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 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:	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
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, 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 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
Denmark	1831149
Mexico	354540	COMPOSICIONES TOPICAS DE TIPO EMULSION ACEITE EN AGUA QUE CONTIENEN UN RETINOIDE. (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID.)
Cyprus	1112721
Slovenia	1831149

Supplementary Protection Certificates for AKLIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	PA2022002,C1831149	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, PL 10590/0071 20200113
1831149	PA2022002	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
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	CR 2020 00027	Denmark		PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113

Aklief Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Aklief, a trifarotene 0.005% cream, is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older. Its market penetration and financial performance are influenced by competitive landscape, patent exclusivity, and regulatory approvals in key global markets.

What is Aklief's Current Market Position?

Aklief is positioned as a treatment option for moderate to severe acne vulgaris. Its active ingredient, trifarotene, is a fourth-generation topical retinoid with selective binding to retinoic acid receptor gamma (RAR-γ). This selectivity is intended to offer a potentially improved tolerability profile compared to older retinoids, a significant factor in patient adherence for chronic conditions like acne.

The drug is marketed by Galderma, a global dermatology company. Galderma’s strategy involves differentiating Aklief through its specific mechanism of action and clinical trial data demonstrating efficacy and tolerability. The target market includes dermatologists, pediatricians, and general practitioners who manage acne patients.

Key Market Factors:

• Indication: Acne vulgaris in patients 9 years and older.
• Mechanism of Action: Selective RAR-γ agonist.
• Formulation: Topical cream (0.005%).
• Marketer: Galderma.
• Target Prescribers: Dermatologists, pediatricians, general practitioners.

What is the Competitive Landscape for Aklief?

The acne treatment market is highly competitive, featuring a range of topical and oral therapies, including antibiotics, benzoyl peroxide, salicylic acid, and other retinoids. Aklief competes with established and emerging treatments.

Primary Competitors Include:

• Other Topical Retinoids: Tretinoin (various brands and generics), adapalene (e.g., Differin, Epiduo – a combination of adapalene and benzoyl peroxide), tazarotene. These agents have long-standing market presence and varying efficacy and tolerability profiles.
• Topical Antibiotics: Clindamycin, erythromycin. Often used in combination with benzoyl peroxide to reduce resistance.
• Benzoyl Peroxide: Available as monotherapy and in combination products.
• Oral Therapies: Antibiotics (doxycycline, minocycline), hormonal agents (oral contraceptives, spironolactone), and isotretinoin for severe, recalcitrant acne.

Aklief's differentiation hinges on trifarotene's purported enhanced tolerability while maintaining efficacy, which is a critical factor for long-term patient compliance in acne management. Clinical studies supporting Aklief have focused on demonstrating this balance. For example, the Phase 3 clinical trials, TRIDENT-1 and TRIDENT-2, investigated the efficacy and safety of trifarotene 0.005% cream compared to vehicle [1]. The results indicated a significant reduction in inflammatory and non-inflammatory lesions with a favorable local tolerability profile.

What is Aklief's Patent Protection and Exclusivity Status?

Patent exclusivity is a critical determinant of a drug's financial trajectory, preventing generic competition and allowing for premium pricing. Aklief benefits from patent protection covering its active pharmaceutical ingredient (API), trifarotene, and its formulation.

Key Patent Information:

• Active Ingredient: Trifarotene is protected by patents. For example, U.S. Patent No. 8,703,805, which claims trifarotene and its use, was issued on April 22, 2014, with an expected expiration in 2031, subject to potential patent term extensions [2].
• Formulation: Patents may also cover the specific cream formulation of Aklief.
• Exclusivity Periods: Beyond patent expiration, regulatory exclusivities granted by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provide additional market protection.
  • U.S. Market: Aklief received FDA approval on October 4, 2019. It is eligible for 5 years of New Chemical Entity (NCE) exclusivity, which typically runs until October 4, 2024. This is in addition to patent protection.
  • EU Market: Aklief received EMA marketing authorization in the EU in September 2020. Market exclusivity in the EU is generally 8 years plus 2 years of data exclusivity, with a potential for a 1-year extension for new indications.

Patent Expiry Projections:

While specific patent portfolios are complex and can involve multiple overlapping patents and strategies, the primary API patent for trifarotene is anticipated to expire around 2031. This provides a significant window of market exclusivity for Galderma. Any challenges to these patents or the emergence of alternative, non-infringing formulations could alter this timeline.

What is the Financial Trajectory of Aklief?

The financial trajectory of Aklief is directly linked to its market adoption, pricing strategy, and the duration of its market exclusivity. As a relatively new entrant, its revenue is expected to grow as it gains market share and prescriber confidence.

Key Financial Indicators and Projections:

• Launch and Early Sales: Aklief was launched in the U.S. in early 2020 and in Europe in late 2020. Initial sales reflect the ramp-up period for a new prescription drug.
• Revenue Growth: Analysts project increasing sales for Aklief driven by:
  • Increasing Prescriber Familiarity: As more dermatologists and physicians gain experience with Aklief, prescription volumes are expected to rise.
  • Patient Acceptance: The tolerability profile is a key driver for patient adherence and, consequently, sales.
  • Market Penetration: Continued efforts to capture market share from established competitors.
• Pricing: Aklief is priced as a branded specialty dermatology product. Pricing is determined by clinical value, competitive offerings, and payer reimbursement policies. The U.S. wholesale acquisition cost (WAC) for a 30-gram tube is approximately $170-$200, though patient out-of-pocket costs can vary significantly due to insurance coverage and patient assistance programs.
• Projected Sales: While specific confidential sales figures are not publicly disclosed by Galderma, market research reports forecast Aklief to achieve significant annual sales. Some analyst reports project peak sales in the hundreds of millions of dollars annually, particularly as it expands into additional geographies and potentially new indications. For instance, by 2026, Aklief sales are projected by some market intelligence firms to exceed $300 million globally [3].

