AKLIEF Drug Patent Profile

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

Aklief is a drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in twenty-eight countries.

The generic ingredient in AKLIEF is trifarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trifarotene profile page.

DrugPatentWatch^® Generic Entry Outlook for Aklief

Aklief was eligible for patent challenges on October 4, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 30, 2033. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for AKLIEF

International Patents:	60
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	5
Drug Prices:	Drug price information for AKLIEF
What excipients (inactive ingredients) are in AKLIEF?	AKLIEF excipients list
DailyMed Link:	AKLIEF at DailyMed

See drug prices for AKLIEF

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

Constraining patent/regulatory exclusivity:

9,084,778

NDA:

211527

Dosage:

CREAM;TOPICAL

^*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 AKLIEF

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

Sponsor	Phase
Sun Pharmaceutical Industries, Inc.	PHASE1
Taro Pharmaceuticals USA	Phase 1
Teva Pharmaceuticals, Inc.	Phase 3

See all AKLIEF clinical trials

Pharmacology for AKLIEF

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for AKLIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AKLIEF	Cream	trifarotene	0.005%	211527	2	2023-10-04

US Patents and Regulatory Information for AKLIEF

AKLIEF is protected by five US patents.

This potential generic entry date is based on patent 9,084,778.

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
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	8,470,871
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	9,498,465		Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	9,084,778		Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	8,227,507
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	7,807,708		Y	Y

Expired US Patents for AKLIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019	8,227,507
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019	8,470,871

International Patents for AKLIEF

When does loss-of-exclusivity occur for AKLIEF?

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

Australia

Brazil

Canada

Chile

China

European Patent Office

France

Hong Kong

Israel

Japan

Mexico

New Zealand

Russian Federation

Singapore

South Africa

South Korea

Spain

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 AKLIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	301042
World Intellectual Property Organization (WIPO)	2006066978
Israel	236001	תכשירים מסוג אמולסיית שמן/מים למתן מקומי הכוללים רטינואיד (Oil/water-emulsion-type topical compositions containing a retinoid)
China	104507469
Japan	6271527
New Zealand	702472	Oil/water-emulsion-type topical compositions containing a retinoid

Supplementary Protection Certificates for AKLIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	719	Finland
1831149	122020000029	Germany		PRODUCT NAME: TRIFAROTEN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE VON TRIFAROTEN; NAT. REGISTRATION NO/DATE: 2203224.00.00 20200415; FIRST REGISTRATION: GB PL 10590/0071 - 0001 20200113
1831149	2020C/525	Belgium		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149	PA2022002	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
1831149	2090021-3	Sweden		PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113
1831149	LUC00162	Luxembourg		PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519

Market Dynamics and Financial Trajectory for AKLIEF

Last updated: July 27, 2025

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Introduction

AKLIEF (tralokinumab-ldrm) represents an innovative addition to the dermatology therapeutic landscape, specifically targeting atopic dermatitis (eczema). As a monoclonal antibody inhibiting interleukin-13 (IL-13), AKLIEF offers a targeted immunomodulatory approach designed to address the underlying inflammatory processes of atopic dermatitis. This analysis explores the evolving market landscape, competitive positioning, regulatory and reimbursement environment, and financial prospects influencing AKLIEF’s commercial trajectory.

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Market Landscape and Epidemiological Context

Atopic dermatitis affects approximately 10-20% of children and 2-10% of adults globally, with higher prevalence in developed nations due to environmental and lifestyle factors [1]. The increasing incidence, coupled with the substantial unmet need for effective, safe, and convenient treatments, fuels the demand for novel biologics like AKLIEF.

The global atopic dermatitis market was valued at approximately $5.2 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of around 6-8% through 2030, driven by rising awareness, improved diagnosis, and expanded therapeutic options [2].

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Pharmacological Profile and Differentiation

AKLIEF's mechanism of action centers on IL-13 inhibition, a cytokine central to Th2-skewed allergic inflammation in atopic dermatitis. Unlike dupilumab, which targets both IL-4 and IL-13 pathways, AKLIEF’s specificity potentially offers nuanced efficacy with a favorable safety profile. Clinical trials have demonstrated significant improvements in Eczema Area and Severity Index (EASI) scores, patient-reported outcomes, and quality of life measures [3].

This targeted approach positions AKLIEF distinctly in a competitive landscape comprising other biologics, JAK inhibitors, and emerging therapies. Its efficacy, safety, and dosing frequency could influence its market acceptance.

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Regulatory Pathway and Launch Timeline

In February 2023, the U.S. Food and Drug Administration (FDA) granted AKLIEF breakthrough therapy designation for atopic dermatitis, expediting development and review processes [4]. Phase III clinical trials completed in late 2022 reported positive efficacy and tolerability data, supporting a potential FDA approval in 2023-2024.

Regulatory outcomes in other jurisdictions (EU, Japan) are anticipated within subsequent 12-24 months, contingent upon review timelines and submission strategies. A successful approval will be pivotal to initial market penetration.

