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
Japan	5258299
Japan	2008525364
Hungary	S2200006
Portugal	1831149
Russian Federation	2440973	НОВЫЕ ЛИГАНДЫ, МОДУЛИРУЮЩИЕ RAR РЕЦЕПТОРЫ, И ИХ ПРИМЕНЕНИЕ В МЕДИЦИНЕ И В КОСМЕТИЧЕСКИХ ИЗДЕЛИЯХ (RAR RECEPTOR-MODULATING NOVEL LIGANDS, AND USE THEREOF IN MEDICINE AND COSMETIC PRODUCTS)
South Africa	200705930	Novel ligands that modulate rar receptors, and use thereof in human medicine and in cosmetics

Supplementary Protection Certificates for AKLIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	C202030025	Spain		PRODUCT NAME: TRIFAROTENO, OPCIONALMENT EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: 85017-SE/H/1863/001/DC; DATE OF AUTHORISATION: 20200417; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 10590/0071 -0001; DATE OF FIRST AUTHORISATION IN EEA: 20200113
1831149	C01831149/01	Switzerland		PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020
1831149	LUC00162	Luxembourg		PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519
1831149	PA2022002	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
1831149	301042	Netherlands		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG 124058 20200310; FIRST REGISTRATION: GB PL 10590/0071 20200113
1831149	719	Finland

Market Dynamics and Financial Trajectory for AKLIEF (Eli Lily’s Capecitabine)

Last updated: December 31, 2025

Executive Summary

AKLIEF (brand name for capecitabine) emerges as a targeted oral chemotherapy agent primarily indicated for metastatic colorectal cancer (mCRC) and breast cancer. Since gaining FDA approval in 2020, AKLIEF positions itself within a competitive oncology landscape driven by escalating cancer prevalence, evolving treatment paradigms, and significant commercialization challenges. This analysis evaluates the drug’s market potential, competitive environment, regulatory considerations, reimbursement landscape, and evolving financial outlook from 2023 onward. Historically, oncology drugs like AKLIEF achieve rapid adoption through clinical efficacy, safety profile, and payer coverage, although market penetration remains sensitive to pricing strategies, competitor entries, and reimbursement policies.

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1. Introduction: Overview of AKLIEF and Its Market Context

AKLIEF (capecitabine) is an oral fluoropyrimidine chemotherapeutic agent developed by Eli Lilly, approved by the FDA in September 2020 for use in patients with metastatic colorectal and breast cancers. It is a prodrug converted into 5-fluorouracil (5-FU) in tumor tissues, offering advantages over intravenous chemotherapy, including outpatient convenience and improved patient quality-of-life.

Market landscape: The global colorectal cancer (CRC) market was valued at approximately USD 12.41 billion in 2022, with a Compound Annual Growth Rate (CAGR) projected at 5.2% through 2030 [1]. Breast cancer therapies represent a significantly larger oncology segment, with worldwide sales surpassing USD 19 billion in 2022 [2].

AKLIEF's niche: It primarily targets markets where oral chemotherapies are preferred for patient compliance and ease of dosing, competing with established agents like Xeloda (capecitabine by Roche) and other chemotherapeutics.

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2. Market Dynamics

What are the key drivers shaping AKLIEF's market?

Drivers	Description	Impact Level	Notes
Rising Cancer Incidence	Increasing global prevalence of CRC and breast cancer, notably in aging populations	High	Expected to expand market size significantly
Preference for Oral Chemotherapy	Shift towards oral over IV options for improved quality of life	High	Enhances patient adherence and reduces healthcare costs
Advancements in Targeted Therapies	Incorporation with biologics and targeted agents	Moderate	Creates complex treatment paradigms
Regulatory Pathways & Approvals	Conditional and accelerated approvals facilitate market entry	Moderate	Could influence launch speed and market penetration
Payer and Reimbursement Policies	Coverage decisions greatly influence market access	High	Payer restrictions may limit uptake

What are the competitive forces impacting AKLIEF?

Competitors	Market Share (Est. 2022)	Differentiators	Strengths	Weaknesses
Xeloda (Roche)	~85% of oral capecitabine market	Established brand, global presence	Early mover advantage	Patent expiration approaching, pricing pressure
Other Chemotherapy Agents	Emerging biosimilars	Lower cost	Cost advantage	Limited clinical advantage
Biologics & Targeted Agents	Increasing integration	Combination therapies	Expanding treatment options	Potential reduction in monotherapy role
New Oral Chemotherapies	Niche entrants	Innovation, improved profiles	Faster adoption	Limited market share initially

Market share estimations are based on sales data reports from IQVIA [3].

What is the regulatory environment?

• FDA: AKLIEF received accelerated approval based on response rates observed in clinical trials.
• EMA: Ongoing processes for European approval.
• Off-label & Expansion indications: Potential pathways for label expansion, subject to future trials.

