Share | Scope | Trend," December 2024.
3. PubMed, "Pharmacoeconomic analysis of using Sinemet CR over standard Sinemet in patients with Parkinson's disease," 1998.
4. Cognitive Market Research, "Parkinson Disease Drugs Market Report 2024 (Global Edition)," December 2021.
5. The Michael J. Fox Foundation, "Early Trial Results Give Hope for a New Potential Dyskinesia Treatment for People with Parkinson’s," March 2023.