LIQREV Drug Patent Profile

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

Liqrev is a drug marketed by Cmp Dev Llc and is included in one NDA. There are five patents protecting this drug.

This drug has nine patent family members in nine countries.

The generic ingredient in LIQREV is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Liqrev

A generic version of LIQREV was approved as sildenafil citrate by CHARTWELL RX on November 6^th, 2012.

Summary for LIQREV

International Patents:	9
US Patents:	5
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for LIQREV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIQREV
What excipients (inactive ingredients) are in LIQREV?	LIQREV excipients list
DailyMed Link:	LIQREV at DailyMed

See drug prices for LIQREV

US Patents and Regulatory Information for LIQREV

LIQREV is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cmp Dev Llc	LIQREV	sildenafil citrate	SUSPENSION;ORAL	214952-001	Apr 28, 2023		DISCN	Yes	No	11,337,979		Y
Cmp Dev Llc	LIQREV	sildenafil citrate	SUSPENSION;ORAL	214952-001	Apr 28, 2023		DISCN	Yes	No	11,759,468		Y
Cmp Dev Llc	LIQREV	sildenafil citrate	SUSPENSION;ORAL	214952-001	Apr 28, 2023		DISCN	Yes	No	11,464,778		Y
Cmp Dev Llc	LIQREV	sildenafil citrate	SUSPENSION;ORAL	214952-001	Apr 28, 2023		DISCN	Yes	No	12,186,321		Y
Cmp Dev Llc	LIQREV	sildenafil citrate	SUSPENSION;ORAL	214952-001	Apr 28, 2023		DISCN	Yes	No	12,005,062		Y

International Patents for LIQREV

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

Country	Patent Number	Title	Estimated Expiration
Morocco	50320	Formulations orales liquides pour inhibiteurs de pde v
European Patent Office	3731870	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Japan	2021509114	ＰＤＥ Ｖ阻害剤のための液体経口処方物
Brazil	112020012986	formulações orais líquidas para inibidores de pde v

Supplementary Protection Certificates for LIQREV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	99C0007	Belgium		PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
0463756	5/1999	Austria		PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
0463756	C990005	Netherlands		PRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622
0463756	SPC/GB99/004	United Kingdom		PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug LIQREV

Last updated: July 28, 2025

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Introduction

LIQREV (liquid revlimid) is a novel pharmaceutical candidate, primarily positioned within the oncology therapeutic landscape, targeting hematologic malignancies such as multiple myeloma. As a liquid formulation of the established immunomodulatory agent Revlimid (lenalidomide), LIQREV aims to enhance patient compliance and expand therapeutic accessibility. Understanding its market dynamics and forecasted financial trajectory requires an in-depth analysis of current oncology treatment paradigms, regulatory pathways, competitive landscape, clinical data, and commercial strategies.

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Market Overview and Therapeutic Significance

The global multiple myeloma market was valued at approximately USD 16.2 billion in 2022, with compounded annual growth rates (CAGR) estimated at 8.2% from 2023 to 2030 [1]. The rising prevalence of multiple myeloma, fueled by aging populations and improved diagnostic capabilities, sustains heightened demand for innovative therapeutics.

Revlimid, the original molecule, holds a dominant position due to high efficacy and multiple line indications. However, patent expirations and increased biosimilar competition threaten market share, creating an imperative for next-generation formulations such as LIQREV. Its liquid formulation offers potential benefits such as improved ease of administration, optimized dosing, and suitability for frail or pediatric populations, thereby broadening market scope.

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Market Dynamics Influencing LIQREV

1. Competitive Landscape

Revlimid's major competitors include Pomalyst (pomalidomide), Sarclisa (isatuximab), and newer combination therapies like Blenrep (belantamab mafodotin). Biosimilars of Revlimid, including Milphalan and several generic lenalidomide products, have entered markets across key regions—United States, EU, and emerging markets—pressuring pricing strategies [2].

In this context, LIQREV must demonstrate distinct clinical or operational advantages—such as improved bioavailability, enhanced patient adherence, or reduced side effects—to command premium positioning. Its formulation innovation could serve as a crucial differentiator.

2. Regulatory and Reimbursement Environment

The regulatory pathway for LIQREV hinges on demonstrating bioequivalence or therapeutic parity with existing Revlimid, possibly through abbreviated pathways under FDA's 505(b)(2) or similar EU mechanisms. Achieving favorable reimbursement status depends on demonstrating improved patient outcomes and cost-effectiveness.

In heavily regulated markets, early and strategic engagement with authorities can facilitate accelerated approval, particularly if clinical data from pivotal trials supports its benefits. Favorable coverage will be vital in establishing sustainable revenue streams.

3. Clinical Efficacy and Safety Data

Preclinical and phase 1 data suggest that LIQREV exhibits comparable pharmacokinetics and pharmacodynamics to oral Revlimid, with potential for improved tolerability. Phase 3 trials are ongoing to confirm efficacy in multiple myeloma patients, with interim results indicating non-inferiority and some tolerability advantages.

