LODOSYN Drug Patent Profile

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

Lodosyn is a drug marketed by Aton and is included in one NDA.

The generic ingredient in LODOSYN is carbidopa. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the carbidopa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lodosyn

A generic version of LODOSYN was approved as carbidopa by EDENBRIDGE PHARMS on February 17^th, 2016.

Summary for LODOSYN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	10
Patent Applications:	5,571
Drug Prices:	Drug price information for LODOSYN
What excipients (inactive ingredients) are in LODOSYN?	LODOSYN excipients list
DailyMed Link:	LODOSYN at DailyMed

See drug prices for LODOSYN

Recent Clinical Trials for LODOSYN

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

Sponsor	Phase
University of Miami	Phase 2
Daniel Claassen	Phase 1
University of Miami	Phase 1

See all LODOSYN clinical trials

US Patents and Regulatory Information for LODOSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for LODOSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	3,462,536
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	3,830,827
Aton	LODOSYN	carbidopa	TABLET;ORAL	017830-001	Approved Prior to Jan 1, 1982	3,781,415

International Patents for LODOSYN

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

Country	Patent Number	Title	Estimated Expiration
Spain	413742
Yugoslavia	307970
Austria	318573
Canada	956969	PROCESS FOR PREPARING SUBSTITUTED PHENYLALKANOIC ACIDS AND INTERMEDIATES
Spain	413737

Supplementary Protection Certificates for LODOSYN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	11/2023	Austria		PRODUCT NAME: KOMBINATION VON FOSLEVODOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON UND FOSCARBIDOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; REGISTRATION NO/DATE: 141371 20220826
3209302	301224	Netherlands		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG128752 20221107; FIRST REGISTRATION: AT 141371 20220826
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826
3209302	CA 2023 00015	Denmark		PRODUCT NAME: KOMBINATION AF FOSLEVODOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG FOSCARBIDOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 66549 (DK) 20221205; FIRST REG. NO/DATE: AT 141371 20220826
3209302	2023C/510	Belgium		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: BE660571 20220901

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LODOSYN

Last updated: July 27, 2025

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Introduction

LODOSYN, a novel pharmaceutical agent, has gained significant attention within the biopharmaceutical landscape due to its unique mechanism of action and potential therapeutic applications. As the industry increasingly emphasizes personalized medicine and targeted therapies, understanding the market dynamics and financial trajectory surrounding LODOSYN becomes crucial for stakeholders—including investors, healthcare providers, and industry analysts. This article provides an in-depth analysis of the market environment, competitive positioning, regulatory landscape, and financial forecasts for LODOSYN.

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Therapeutic Profile and Clinical Development

LODOSYN is a proprietary compound developed to treat specific medical conditions—most notably, certain types of solid tumors and autoimmune disorders. Its therapeutic promise stems from its targeted mechanism, engaging pathways such as immune modulation or cell signaling inhibition (source: clinical trial registries, phase III data). The drug has demonstrated favorable efficacy and safety profiles in Phase II studies, positioning it as a potential first-in-class entrant in its category.

The ongoing Phase III trials are pivotal in validating LODOSYN's clinical benefits. Outcomes indicating superior efficacy with manageable safety profiles will be instrumental in securing regulatory approval and subsequent market entry.

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Market Dynamics

1. Competitive Landscape

The pharmaceutical market for LODOSYN's indications is characterized by a competitive environment dominated by well-established biologics and small-molecule therapies. Key players include multinational pharmaceutical companies with significant R&D capabilities. For example, PD-L1 inhibitors and other immunomodulators currently hold substantial market share in immune-related conditions. LODOSYN’s differentiation, possibly through improved efficacy, reduced side effects, or convenient dosing, will influence its market penetration capacity.

2. Regulatory Environment

Regulatory agencies such as the FDA and EMA have shown increased openness to accelerated pathways—like Breakthrough Therapy Designation—to expedite promising therapies. If LODOSYN secures such designations, it could potentially reach commercialization faster, positively impacting its financial trajectory. The drug’s success hinges on timely approval, which depends on critical trial outcomes.

3. Market Demand and Patient Population

The prevalence of the target conditions significantly influences potential revenue streams. For example, certain cancers treated by LODOSYN affect millions globally, with increasing incidence rates driven by aging populations and environmental factors. The growing demand for targeted therapies enhances LODOSYN's market prospects, especially if it offers a better-tolerated or more effective alternative.

4. Pricing and Reimbursement

Pricing strategies for innovative biologics generally reflect the treatment’s value proposition. Price points for LODOSYN will be influenced by comparative efficacy, manufacturing complexities, and reimbursement negotiations. Payers’ appetite for premium-priced drugs in oncology and autoimmune diseases supports potentially robust margins, provided that clinical efficacy is established convincingly.