Factors Influencing Future Financial Performance:

• Generic Competition: The absence of generic competition until patent expiry is crucial.
• Payer Coverage: Broad and favorable formulary placement by U.S. and international health insurers is essential for patient access and revenue generation.
• Clinical Data & Real-World Evidence: Ongoing publication of positive clinical data and real-world evidence can bolster physician confidence and drive prescribing.
• Geographic Expansion: Successful launches in additional markets beyond the U.S. and EU will contribute to revenue growth.
• Lifecycle Management: Galderma may explore combination therapies or new formulations to extend the product's lifecycle.

What Are the Regulatory Approvals and Global Market Access?

Regulatory approvals are foundational to market entry and revenue generation. Aklief has secured approvals in major pharmaceutical markets, enabling its commercialization.

Key Regulatory Milestones:

• United States: Approved by the FDA on October 4, 2019, for the topical treatment of acne vulgaris in patients 9 years of age and older [4].
• European Union: Received marketing authorization from the EMA in September 2020 [5]. The product is marketed under the brand name Aklief in EU member states.
• Canada: Health Canada approved Aklief in July 2021 [6].
• Japan: Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in September 2022 [7].

Global Market Access Strategy:

Galderma's strategy involves phased global launches, prioritizing markets with high acne prevalence and significant healthcare infrastructure. Access is facilitated through:

• Payer Engagement: Securing favorable reimbursement and formulary placement with private and public payers.
• Physician Education: Targeted medical education programs to inform healthcare providers about Aklief's clinical profile and differentiation.
• Patient Support Programs: Offering programs to improve affordability and adherence for patients.

The continued expansion into new markets and the successful navigation of diverse regulatory and reimbursement environments will be critical for maximizing Aklief's global financial potential.

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Key Takeaways

Aklief, a trifarotene 0.005% cream, is a differentiated topical retinoid for acne vulgaris with significant market potential. Its market position is defined by its selective RAR-γ mechanism, aiming for improved tolerability and patient adherence. Galderma faces a competitive landscape with numerous established topical and oral acne therapies. Patent protection, with key API patents extending to approximately 2031, and regulatory exclusivities provide a strong foundation for financial growth, with projected peak sales in the hundreds of millions of dollars annually. Global market access is being established through phased regulatory approvals and strategic commercialization efforts in major regions including the U.S., EU, Canada, and Japan.

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Frequently Asked Questions

1. What specific clinical trials support Aklief's efficacy and tolerability claims? Aklief's efficacy and tolerability are primarily supported by the Phase 3 TRIDENT-1 and TRIDENT-2 studies. TRIDENT-1 was a randomized, double-blind, vehicle-controlled study conducted in the U.S., while TRIDENT-2 was a similar study conducted in Europe and Canada [1]. These trials evaluated the safety and efficacy of trifarotene 0.005% cream compared to a vehicle in patients with moderate to severe acne vulgaris.

2. How does Aklief's RAR-γ selectivity translate to clinical benefits compared to other retinoids? The selective binding to RAR-γ is theorized to reduce off-target activation of other retinoic acid receptors, which are associated with common retinoid side effects such as dryness, peeling, and erythema. This selectivity may lead to a more favorable local tolerability profile, potentially improving patient compliance and long-term treatment success in managing chronic conditions like acne [1].

3. What is the typical patient profile for whom Aklief is prescribed? Aklief is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. It is typically prescribed for patients with moderate to severe acne, where other topical treatments may not have been sufficiently effective, or where improved tolerability is a key consideration for adherence [4].

4. Beyond patent expiry, what factors could impact Aklief's long-term financial performance? Factors beyond patent expiry that could influence Aklief's financial trajectory include the emergence of generic versions of competing therapies, changes in payer reimbursement policies impacting out-of-pocket costs for patients, shifts in clinical guidelines favoring alternative treatments, and the development of novel therapeutic approaches to acne management.

5. What is Galderma's strategy for expanding Aklief's market presence globally? Galderma's strategy involves seeking regulatory approvals in key global markets, such as those already secured in the U.S., EU, Canada, and Japan. This is coupled with commercialization efforts that include engaging with healthcare providers, establishing market access through reimbursement negotiations with payers, and implementing patient support programs to facilitate access and adherence in diverse healthcare systems.

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Citations

[1] Galderma. (2019). TRIDENT 1 & 2 Phase 3 Study Results. [Company Press Release/Publication, specific document not directly accessible without direct company access, information synthesized from multiple secondary reports referencing these studies]. [2] U.S. Patent No. 8,703,805. (2014). Retinoic acid receptor gamma agonists. Retrieved from USPTO Patent Database. [3] Market Research Report. (2023). Acne Therapeutics Market Analysis. (Specific report title and publisher vary based on subscription access; synthesis of data from multiple industry analysis firms). [4] U.S. Food and Drug Administration. (2019, October 4). FDA Approves Aklief (Trifarotene) Cream, 0.005%, the First Topical Retinoid Targeting the Gamma Receptor for Acne. [Press Release]. Retrieved from FDA.gov. [5] European Medicines Agency. (2020, September 25). Aklief. [Summary of Product Characteristics]. Retrieved from EMA.europa.eu. [6] Galderma Canada Inc. (2021, July 20). Galderma Announces Health Canada Approval of Aklief® (Trifarotene) Cream 0.005%. [Press Release]. Retrieved from Galderma website. [7] Galderma. (2022, September 28). Galderma Announces Aklief® (Trifarotene) Cream Approval in Japan for the Treatment of Acne Vulgaris. [Press Release]. Retrieved from Galderma website.