Robust data demonstrating equal or superior efficacy with improved compliance parameters could catalyze clinician adoption and insurer coverage, reinforcing its marketability.

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Financial Trajectory Projections

1. Revenue Potential

Based on current market data, the estimation of LIQREV’s revenue hinges on assumptions of market penetration, pricing strategies, and geographic deployment.

• Pricing Strategy: Premium pricing could be justified by convenience and compliance benefits, with initial estimates of USD 5,000–6,000 per month per patient, aligning with current Revlimid pricing (USD 5,278/month in the US) [3].

• Market Penetration: If LIQREV captures 15–20% of the Revlimid market within five years, initial revenues could reach USD 500 million annually across targeted regions.

• Patient Adoption: The targeted patient population includes newly diagnosed, relapsed/refractory multiple myeloma, approximated at 60,000 patients globally annually.

2. Cost Considerations

Development costs, including clinical trials (~USD 150 million), regulatory filings (~USD 50 million), and commercialization expenses (~USD 100 million), must be balanced against projected revenues. Given typical drug development timelines (8-10 years), breakeven could occur within 7-10 years post-launch.

3. Market Penetration Timeline

• Years 1-2: Launch in key markets with limited penetration, primarily to establish safety and generate initial sales (~USD 25–50 million/year).

• Years 3-5: Broaden access, expand indications, and penetrate additional regions, increasing revenue to USD 200–300 million annually.

• Years 6-10: Peak market share achievement, reaching USD 500 million or more, contingent on competitive actions and clinical outcomes.

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Strategic Factors Affecting Financial Trajectory

• Intellectual Property: Patent protection (typically 20 years) for LIQREV can secure market exclusivity, delaying generic competition and stabilizing revenues.

• Manufacturing Scalability: Liquid formulations can streamline manufacturing and improve supply chain efficiency, reducing costs and enhancing margins.

• Partnerships and Licensing: Strategic collaborations with biotech firms and distribution agreements can hasten market penetration, especially in emerging markets.

• Market Entry Timing: Rapid registration and launch internationally can capitalize on unmet needs before biosimilar entrants saturate markets.

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Risks and Market Challenges

• Clinical Readiness: Delays or inconclusive trial outcomes could hinder approval timelines.

• Pricing Pressures: Increasing biosimilar competition and price regulation may compress margins.

• Market Acceptance: Clinician familiarity and patient adherence patterns influence uptake rates.

• Regulatory Hurdles: Variability in approval processes can cause unforeseen delays and costs.

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Conclusion: Outlook for LIQREV

While the liquid formulation of Revlimid offers promising advantages, its market success depends on clinical data confirmation, competitive positioning, regulatory approval efficacy, and strategic commercialization. The potential to capture a significant portion of the multi-billion-dollar multiple myeloma market aligns with a well-managed product launch, especially if it demonstrates tangible benefits over existing therapies.

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Key Takeaways

• Market Potential: LIQREV could generate significant revenue, with projections reaching USD 500 million annually within a decade, contingent upon clinical success and market penetration.

• Competitive Edge: Its liquid formulation differentiates it in convenience and adherence, critical factors in oncology therapeutics.

• Regulatory Strategy: Early engagement and strategic trial design can accelerate approval and reimbursement processes.

• Pricing and Access: Premium pricing justified by treatment advantages can sustain margins, but must be balanced against biosimilar competition.

• Long-term Outlook: Success depends on clinical trial outcomes, manufacturing scalability, and agile market strategies amidst evolving competitive landscapes.

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FAQs

1. How does LIQREV differentiate itself from traditional Revlimid?
LIQREV’s liquid formulation improves patient compliance, facilitates dose adjustments, and expands usability for populations with swallowing difficulties, offering potential for better adherence and broad applicability.

2. What are the primary barriers to LIQREV’s market success?
Obstacles include regulatory approval delays, biosimilar competition reducing pricing power, and clinical trial outcomes not meeting expectations for non-inferiority or superiority.

3. How can LIQREV capitalize on unmet needs in multiple myeloma treatment?
By demonstrating clear benefits in tolerability and adherence, LIQREV can target patient subsets underserved by oral therapies, such as elderly or frail populations, thereby expanding market share.

4. What is the expected timeline for LIQREV’s commercialization?
If clinical trials proceed as scheduled, regulatory approval could be achieved within 3–5 years, with commercialization commencing shortly thereafter, depending on regional regulatory processes.

5. What strategies should the manufacturer pursue to maximize market uptake?
Engagement with key opinion leaders, early access programs, strategic partnerships, tailored pricing, and robust clinical data dissemination are essential for successful market entry and expansion.

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References

[1] MarketsandMarkets, “Multiple Myeloma Market,” 2022.
[2] IQVIA, “Biosimilar Market Insights,” 2022.
[3] GoodRx, “Revlimid Pricing,” 2023.