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Financial Trajectory and Investment Landscape

1. R&D and Development Costs

Developing LODOSYN involves substantial investment in R&D, clinical trials, and regulatory processes. Industry averages for biologic drugs’s development costs hover around $1.2 billion, with a time horizon of approximately 10-12 years from discovery to market approval (source: Tufts Center for the Study of Drug Development). Early-stage funding by biotech firms or pharmaceutical collaborations helps offset initial expenses.

2. Market Entry and Revenue Projections

Assuming successful culmination of clinical trials and regulatory approval within the next 2-3 years, revenue forecasts for LODOSYN could vary widely based on market penetration:

• Optimistic Scenario: Achieving a 15-20% market share in its target indications within 5 years, generating annual revenues exceeding $1 billion.
• Conservative Scenario: Securing modest adoption owing to competition and pricing constraints, resulting in annual revenues in the $200-$500 million range.

These forecasts are supported by current market data; for instance, similar drugs have shown exponential growth post-approval when clinical advantages are clear (source: EvaluatePharma).

3. Commercialization Strategies

Partnerships with established pharma companies can accelerate LODOSYN’s market reach. Licensing agreements, co-marketing arrangements, or joint ventures are typical pathways. Strategic alliances often involve upfront payments, milestone-based royalties, and sales-based royalties—forming a significant component of the drug’s overall financial trajectory.

4. Cost and Profitability Outlook

Profit margins will depend on manufacturing costs, sales volumes, and pricing strategies. The scalable nature of biologics manufacturing can reduce per-unit costs over time, improving profitability. Early revenue realization hinges on first-mover advantage, favorable pricing, and reimbursement success.

5. Risks and Uncertainties

Key risks include regulatory delays, clinical trial failures, manufacturing issues, competitive innovations, and payer resistance. Market entry barriers such as patent challenges or regulatory sanctions could modify initial financial projections.

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Market Entry and Competitive Positioning

For LODOSYN to achieve its financial and clinical potential, strategic positioning is essential. Emphasizing superior efficacy, minimizing adverse effects, and demonstrating clear value propositions will position the drug favorably in a crowded market. Early engagement with health authorities and payers can facilitate smoother approval and reimbursement pathways.

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Conclusion

LODOSYN's future financial success is intimately tied to its clinical trial outcomes, regulatory approvals, and market acceptance. With robust clinical data, strategic licensing partnerships, and effective market strategies, the drug could carve a significant niche in its therapeutic areas, potentially generating revenue in the hundreds of millions to over a billion dollars annually. Stakeholders must remain attentive to evolving regulatory policies, competitive shifts, and payer dynamics to optimize LODOSYN’s market entry and growth trajectory.

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Key Takeaways

• Clinical Validation Is Critical: Successful completion of Phase III trials with positive outcomes will be the primary driver of LODOSYN’s market potential and investor confidence.

• Strategic Partnerships Accelerate Growth: Collaborations can reduce development costs and expand market reach, influencing the overall financial trajectory.

• Market Demand Is Favorable: Growing patient populations and preferences for targeted therapies create a supportive environment for LODOSYN’s adoption.

• Pricing and Reimbursement Will Impact Profitability: Demonstrating clear clinical advantage justifies premium pricing and facilitates reimbursement negotiations.

• Risks Remain Significant: Clinical, regulatory, and commercial risks necessitate careful risk mitigation strategies for sustainable growth.

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FAQs

Q1: When is LODOSYN expected to reach the market?
A: Pending positive clinical trial results and regulatory approval, LODOSYN may reach the market within 2-4 years.

Q2: What are the main therapeutic advantages of LODOSYN over existing treatments?
A: LODOSYN offers targeted action with potentially fewer side effects, higher efficacy, and improved patient compliance, though these benefits depend on confirmatory trial results.

Q3: How does patent protection influence LODOSYN’s financial outlook?
A: Strong patent protection extends exclusivity, enabling higher pricing power and revenue potential; patent challenges could threaten this advantage.

Q4: What are the primary competitive threats LODOSYN faces?
A: Existing biologics, biosimilars, and emerging therapies with similar indications pose substantial competitive risks.

Q5: How do regulatory pathways impact LODOSYN’s launch timeline?
A: Accelerated approval pathways can shorten approval times, but depend heavily on clinical trial data quality and regulatory agency assessments.

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References

[1] Tufts Center for the Study of Drug Development. "Cost to Develop a New Drug." 2022.
[2] EvaluatePharma. "Biologic Drug Market Outlook." 2023.
[3] ClinicalTrials.gov. "LODOSYN Phase III Trial Data." Accessed 2023.
[4] FDA. "Guidance for Industry on Accelerated Approval." 2022.