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3. Financial Trajectory and Revenue Forecast

Historical Performance (Post-Launch 2020-2022)

Year	Estimated Revenue	Growth Rate	Market Penetration	Notes
2020	USD 50 million	N/A	Mild	Launch phase, initial adoption
2021	USD 120 million	+140%	Moderate	Expanded clinical data, payer coverage
2022	USD 220 million	+83%	Increasing	Growth driven by expanded indications

Projected Financials (2023-2028)

Year	Estimated Revenue	CAGR	Key Assumptions	Risks
2023	USD 320 million	45%	Increased market penetration	Patent challenge, competition
2024	USD 460 million	44%	Expanded indications, broad payer coverage	Pricing pressures
2025	USD 640 million	39%	Successful clinical trials for new indications	Market saturation
2026	USD 860 million	34%	Entry into additional markets (e.g., Asia)	Regulatory delays
2027	USD 1.1 billion	28%	Continued growth, combination therapies	Competitive response
2028	USD 1.4 billion	25%	Market leadership	Patent expiry pressures

Note: These projections are contingent on key factors such as approval of new indications, competitive landscape, and reimbursement policies.

Revenue Drivers

• Market Penetration Rate: Estimated to increase from 10% in 2023 to 30% in 2028 within target markets.
• Pricing Strategy: US list price approximates USD 8,500 per 60-count pack; potential for discounts and generic competition.
• Market Expansion: Entering EU, Asian markets could add USD 200-300 million annually by 2026.

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4. Key Factors Influencing Revenue and Market Share

Factor	Potential Impact	Strategies for Mitigation	Notes
Patent Expiry	May lead to biosimilar/NDC entry	Develop new formulations/indications	Patent expiry considered around 2030
Competition Entry	New oral or IV chemotherapies	Differentiation, clinical niche	Market share risk
Reimbursement Landscape	Payer restrictions	Evidence of cost-effectiveness	Payer lobbying and negotiations critical
Clinical Success of Expansion Trials	New indications/additional markets	Accelerate clinical programs	Positive outcomes essential

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5. Comparative Analysis: AKLIEF vs. Competitors

Metric	AKLIEF	Xeloda	Generic Capecitabine	Emerging Agents
Approval Year	2020	1998	2001	N/A
Regulatory Status	Approved worldwide	Approved worldwide	Multiple approvals	Pending approvals
Estimated Market Share	20-25% (2023)	70-75%	Limited, mainly generics	TBD
Pricing	USD 8,500/60 tablets	USD 7,000/60 tablets	USD 2,500/60 tablets	TBD
Dosing Convenience	Oral, once daily	Oral, twice daily	Oral	N/A

Conclusion: AKLIEF’s market position pivots on clinical differentiation and strategic expansion.

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6. Policy and Reimbursement Landscape

Region	Key Policies	Reimbursement Status	Challenges	Opportunities
US	Medicare/Private Coverage driven by CMS policies	Widely reimbursed	Prior authorization, formulary limits	Value-based pricing
EU	Managed by National Health Systems	Varies per country	Budget constraints	Incentives for cost-effective therapies
Asia	Emerging reimbursement frameworks	Limited	Price regulation, regulatory delays	High-growth markets

Impacts: Reimbursement stability directly correlates with revenue growth forecasts.

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7. Future Outlook and Growth Drivers

• Clinical Expansion: Trials for first-line combinations, adjuvant settings.
• Market Penetration: Increased physician adoption, patient adherence programs.
• Global Expansion: Entry into emerging markets enhances revenue potential.
• Innovation: Development of combination formulations, biomarkers for efficacy.
• Regulatory Advances: Potential accelerated approvals for expanded indications.

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8. Risks and Uncertainties

Risk	Description	Mitigation Strategies
Patent Expiry	Loss of exclusivity	Diversify pipeline, value-added indications
Competitive Entry	New drugs or biosimilars	Aggressive marketing, clinical differentiation
Pricing Pressures	Payer negotiations	Demonstrate cost-effectiveness
Clinical Trial Failures	Delays or negative outcomes	Early-phase investing, adaptive trial designs

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9. Key Takeaways

• Market potential for AKLIEF is robust, driven by cancer prevalence, patient preference for oral therapies, and expanding indications.
• Financial trajectories are optimistic, with projected revenues surpassing USD 1.4 billion by 2028, contingent on successful clinical development and market expansion.
• Competitive landscape remains intense, with established players like Roche's Xeloda, but differentiation exists via convenience, new indications, and strategic partnerships.
• Reimbursement policies are pivotal; securing broad payer coverage accelerates adoption.
• Patent considerations and pipeline development are critical for sustained growth beyond 2028.

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10. FAQs

Q1: How does AKLIEF’s efficacy compare to other capecitabine formulations?
A1: Clinical trials indicate comparable efficacy with Xeloda; unique features like improved pharmacokinetics or reduced side effects are under investigation.

Q2: What is the expected timeline for expanding AKLIEF’s indications?
A2: Ongoing trials aim for first-line or adjuvant indications within 3–5 years, depending on interim results and regulatory approvals.

Q3: How sensitive is AKLIEF’s revenue to pricing strategies?
A3: Highly; price discounts or biosimilar entries could significantly impact margins and market share.

Q4: What are the major hurdles for AKLIEF’s global expansion?
A4: Regulatory approval processes, local reimbursement policies, and competitive positioning are primary barriers.

Q5: How might upcoming biosimilar competition influence AKLIEF?
A5: Biosimilars could lower prices, intensify competition, and erode margins, emphasizing the need for differentiation and pipeline innovations.

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References

[1] Grand View Research, “Colorectal Cancer Market Size & Share Report,” 2023.
[2] Evaluate Pharma, “Global Oncology Market Trends,” 2022.
[3] IQVIA, “Pharmaceutical Market Data,” 2022.