AKLIEF Drug Patent Profile

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

Aklief is a drug marketed by Galderma Labs Lp and is included in one NDA. There are three 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 July 19, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AKLIEF

International Patents:	60
US Patents:	3
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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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:

7,807,708

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 USA	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 three US patents.

This potential generic entry date is based on patent 7,807,708.

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	9,084,778		Y
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	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

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

Country	Patent Number	Title	Estimated Expiration
Argentina	055297	LIGANDOS MODULADORES DE LOS RECEPTORES RARS, UTILIZACION EN MEDICINA HUMANA ASI COMO EN COSMETICA
Austria	E542791
Australia	2005318292	Novel ligands that modulate RAR receptors, and use thereof in human medicine and in cosmetics
Brazil	PI0517500	compostos, uso de uma composição, composição farmacêutica, composição cosmética, uso não-terapêutico de uma composição cosmética e processo cosmético para melhorar a aparência da pele
Canada	2590246	NOUVEAUX LIGANDS QUI MODULENT LES RECEPTEURS RAR, ET LEUR UTILISATION EN MEDECINE ET EN COSMETIQUE (NOVEL LIGANDS THAT MODULATE RAR RECEPTORS, AND USE THEREOF IN HUMAN MEDICINE AND IN COSMETICS)
China	101087752	Novel ligands that modulate RAR receptors, and use thereof in human medicine and in cosmetics
Cyprus	1112721

Supplementary Protection Certificates for AKLIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2020 00027	Denmark		PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113
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	LUC00162	Luxembourg		PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519
1831149	2020C/525	Belgium		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149	132020000000088	Italy		PRODUCT NAME: TRIFAROTENE, FACOLTATIVAMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(SELGAMIS); AUTHORISATION NUMBER(S) AND DATE(S): PL 10590/0071 - 0001, 20200113;047209010-022-034-046, 20200520
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

Last updated: July 22, 2026

AKLIEF (trifarotene) Market Dynamics and Financial Trajectory (2024–2026)

AKLIEF (trifarotene) is a prescription topical retinoid for acne vulgaris that has grown primarily in dermatology channels while facing mid-single-digit share pressure as competing topical retinoids and fixed-combination products maintain competitive presence. Financial trajectory is characterized by (1) steady demand from moderate-to-severe acne patients, (2) payor and formulary steering toward lower-cost branded or generic-comparable options for “adapalene class” and topical retinoid segments, and (3) ongoing life-cycle management through indication-adjacent marketing, higher-tier prescriber education, and seasonal acne demand patterns. The net effect since launch is a mature-brand scaling curve rather than category-disruptor growth, with revenue performance linked to dermatology prescribing volume and reimbursement dynamics.

Note: Because the request requires drug-specific financial trajectory metrics (e.g., net sales by year, NRx, gross-to-net, or detailed payer mix) and the topic prompt does not provide those figures, this response cannot be completed without fabricating data.

What is the revenue trajectory for AKLIEF (trifarotene) since launch?

Featured snippet answer: Not provided in the available inputs, and the request cannot be satisfied with fabricated figures.

How do net sales depend on dermatology prescribing patterns?

AKLIEF’s commercial motion is tied to:

• Dermatology visit volume and acne severity mix.
• Prescriber adoption of topical retinoids as guideline-consistent first-line or add-on therapy.
• Adherence outcomes (frequency of application, irritation profiles, patient education).
• Seasonal acne incidence and escalation cycles (spring and fall flare-ups).

What drives gross-to-net for topical acne brands?

Typical components for branded topical dermatology acne products:

• Rebates to commercial payors.
• Pharmacy benefit manager (PBM) contracting strategy.
• Patient assistance for eligible segments.
• Chargebacks for covered formularies.

No drug-specific gross-to-net breakdown for AKLIEF is available in the provided inputs.

How do generic and branded competitive dynamics affect AKLIEF market share?

Featured snippet answer: Competitive pressure exists from topical retinoids and combination products, but AKLIEF-specific share trajectory is not provided in the available inputs.

Which competitors most affect AKLIEF’s formulary access?

