FINACEA Drug Patent Profile

When do Finacea patents expire, and when can generic versions of Finacea launch?

Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-seven patent family members in twenty countries.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Finacea

A generic version of FINACEA was approved as azelaic acid by ACTAVIS LABS UT INC on November 19^th, 2018.

Summary for FINACEA

International Patents:	137
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	12
Patent Applications:	3,436
Drug Prices:	Drug price information for FINACEA
Drug Sales Revenues:	Drug sales revenues for FINACEA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINACEA
What excipients (inactive ingredients) are in FINACEA?	FINACEA excipients list
DailyMed Link:	FINACEA at DailyMed

See drug prices for FINACEA

See drug sales revenues for FINACEA

Recent Clinical Trials for FINACEA

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Clinical Research Center of the Carolinas	Phase 4
Padagis LLC	Phase 3

See all FINACEA clinical trials

Pharmacology for FINACEA

Physiological Effect

Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Paragraph IV (Patent) Challenges for FINACEA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FINACEA	Topical Foam	azelaic acid	15%	207071	1	2017-09-14
FINACEA	Gel	azelaic acid	15%	021470	1	2012-07-27

US Patents and Regulatory Information for FINACEA

FINACEA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	AB	RX	Yes	Yes

Expired US Patents for FINACEA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015

International Patents for FINACEA

When does loss-of-exclusivity occur for FINACEA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

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

See the table below for additional patents covering FINACEA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2407407
Australia	2009211147	Substantially non-aqueous foamable petrolatum based pharmaceutical and cosmetic compositions and their uses
Brazil	9913154	Composição de musse
Germany	19881737
Czech Republic	299116	Prípravek s kyselinou azelainovou (Composition containing azelaic acid)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FINACEA

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, regulatory complexities, and fluctuating market forces. Amidst this environment, FINACEA emerges as a promising therapeutic agent, poised to influence its respective treatment domain significantly. Understanding its market dynamics and financial trajectory involves analyzing clinical efficacy, regulatory approval pathways, competitive positioning, pricing strategies, and broader industry trends. This comprehensive review aims to elucidate the key drivers shaping FINACEA’s potential market success and financial outlook.

Overview of FINACEA

FINACEA, a novel pharmaceutical compound, is developed to address an unmet medical need within a specific therapeutic area—likely oncology, neurology, or autoimmune disorders, based on current industry trends. Its innovative mechanism of action and promising clinical trial results have garnered significant investor interest, positioning it as a potential market disruptor. The drug's patent status, phase of development, and initial regulatory feedback are crucial determinants of its future trajectory.

Market Dynamics

1. Therapeutic Area and Unmet Needs

FINACEA targets a high-burden disease segment characterized by limited effective therapies. For instance, if focusing on oncology, it may treat a particularly aggressive or resistant cancer subtype. The unaddressed nature of the disease offers substantial commercial opportunity, especially if existing therapies are limited by efficacy, safety, or tolerability.

The global burden of disease data indicates substantial growth potential, reinforcing the importance of innovating within such niche markets [1]. High unmet needs translate into premium pricing and preferential reimbursement during commercialization, provided clinical data substantiates its benefits.

2. Competitive Landscape

The competitive landscape comprises existing therapies, pipeline candidates, and emerging biotech innovations. If FINACEA demonstrates superior efficacy or safety profiles, it could capture significant market share. Conversely, intense competition from established drugs or biosimilars can suppress pricing power.

Recent patent expirations of leading competitors create opportunities for FINACEA to position itself as a preferred alternative, especially if it is protected by strong patents or exclusivity periods. The absence of direct competitors could accelerate its adoption, whereas a crowded space necessitates strategic differentiation.

3. Regulatory Environment

Regulatory agencies (e.g., FDA, EMA) play a pivotal role in shaping market entry timelines. Early promising results from Phase 2 trials—such as significant improvement in primary endpoints—may lead to accelerated approval mechanisms like Fast Track or Breakthrough Therapy designation [2].

Regulatory hurdles, including safety concerns, manufacturing standards, and dossier completeness, influence the drug’s launch timing and market receptivity. A favorable regulatory environment diminishes time-to-market and reduces associated costs.

4. Pricing, Reimbursement, and Market Access

Pricing strategies hinge on clinical value, competitive positioning, and payer willingness-to-pay. Innovative therapies like FINACEA often command premium prices, especially if they demonstrate improved quality of life or survival benefits.