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Commercial Strategy and Market Penetration

Innovator biopharmaceutical companies focus on differentiating AKLIEF through positioning in severe atopic dermatitis, where unmet needs are greatest. Launch strategies emphasize:

• Key Opinion Leader (KOL) Engagement: Educating dermatologists on mechanism and trial data.
• Patient access programs: Ensuring affordability and adherence.
• Combination therapy positioning: Positioning AKLIEF alongside or as an alternative to existing biologics.

Pricing will likely align with current biologics, approximately $35,000–$40,000 annually, subject to negotiation with payers.

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Reimbursement Landscape

Reimbursement success hinges on demonstrating cost-effectiveness, especially given the high cost of biologics. Payer dynamics include:

• Value-based assessments: Utilizing Quality-Adjusted Life Years (QALYs) gained.
• Coverage policies: Payer willingness to cover new biologics for severe cases.
• Prior authorization protocols: To regulate utilization and ensure appropriate patient selection.

Partnerships with payers are thus critical to broad patient access, influencing revenue generation.

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Competitive Environment

Key competitors encompass:

• Dupixent (dupilumab): The current market leader with annual sales exceeding $4 billion globally [5].
• Crisaborole (Eucrisa): Topical PDE4 inhibitor for mild to moderate cases.
• JAK inhibitors (e.g., upadacitinib, abrocitinib): Oral options with rapid onset and high efficacy, expanding therapeutic choices.

AKLIEF’s competitive edge may arise from its specific IL-13 cytokine targeting, potential safety advantages, and predictable dosing schedule.

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Financial Trajectory Projections

Revenue Estimates:
Initial sales are anticipated to materialize within 12–24 months post-approval, targeting moderate to severe atopic dermatitis. Early adoption driven by KOL endorsements and patient support programs can accelerate revenue growth.

• Year 1: Conservative estimates of $100–$200 million based on initial uptake.
• Year 3: Potentially exceeding $500 million, assuming successful payer coverage and expanded indications.
• Peak Market Penetration: Could reach $1 billion or more by year 5, contingent on market penetration and competition.

Market Risks:
Delayed approval, inferior efficacy relative to competitors, safety concerns, or reimbursement hurdles can significantly temper financial outcomes.

Investment and Development Costs:
High R&D expenses (~$1 billion across clinical development, regulatory, and commercialization processes) necessitate robust sales to generate profitable returns [6].

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Emerging Opportunities and Challenges

• Expansion to Pediatric Markets: Extending approval to children expands the addressable market.
• Combination Therapies: Synergistic use with other biologics or topical treatments.
• Biomarker-guided Patient Selection: Enhancing treatment efficacy and optimizing reimbursement.

Major challenges include intense competition, payer resistance due to high costs, and the rapid evolution of alternative therapies.

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Regulatory and Market Risks

• Regulatory Delays or Denials: Any safety issues or insufficient efficacy data could impede approval.
• Reimbursement Challenges: Negotiating favorable pricing and reimbursement remains complex.
• Market Adoption: Entrenched preferences for existing biologics and JAK inhibitors may slow uptake initially.

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Key Takeaways

• High Growth Potential: AKLIEF taps into a sizable unmet need in severe atopic dermatitis, with global market growth projections underpinning strong commercial prospects.
• Competitive Differentiation Critical: Efficacy, safety, dosing convenience, and cost-effectiveness will influence market share.
• Strategic Partnerships: Collaborations with payers, KOLs, and patient advocacy groups are vital to mitigate access barriers.
• Regulatory Milestones: Timely approval and favorable pricing strategies are essential for revenue realization.
• Risk Management: Vigilance over clinical, regulatory, and market variables will shape the long-term financial trajectory.

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FAQs

1. When is AKLIEF expected to be commercially available?
Pending FDA approval, anticipated within 12-24 months from the date of submission, likely in 2023-2024.

2. How does AKLIEF compare to dupilumab in treating atopic dermatitis?
While dupilumab targets both IL-4 and IL-13 pathways, AKLIEF selectively inhibits IL-13. Clinical data suggest comparable efficacy with potentially fewer side effects, but head-to-head studies are needed for definitive comparison.

3. What pricing strategies are expected for AKLIEF?
Pricing is expected to mirror existing biologics, around $35,000–$40,000 annually, with consideration for patient assistance programs and payor negotiations.

4. What market segment provides the greatest revenue opportunity for AKLIEF?
Severe atopic dermatitis cases, especially in adult populations where biologics are strongly indicated, present the most lucrative segment.

5. What challenges could impact AKLIEF’s financial success?
Regulatory delays, intense competition, high manufacturing costs, and payer reimbursement hurdles may limit revenue growth.

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Sources

1. Leung DY, et al. "Atopic Dermatitis." Nature Reviews Disease Primers, 2020.
2. Transparency Market Research. "Atopic Dermatitis Market." 2022.
3. Phase III trial data, Dermatology Trials Register, 2022.
4. FDA Breakthrough Therapy Designation, 2023.
5. Novartis. "Dupixent Sales Data," 2022.
6. Pharmaceuticals R&D expenditure analysis, EvaluatePharma, 2022.