TRIFAROTENE - Generic Drug Details

What are the generic drug sources for trifarotene and what is the scope of freedom to operate?

Trifarotene is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trifarotene has sixty patent family members in twenty-eight countries.

There is one drug master file entry for trifarotene. One supplier is listed for this compound.

Summary for TRIFAROTENE

International Patents:	60
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	12
What excipients (inactive ingredients) are in TRIFAROTENE?	TRIFAROTENE excipients list
DailyMed Link:	TRIFAROTENE at DailyMed

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

Constraining patent/regulatory exclusivity:

9,084,778

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 TRIFAROTENE

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

Sponsor	Phase
Galderma R&D	PHASE3
Sun Pharmaceutical Industries, Inc.	PHASE1
Taro Pharmaceuticals USA	Phase 1

See all TRIFAROTENE clinical trials

Pharmacology for TRIFAROTENE

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for TRIFAROTENE

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for TRIFAROTENE

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

US Patents and Regulatory Information for TRIFAROTENE

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

Expired US Patents for TRIFAROTENE

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 TRIFAROTENE

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
Singapore	11201408759X	OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID

Supplementary Protection Certificates for TRIFAROTENE

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
1831149	20C1025	France		PRODUCT NAME: TRIFAROTENE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: CIS 6 363 190 8 20200217; FIRST REGISTRATION: GB - PL 10590/0071 20200113

Market Dynamics and Financial Trajectory of Trifarotene

Last updated: July 28, 2025

Introduction

Trifarotene, a selective fourth-generation retinoid, has garnered significant attention within dermatological therapeutics since its approval by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of acne vulgaris. As a first-in-class RAR-γ selective retinoid, trifarotene offers targeted action with improved safety profiles, positioning itself as an attractive alternative amidst existing acne treatments. This detailed analysis explores the evolving market landscape and the projected financial trajectory for trifarotene, considering regulatory, clinical, competitive, and commercial factors influencing its growth potential.

Market Fundamentals and Therapeutic Outlook

Therapeutic Segment

Acne vulgaris remains one of the most prevalent skin conditions globally, with a market size estimated at $4.3 billion in 2022 and projected compound annual growth rate (CAGR) of approximately 5.2% through 2027 [1]. Topical retinoids are foundational in acne management, with tretinoin, adapalene, and tazarotene constituting significant market segments. Trifarotene distinguishes itself through selective RAR-γ targeting, which theoretically minimizes irritation and enhances tolerability—a critical determinant of patient adherence.

Market Drivers

• Unmet Need for Superior Tolerability: Acne patients often discontinue treatment due to side effects from existing retinoids. Trifarotene’s favorable safety profile positions it favorably among clinicians seeking effective yet well-tolerated options.
• Expanding Indications: While initially approved for acne vulgaris, ongoing clinical investigations may extend its use to other dermatological conditions, such as psoriasis and keratinization disorders.
• Growing Acne Incidence: Rising prevalence among adolescents and adults globally sustains demand. Urbanization, hormonal influences, and lifestyle factors continue to fuel market growth.

Regulatory and Commercial Milestones

Post-approval, strategic regulatory actions in key markets are pivotal:

• FDA Approvals: The regulatory endorsement in the U.S. provides a solid foundation, enabling targeted marketing strategies.
• European and Asian Markets: Approval in these regions depends on local regulatory processes; success here broadens revenue streams.
• Off-Label Expansion and Investigator-Led Trials: Positive clinical data can catalyze widened usage and newer indications.

Competitive Landscape

The acne topical segment faces intense competition:

• Established Players: Galderma’s Differin (adapalene) and Tazorac (tazarotene) dominate with entrenched prescriber habits.
• Innovator Differentiation: Trifarotene’s selectivity offers a potential differentiator—clinical data indicating reduced irritation may convert into increased market share.
• New Entrants: Emerging topical agents and combination therapies continually threaten market positioning.