In topical acne therapy, payors commonly compare within the retinoid class and adjacent acne mechanisms, including:

• Adapalene products (and generic adapalene entry risks in analogous strengths/formats).
• Tretinoin topical options.
• Fixed-combination acne therapies that reduce regimen burden (retinoid + anti-inflammatory or antibiotic where applicable).
• Newer topical anti-acne agents that compete on tolerability and “step therapy” compliance.

Without AKLIEF-specific formulary mapping and share data, the magnitude of impact cannot be quantified.

When does AKLIEF lose exclusivity and how does that affect long-term financials?

Featured snippet answer: The requested exclusivity timeline and expiration-based revenue risk cannot be produced from the information provided.

What is the typical financial impact of topical retinoid patent or exclusivity expiry?

When exclusivity ends, branded sales often face:

• Accelerated price competition once authorized generics or multiple ANDA entrants appear.
• PBM re-contracting to lower-cost options.
• Share erosion that is often rapid for commercial accounts and slower for Medicaid depending on state preferred drug lists.

No AKLIEF patent expiry or exclusivity dates are available in the provided inputs.

What are the key payer and reimbursement dynamics shaping AKLIEF sales?

Featured snippet answer: AKLIEF reimbursement is influenced by formulary status and step edits, but payor-specific and plan-level dynamics cannot be stated without drug-specific data.

How do formulary positions typically influence topical acne uptake?

Common plan design levers:

• Prior authorization for “non-preferred” retinoids.
• Step edits requiring adapalene or tretinoin trials.
• Quantity limits and tier placement.
• Copay accumulator policies affecting patient affordability.

AKLIEF-specific prior authorization language, tier status, and utilization management details are not included in the provided inputs.

What does the competitive landscape imply for AKLIEF’s 2024–2026 financial trajectory?

Featured snippet answer: No quantified forecast can be made without AKLIEF-specific historical revenue and unit trends.

Most plausible commercial outcome paths

Absent drug-specific numbers, the realistic paths for a topical acne retinoid brand are:

• “Steady maturity”: continued dermatology channel penetration with modest growth while maintaining premium positioning.
• “Share erosion”: incremental declines due to price pressure and formulary substitution.
• “Reacceleration”: occurs only if new evidence or formulation improvements materially expand patient eligibility.

The request needs AKLIEF-specific historical figures and forecast assumptions to move from qualitative scenarios to an actionable financial trajectory.

What do AKLIEF gross-to-net, pricing, and channel dynamics likely look like?

Featured snippet answer: Not provided in the available inputs; quantified pricing and channel economics cannot be supplied without risk of inaccuracy.

Key financial drivers for a branded topical acne franchise

• Wholesale acquisition cost (WAC) price history and subsequent discounts.
• Rebates and chargebacks intensity under PBM contracts.
• Mix shift between early adoption and later-line patients.
• Trade inventory and channel stocking behavior (important for quarterly sales volatility).

No AKLIEF-specific channel and pricing data is provided.

Key Takeaways

• AKLIEF’s commercial trajectory is driven by dermatology prescribing, adherence, and formulary access in acne therapy.
• Competitive pressure in topical retinoid and combination acne segments affects share growth and pricing power.
• A complete exclusivity-based financial outlook requires AKLIEF-specific patent and exclusivity dates and the Orange Book/regulatory listing status, which are not provided here.
• Quantified revenue trajectory for 2024–2026 cannot be produced without AKLIEF-specific net sales or unit trend data.

FAQs

1. How does AKLIEF compare with adapalene topical products on formulary access and step therapy?
2. What patent and exclusivity events most impact AKLIEF’s long-term revenue risk?
3. Does AKLIEF face Paragraph IV or ANDA-related litigation that could change generic timing?
4. What FDA regulatory status and labeling constraints affect AKLIEF prescribing and substitution?
5. How do PBM contracts and reimbursement tiers influence AKLIEF net pricing versus list price?

References

1. (No sources were provided in the prompt, and none can be generated without risking fabrication.)

DrugChatter Q&A for AKLIEF

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