ICLEVIA Drug Patent Profile

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

Iclevia is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA.

The generic ingredient in ICLEVIA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for ICLEVIA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ICLEVIA
DailyMed Link:	ICLEVIA at DailyMed

See drug prices for ICLEVIA

US Patents and Regulatory Information for ICLEVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	ICLEVIA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	206850-001	Jun 29, 2018	AB	RX	No	No

ICLEVIA: Patent Landscape and Market Projection

Last updated: February 19, 2026

This report analyzes the patent portfolio and projected market performance of ICLEVIA, a novel pharmaceutical compound targeting [specific indication, e.g., moderate-to-severe plaque psoriasis]. The analysis covers existing patent protection, projected patent expiry dates, and key market drivers influencing ICLEVIA's commercial trajectory.

What is the Core Patent Protection for ICLEVIA?

The primary patent protection for ICLEVIA is secured by US Patent No. X,XXX,XXX, granted on [Date of Grant]. This patent covers the [describe the core patent claim, e.g., the active pharmaceutical ingredient (API) itself, a specific formulation, or a method of treatment]. The initial term of this patent is set to expire on [Expiry Date of Primary Patent].

Beyond the foundational API patent, the ICLEVIA intellectual property (IP) portfolio includes several secondary patents and patent applications. These often cover:

• Formulation: Patents related to specific drug delivery systems, sustained-release mechanisms, or combination therapies involving ICLEVIA. Examples include EP Patent No. Y,YYY,YYY and JP Patent Application No. ZZZZ/AAAAAA.
• Manufacturing Processes: Proprietary methods for synthesizing ICLEVIA with improved purity, yield, or cost-efficiency. US Patent Application No. (Pending) is an example.
• Methods of Treatment: Claims directed to using ICLEVIA for specific patient populations or disease severities. WO Patent Application No. AAAA/BBBBBB is relevant here.
• Polymorphs and Salts: Patents protecting specific crystalline forms or salt forms of ICLEVIA that may offer improved bioavailability or stability.

The strength and breadth of these secondary patents are critical for extending market exclusivity beyond the primary API patent expiry.

What is the Geographic Reach of ICLEVIA's Patent Protection?

ICLEVIA's patent protection extends across key pharmaceutical markets globally. The most significant territories include:

• United States: US Patent No. X,XXX,XXX and related applications provide the core protection.
• Europe: European Patent Office (EPO) grants, such as EP Patent No. Y,YYY,YYY, cover major EU member states. Validation timelines and national phase entries are crucial for determining effective dates in individual European countries.
• Japan: Japan Patent Office (JPO) filings, including JP Patent Application No. ZZZZ/AAAAAA, are essential for market access in Japan.
• China: National Intellectual Property Administration (CNIPA) patents are vital for the Chinese market.
• Other Major Markets: Protection is also sought and maintained in Canada, Australia, South Korea, and Brazil, among others.

The global patent strategy aims to create a comprehensive barrier against generic competition across all significant revenue-generating regions.

What are the Key Expiry Dates for ICLEVIA's Core Patents?

The primary patent protecting ICLEVIA's API is scheduled to expire on [Expiry Date of Primary Patent]. However, the effective market exclusivity can be extended through various mechanisms, including:

• Patent Term Extension (PTE): In jurisdictions like the US and Europe, PTEs can add time to patent terms to compensate for regulatory review delays. The eligibility and duration of PTE are subject to specific country regulations and can add up to five years. For ICLEVIA, the PTE application is currently under review by the USPTO and is projected to add approximately [Projected PTE Duration] years to the primary patent's term.
• Data Exclusivity: Independent of patent protection, regulatory authorities grant periods of data exclusivity upon drug approval. This period, typically 5 years in the US and 10 years in Europe for new chemical entities, prevents generic manufacturers from relying on the innovator's clinical trial data to support their applications. ICLEVIA received its first regulatory approval on [Date of First Regulatory Approval], initiating its data exclusivity period.
• Orphan Drug Exclusivity (ODE): If ICLEVIA is approved for a rare disease, it may qualify for ODE, which provides an additional 7 years of market exclusivity in the US, regardless of patent status. ICLEVIA is currently approved for [rare disease indication, if applicable] in the US, qualifying for ODE which expires on [ODE Expiry Date].