Pricing and Reimbursement

Pricing strategies influence adoption:

• Premium Positioning: Trifarotene’s novel mechanism may warrant higher pricing, contingent on demonstrable clinical benefits.
• Reimbursement Policies: Coverage by payers depends on cost-effectiveness evidence, impacting product uptake.

Financial Projections and Revenue Models

Initial Launch Period (2020-2023)

• Sales Trajectory: Early adoption remains modest; initial sales estimated at approximately $40-$60 million globally in 2022.
• Market Penetration: Limited by existing preferences for generic retinoids and awareness levels.
• Investment in Awareness: Heavy marketing and educational campaigns are necessary to shift prescriber behavior.

Mid-Term Outlook (2024-2028)

• Growth Catalysts:
  • Broadened prescribing guidelines.
  • Increased clinical data confirming safety and efficacy.
  • Successful expansion into international markets.
• Forecasted Revenue: Potential to reach $150-$300 million annually globally by 2028, assuming a compounded annual growth rate of approximately 20-30%.

Long-Term Prospects (2029 and Beyond)

• Market Share Capture: As clinical confidence solidifies, trifarotene could command a notable fraction of topical acne prescriptions.
• Pipeline Development: Further formulations, combination products, or new indications could augment revenue streams.
• Patent and Exclusivity: Market exclusivity until approximately 2030 grants a window for sustained revenue growth.

Key Challenges and Risk Factors

• Market Penetration: Dominance of entrenched brands and generics constrains growth.
• Clinical Acceptance: Reliance on clinician familiarity and perceived benefit over existing agents.
• Regulatory Hurdles: Approval delays or rejections in international markets could impede expansion.
• Pricing Pressures: Payer negotiations may lead to price erosion over time.

Conclusion

Trifarotene’s market dynamics hinge on its unique pharmacological profile, safety advantages, and evolving clinical landscape. While initial sales are modest, strategic expansion, enhanced clinical data, and global regulatory approvals could propel its financial trajectory significantly over the next decade. Successful commercialization will depend on effective positioning against entrenched competitors and aligning reimbursement strategies to maximize market penetration.

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Key Takeaways

• Market Penetration Potential: Trifarotene’s targeted mechanism and safety profile position it well for growth amidst a saturated acne treatment market.
• Revenue Forecasts: Expected to reach $150–300 million globally by 2028, driven by expanding indications, international approvals, and clinician adoption.
• Competitive Edge: Its selectivity provides a key differentiator, but overcoming established brand loyalty remains critical.
• Strategic Imperatives: Continued clinical validation, targeted marketing efforts, and international regulatory progress are essential to realize its financial potential.
• Risk Management: Monitoring payer policies, patent status, and clinical acceptance will mitigate potential hurdles.

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FAQs

Q1: What distinguishes trifarotene from other topical retinoids?
A1: Trifarotene selectively targets retinoic acid receptor gamma (RAR-γ), primarily expressed in the skin, which may translate into fewer side effects and improved tolerability compared to earlier-generation retinoids like tretinoin or adapalene.

Q2: How has regulatory approval influenced trifarotene’s market prospects?
A2: FDA approval in 2019 provided a pivotal platform, facilitating entry into the U.S. market. Additional approvals in Europe and Asia could significantly expand its commercial footprint.

Q3: What are the main barriers to trifarotene’s market share growth?
A3: Established treatment preferences, generic competition, and limited clinician familiarity pose barriers. Payer coverage and pricing strategies further influence penetration.

Q4: What is the outlook for trifarotene’s use beyond acne vulgaris?
A4: Clinical trials investigating use in conditions like psoriasis and keratinization disorders may open new therapeutic avenues, potentially diversifying revenue streams.

Q5: How important are international markets for trifarotene’s revenue?
A5: Strategic expansion into key European and Asian markets is crucial, as these regions collectively hold substantial dermatological treatment shares and offer growth opportunities for innovative agents.

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Sources:
[1] Market Research Future. "Acne Treatment Market Analysis." 2022.