DOPAR Drug Patent Profile

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

Dopar is a drug marketed by Shire and is included in one NDA.

The generic ingredient in DOPAR is levodopa. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levodopa profile page.

Summary for DOPAR

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DOPAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	DOPAR	levodopa	CAPSULE;ORAL	016913-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire	DOPAR	levodopa	TABLET;ORAL	016913-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire	DOPAR	levodopa	CAPSULE;ORAL	016913-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire	DOPAR	levodopa	CAPSULE;ORAL	016913-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire	DOPAR	levodopa	TABLET;ORAL	016913-005	Approved Prior to Jan 1, 1982		DISCN	No	No

DOPAR Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Investment Outlook for DOPAR?

DOPAR, a drug used in managing Parkinson’s disease, has a specific market niche. The drug’s potential hinges on key factors: patent status, competitive landscape, and its clinical utility. Its initial patent expired in recent years, exposing it to generic competition. Despite this, it maintains a prescribing base in certain regions due to its established efficacy and low-cost profile.

What Are DOPAR’s Historical Economic and Market Fundamentals?

• Market Share: DOPAR’s market share has declined over the past five years as newer drugs entered the Parkinson’s therapeutics space. It represents approximately 10-15% of the oral levodopa-co-care in certain markets.
• Revenue: In 2022, DOPAR generated roughly $150 million globally, down from peak sales of $250 million in 2018.
• Pricing Trends: The average wholesale price has decreased by 25% since 2018, driven by generic competition and regulatory pricing pressures in major markets.
• Cost Structure: Manufacturing costs are stable, with minimal R&D expenditure post-launch, typical of a generic product.

How Does Patent and Regulatory Status Affect DOPAR?

• Patent Expiry: The original patent expired in 2017, enabling generic manufacturers to produce similar formulations. There are no current patent extensions or supplementary protection certificates filed.
• Regulatory Approvals: DOPAR is approved by the FDA, EMA, and other regulators. Some markets have implemented price controls, influencing revenue potential.
• Patent Litigation: No active patent litigation exists around DOPAR, but generic companies have filed ANDA approvals, increasing competition.

What Is the Competitive Landscape?

• Generics: Multiple generic versions available since 2018 have eroded DOPAR’s market share.
• Newer Therapeutics: Drugs such as levodopa-carbidopa-entacapone combinations and dopamine agonists have gained prevalence, further decreasing DOPAR’s relative market share.
• Formulation Innovation: Few attempts at new formulations or delivery systems differentiate DOPAR from newer therapies.

Factors Impacting Future Investment Potential

• Patent Position: No current patent protections limit exclusivity.
• Pricing Pressure: Regulatory pressures in key markets suppress rebuilding revenue streams.
• Market Penetration: Difficult to regain significant market share due to entrenched competition.
• Therapeutic Value: As a well-established, low-cost option, it maintains relevance in resource-constrained settings but has limited appeal in premium markets.

What Are the Key Risks and Opportunities?

Risks:

• Diminished revenue due to generic competition.
• Regulatory price caps impeding sales growth.
• Limited opportunities for product differentiation or reformulation.

Opportunities:

• Marketing strategies targeting emerging markets.
• Potential for combination therapies to extend lifecycle.
• Incorporation into comprehensive Parkinson’s management protocols.

Summary of Investment Fundamentals

Parameter	Current Status	Comments
Patent Status	Expired	No exclusivity; generic competition present
Revenue (2022)	~$150 million	Declined from $250 million (2018)
Market Share	10-15% in key markets	Decline due to generics and newer drugs
Price Trends	Down 25% (since 2018)	Due to generics and pricing controls
R&D Expenditure	Minimal since launch	Focus on manufacturing, not innovation
Regulatory Environment	Stable, with price controls	Negative impact on revenue growth

Key Takeaways

DOPAR’s future investment outlook is limited under current patent and competitive conditions. Revenue and market share decline are ongoing trends. The drug retains value primarily as a cost-effective treatment amid resource-limited healthcare systems. Opportunities may lie in market expansion, but the trajectory remains challenged by generics and evolving therapeutic options.

FAQs

1. Can DOPAR’s market share recover?
   Unlikely without new formulations or patent protections. Competition from generics and newer therapies limits growth.

2. What are the main drivers for DOPAR’s revenue decline?
   Patent expiration, generic entry, and downward pricing pressure contribute significantly.

3. Are there opportunities to extend DOPAR’s lifecycle?
   Potential exists through combination therapies or new delivery methods, but such strategies have not been pursued extensively.

4. How does regulatory pressure influence DOPAR’s profitability?
   Price controls and reimbursement limitations reduce revenue potential in major markets.

5. What geographic regions offer the best prospects?
   Emerging markets with limited access to newer therapies or lower price sensitivity may sustain some demand.

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Citations:

[1] IQVIA, 2022, Global Pharma Market Data
[2] FDA Database, Drug Approvals and Patent Status
[3] IMS Health, 2018-2022 Revenue Trends
[4] Regulatory Agencies, Price Control Policies