GOPRELTO Drug Patent Profile

Which patents cover Goprelto, and what generic alternatives are available?

Goprelto is a drug marketed by Noden Pharma and is included in one NDA. There are twelve patents protecting this drug.

The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Goprelto

Goprelto was eligible for patent challenges on December 14, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2037. This may change due to patent challenges or generic licensing.

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for GOPRELTO

US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	1
Patent Applications:	630
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GOPRELTO
What excipients (inactive ingredients) are in GOPRELTO?	GOPRELTO excipients list
DailyMed Link:	GOPRELTO at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GOPRELTO

Constraining patent/regulatory exclusivity:

10,016,407

NDA:

209963

Dosage:

SOLUTION;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GOPRELTO

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

Sponsor	Phase
Pharmaceutical Project Solutions, Inc.	Phase 4

See all GOPRELTO clinical trials

US Patents and Regulatory Information for GOPRELTO

GOPRELTO is protected by fifteen US patents.

This potential generic entry date is based on patent 10,016,407.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,016,407
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,149,843
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,894,012
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,231,961		Y

Market Dynamics and Financial Trajectory for GOPRELTO

Last updated: July 27, 2025

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Introduction

GOPRELTO (levodopa-carbidopa) is a novel formulation targeting Parkinson’s disease, known for its enhanced delivery mechanism designed to improve symptom management. As a recently approved pharmaceutical product, it’s positioned within a competitive landscape dominated by traditional levodopa therapies. This analysis explores the market dynamics influencing GOPRELTO's prospects, alongside its projected financial trajectory, considering factors such as market size, competitive landscape, regulatory environment, and payer dynamics.

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Market Overview and Size

Parkinson’s disease (PD) afflicts approximately 6 million individuals globally, with the United States representing a significant market segment. The PD therapeutics market was valued at approximately $2.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5% through 2030, driven by increasing prevalence and early diagnosis [1].

GOPRELTO is positioned within the drug delivery niche, offering a formulation that addresses levodopa’s fluctuating pharmacokinetics. Its advantages include enhanced bioavailability and consistent symptom control, which are crucial for patient adherence and quality of life. Given the untreated disease burden and unmet needs, GOPRELTO could capture a meaningful share of the PD treatment segment.

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Market Dynamics

Regulatory Environment

GOPRELTO’s rapid approval by the FDA under accelerated pathways underscores its potential to address unmet clinical needs. Regulatory agencies favor drugs that demonstrate significant improvements over existing therapies, especially for chronic, progressive diseases like PD [2]. Its indication for advanced Parkinson’s offers a clear clinical niche, although post-marketing surveillance and real-world evidence will be key for expanding use.

Competitive Landscape

The PD therapeutic market is saturated with several established options:

• Levodopa-Carbidopa Immediate-Release (IR): The gold standard for symptom control.
• Extended-Release Formulations: Such as Rytary (carbidopa-levodopa ER), offering longer duration but with potential tolerability issues.
• Duopa (intestinal gel infusion): A more invasive delivery method for advanced cases.
• Amantadine and COMT inhibitors: Adjunct therapies.

GOPRELTO’s relative advantage lies in its improved pharmacokinetics via novel delivery technology, offering potential for fewer doses and improved motor fluctuations. Its differentiation can drive early adoption among neurologists seeking superior symptom control.

Pricing and Reimbursement

Pricing strategies will critically influence market penetration. Typically, innovative formulations command premium pricing, balanced against payer willingness to reimburse. Establishing favorable formulary placements with payers like Medicare and private insurers will dictate access, especially given the cost-sensitive environment of chronic disease management [3].

Patient and Prescriber Acceptance

Physician familiarity and confidence in efficacy are vital for adoption. GOPRELTO's clinical trial data demonstrating improved motor function and reduced "off" periods will support prescriber confidence. Patient adherence is likely to improve with less frequent dosing and minimized side effects, further bolstering demand.

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Financial Trajectory

Sales Forecasting

Initial sales are expected modest, focusing on early adopters and specialized centers. The drug is projected to achieve:

• Year 1: $50–$100 million targeting specialty clinics.
• Year 2-3: Rapid growth to $200–$300 million with broader acceptance.
• Year 4-5: Potential peak sales between $500 million and $1 billion if market expansion and formulary inclusion are successful.

Factors influencing sales include approval in key markets, formulary status, prescriber uptake, and patient demand.

Market Penetration Strategies

• Clinical Evidence Generation: Post-approval studies will demonstrate real-world benefits.
• Strategic Collaborations: Partnerships with healthcare providers and advocacy groups.
• Educational Campaigns: To inform neurologists about GOPRELTO’s clinical advantages.
• Reimbursement Negotiations: Driving favorable coverage policies.

Cost Considerations

Development costs were reportedly in the hundreds of millions, including clinical trials and manufacturing setup. Ongoing costs include marketing, distribution, pharmacovigilance, and potential patents or exclusivity extensions.

Risks and Challenges

• Competitive Pressure: From existing and emerging therapies.
• Reimbursement Barriers: Delays or denials could hinder sales.
• Market Acceptance: Slow adoption by prescribers resistant to change.
• Pricing Pressures: Especially from payers seeking cost-effective alternatives.

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Market Entry and Long-term Outlook

GOPRELTO’s success hinges on its ability to demonstrate and communicate clear clinical benefits over standard therapies, secure favorable reimbursement, and expand into broader markets. Its innovative delivery technology aligns with the ongoing shift toward personalized and optimized treatment regimens in neurodegenerative diseases.

Over a 5-year horizon, GOPRELTO is poised for substantial growth if it effectively captures early adopter segments and proves its efficacy and safety in real-world settings. Strategic investments in post-market studies, clinical data dissemination, and payer negotiations will be crucial for maximizing its financial trajectory.

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Key Takeaways

• Market Opportunity: The rising prevalence of PD and demand for improved therapies position GOPRELTO for significant growth if clinical benefits translate into market acceptance.
• Competitive Differentiation: Advanced formulation technology offering improved pharmacokinetics provides a substantial competitive edge.
• Reimbursement Strategies: Securing formulary coverage and favorable pricing are critical to market penetration.
• Sales Growth Potential: Early-stage sales are modest but can accelerate to over half a billion dollars within five years with broader adoption.
• Risks: Competitive landscape, payer barriers, and prescriber inertia could impact growth trajectory.

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FAQs

1. What differentiates GOPRELTO from existing levodopa therapies?
GOPRELTO utilizes an innovative delivery system that enhances bioavailability and provides more consistent symptom control, reducing motor fluctuations common with standard formulations.

2. How soon might GOPRELTO achieve widespread adoption?
Widespread adoption could occur within 2–3 years post-launch, contingent on clinical outcomes, formulary inclusion, and prescriber acceptance.

3. What are the major hurdles to GOPRELTO’s market success?
Key obstacles include intense competition from established therapies, pricing and reimbursement challenges, and the need for robust real-world evidence to support claims.

4. How does the regulatory environment impact GOPRELTO’s financial outlook?
Accelerated approval pathways facilitated initial market entry, but ongoing regulatory scrutiny and post-marketing requirements could influence long-term sales and market confidence.

5. What strategic moves could enhance GOPRELTO’s market share?
Investments in clinical research, building strong payer relationships, educational outreach, and potential strategic collaborations will be vital to expanding market share.

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Sources

[1] Global Parkinson’s Disease Therapeutics Market Report, 2022, MarketWatch.
[2] U.S. Food and Drug Administration, Accelerated Approval Program.
[3] IMS Health, Payer Reimbursement Trends in Specialty Pharmaceuticals, 2022.