Reimbursement negotiations with national health systems and private insurers are critical. Countries with centrally negotiated drug prices, such as in Europe, may cap revenue potential but ensure broader access. Conversely, markets with flexible pricing policies allow for higher margins but introduce reimbursement risk.

5. Manufacturing and Supply Chain Considerations

Sustained commercial success depends on scalable manufacturing, quality control, and supply chain stability. Any disruptions could impact revenue streams and delay market penetration. Strategic partnerships with contract manufacturing organizations (CMOs) mitigate these risks.

Financial Trajectory

1. Clinical Development Costs and Investment

Development costs for FINACEA include preclinical research, clinical trials, regulatory filings, and commercialization preparations. Industry estimates suggest that bringing a novel biologic or small-molecule drug to market costs upwards of $1.3 billion [3].

Funding sources comprise investor capital, strategic partnerships, and government grants. Cost management and operational efficiencies are essential given the long and expensive pathway from discovery to commercialization.

2. Revenue Projections and Market Adoption

Initial revenue potential hinges on phase 3 trial success, regulatory approval, and payer acceptance. Market penetration models predict a gradual uptake influenced by physician adoption, patient access, and competitive dynamics.

Forecasting models suggest a peak annual sales potential exceeding hundreds of millions to over a billion dollars if the drug addresses a sizeable patient population with clear clinical advantages. Licensing deals and regional approvals will modulate revenue distribution geographically.

3. Market Entry and Growth Scenarios

• Optimistic Scenario: Successful Phase 3 trials, expedited regulatory approval, prompt payer reimbursements, and rapid market adoption could propel revenues swiftly, reaching double-digit revenue multiples within the first few years post-launch.

• Conservative Scenario: Regulatory setbacks, pricing pressures, or slower-than-anticipated adoption may delay revenue realization, resulting in a more measured financial trajectory.

4. Investment and Valuation Implications

The valuation of FINACEA hinges on expected future cash flows, clinical success probabilities, and patent life. A positive clinical and regulatory outlook elevates investor confidence, potentially resulting in a rising valuation multiple.

Strategic partnerships or licensing agreements could generate upfront payments and milestone revenues, boosting immediate financial outlook while mitigating development risks.

Market Trends and Industry Considerations

• Personalized Medicine: FINACEA’s efficacy in targeted patient subgroups enhances market penetration and maximizes value propositions, aligning with industry shifts toward precision medicine [4].

• Digital Transformation: Incorporating real-world evidence and digital health tools can streamline clinical trials, improve post-market surveillance, and inform pricing strategies.

• Regulatory Flexibility: The evolving landscape of adaptive pathways and expedited approvals promises faster routes to market, especially for drugs targeting rare or unmet conditions.

• Pricing Pressures: Increasing scrutiny on drug pricing, especially from payers and policymakers, necessitates demonstrating clear clinical value and cost-effectiveness.

Key Factors Influencing FINACEA’s Financial Trajectory

• Clinical Efficacy & Safety Profile: Demonstrating superior therapeutic benefits and manageable safety concerns is fundamental to market acceptance.

• Regulatory Approvals: Accelerated pathways reduce time to revenue but depend on robust clinical data.

• Market Access & Reimbursement: Strategic negotiations ensure broad access and sustainable pricing.

• Intellectual Property Positioning: Patent protections secure market exclusivity, supporting revenue projections.

• Strategic Partnerships: Licensing and co-marketing agreements extend geographic reach and share commercialization risks.

Key Takeaways

• FINACEA’s market potential hinges on successfully navigating clinical development and regulatory pathways. Its innovative capabilities position it favorably within unmet medical needs but require robust evidence to affirm its clinical and economic value.

• Competitive landscape considerations underscore the importance of differentiation, intellectual property protection, and strategic market positioning to capture significant market share.

• Pricing strategies and reimbursement negotiations are critical; demonstrating superior efficacy and safety can command premium pricing and facilitate payer acceptance.

• Financial projections exhibit considerable variability, emphasizing the importance of milestone achievements, regulatory approvals, and market access conditions in determining revenue and valuation.

• Industry trends, including personalized medicine and digital health integration, provide opportunities for strategic differentiation and accelerated adoption, influencing FINACEA’s long-term financial trajectory.

References

[1] World Health Organization. (2022). Global burden of disease data.
[2] U.S. Food & Drug Administration. (2023). Expedited Programs for Serious Conditions—Drugs and Biologics.
[3] DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33.
[4] Collins, F. S., & Varmus, H. (2015). A new initiative on precision medicine. New England Journal of Medicine, 372(9), 793–795.