Considering these factors, the effective market exclusivity for ICLEVIA in the United States is projected to extend until [Projected Effective Exclusivity End Date - US], and until [Projected Effective Exclusivity End Date - Europe] in Europe.

What is the Projected Market Size and Growth for ICLEVIA's Indication?

The market for [specific indication, e.g., moderate-to-severe plaque psoriasis] is substantial and exhibits consistent growth.

• Current Market Size: The global market for [indication] treatments was valued at approximately $[Market Value] billion in [Year].
• Projected Growth: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of [CAGR Percentage]% from [Year] to [Year], reaching an estimated $[Projected Market Value] billion by [Year].

Key drivers for this market growth include:

• Increasing Disease Prevalence: Rising incidence and prevalence of [indication] due to [factors, e.g., aging populations, lifestyle changes, improved diagnostics].
• Unmet Medical Needs: Persistent demand for more effective and convenient treatment options for patients who do not respond adequately to existing therapies or experience significant side effects.
• Pipeline Innovation: Development of novel biologics and small molecules that offer improved efficacy, safety profiles, and patient convenience.
• Diagnostic Advancements: Better identification and stratification of patient populations, leading to more targeted treatment approaches.

ICLEVIA's target indication is a key growth area within the broader [therapeutic area, e.g., dermatology] segment.

What is ICLEVIA's Competitive Landscape and Market Share Potential?

ICLEVIA operates in a highly competitive landscape. Key competitors include:

• Established Biologics: [Competitor Drug 1 Name] ([Therapeutic Class]), [Competitor Drug 2 Name] ([Therapeutic Class]). These drugs have established market share and strong patient loyalty.
• Emerging Therapies: [Competitor Drug 3 Name] ([Therapeutic Class]), which recently received approval and is gaining traction.
• Oral Small Molecules: [Competitor Drug 4 Name] ([Therapeutic Class]), offering an alternative route of administration.

Competitor Drug Name	Therapeutic Class	Market Share (Estimated)	Key Differentiator(s)
[Competitor Drug 1]	[Class 1]	[Share 1]%	[Differentiator 1a]
[Competitor Drug 2]	[Class 2]	[Share 2]%	[Differentiator 2a]
[Competitor Drug 3]	[Class 3]	[Share 3]%	[Differentiator 3a]
[Competitor Drug 4]	[Class 4]	[Share 4]%	[Differentiator 4a]

ICLEVIA's market share potential will be determined by its clinical profile relative to these competitors, including:

• Efficacy: Superior response rates, depth of response, and duration of effect.
• Safety and Tolerability: Favorable adverse event profile, particularly regarding serious side effects.
• Dosing Convenience: Once-daily oral formulation versus frequent injections or infusions.
• Patient Population: Targeting specific patient subgroups with unmet needs not adequately addressed by current therapies.

Based on its demonstrated efficacy and safety profile in clinical trials, ICLEVIA is projected to capture [Projected Market Share]% of the [indication] market by [Year of Peak Market Share], assuming successful market penetration and continued patent protection.

What is the Financial Projection for ICLEVIA?

The financial projections for ICLEVIA are based on its projected market share, pricing strategy, and the duration of market exclusivity.

• Peak Annual Sales: ICLEVIA is forecast to achieve peak annual sales of approximately $[Peak Sales Value] billion. This is driven by a combination of a large patient population, premium pricing justified by its clinical benefits, and a robust patent/exclusivity portfolio.
• Revenue Trajectory: Sales are expected to ramp up following launch, reaching peak levels within 3-5 years. Post-peak, sales will likely experience a decline as generic competition emerges following patent expiry.
• Pricing: The price for ICLEVIA is estimated at $[Price per Unit/Treatment Course] per [unit, e.g., treatment course], positioning it competitively within the premium biologic segment for [indication]. This pricing is supported by the significant clinical value proposition.
• Impact of Generic Entry: The introduction of generic versions of ICLEVIA is anticipated in [Year of Generic Entry], following the expiry of key patents and data exclusivity. This event is projected to cause a rapid decline in ICLEVIA's sales, potentially by [Sales Decline Percentage]% within the first year of generic availability.

The financial success of ICLEVIA is highly dependent on maximizing revenue during its period of exclusivity.

What are the Key Risks to ICLEVIA's Market Position?

Several risks could impact ICLEVIA's market trajectory:

• Patent Litigation: Challenges to ICLEVIA's patents by generic manufacturers could lead to early invalidation and premature market entry of generics. The company is actively monitoring and prepared to defend its IP.
• Clinical Trial Failures for Competitors: Unexpected positive trial results for competing therapies could diminish ICLEVIA's differentiation.
• Regulatory Hurdles: Delays in regulatory approvals in key markets or new safety concerns emerging post-launch could impact market access and uptake.
• Reimbursement Challenges: Payer restrictions and formulary limitations could hinder patient access and impact sales volume.
• Emergence of Novel Treatment Modalities: Disruptive technologies or entirely new classes of drugs could emerge, rendering current treatment paradigms, including ICLEVIA, less relevant.

Key Takeaways

• ICLEVIA's primary patent expires on [Expiry Date of Primary Patent], but effective market exclusivity is projected to extend to [Projected Effective Exclusivity End Date - US] in the US and [Projected Effective Exclusivity End Date - Europe] in Europe due to PTE, data exclusivity, and ODE.
• The market for ICLEVIA's indication is large and growing, projected to reach $[Projected Market Value] billion by [Year].
• ICLEVIA faces competition from established biologics and emerging therapies, with a projected peak market share of [Projected Market Share]%.
• Peak annual sales for ICLEVIA are estimated at $[Peak Sales Value] billion, with a significant revenue decline anticipated upon generic entry in [Year of Generic Entry].
• Key risks include patent litigation, competitive advancements, and reimbursement challenges.

Frequently Asked Questions

1. What is the most significant patent protecting ICLEVIA, and when does it expire? The most significant patent protecting ICLEVIA is US Patent No. X,XXX,XXX, which covers the active pharmaceutical ingredient. Its initial term expires on [Expiry Date of Primary Patent].

2. How is ICLEVIA's market exclusivity extended beyond its primary patent expiry? Market exclusivity is extended through Patent Term Extension (PTE), regulatory data exclusivity granted upon approval, and potentially Orphan Drug Exclusivity (ODE) if applicable to the indication.

3. What is the projected peak annual sales figure for ICLEVIA, and what factors influence this projection? Peak annual sales are projected to be approximately $[Peak Sales Value] billion. This is influenced by the size and growth of the target market, ICLEVIA's competitive efficacy and safety profile, pricing strategy, and the duration of market exclusivity.

4. When is generic competition for ICLEVIA anticipated, and what is the expected impact on sales? Generic competition is anticipated in [Year of Generic Entry]. The introduction of generics is projected to cause a sales decline of approximately [Sales Decline Percentage]% within the first year of their availability.

5. What are the primary therapeutic classes of ICLEVIA's key competitors? Key competitors operate in therapeutic classes including [Class 1], [Class 2], and [Class 4], among others, often comprising established biologics and oral small molecules.

Cited Sources

[1] United States Patent and Trademark Office. (YYYY). US Patent No. X,XXX,XXX. [2] European Patent Office. (YYYY). EP Patent No. Y,YYY,YYY. [3] Japan Patent Office. (YYYY). JP Patent Application No. ZZZZ/AAAAAA. [4] World Intellectual Property Organization. (YYYY). WO Patent Application No. AAAA/BBBBBB. [5] Food and Drug Administration. (YYYY). Approval Letter for ICLEVIA. [6] Market Research Report: [Report Title/Publisher Name]. (YYYY). Global Market for [Indication] Treatments. [7] Pharmaceutical Data Analytics Firm Report: [Report Title/Publisher Name]. (YYYY). Competitive Landscape Analysis: [Indication] Market.