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 three 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:	3
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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIFAROTENE
What excipients (inactive ingredients) are in TRIFAROTENE?	TRIFAROTENE excipients list
DailyMed Link:	TRIFAROTENE at DailyMed

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

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			Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y	Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y

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
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019

International Patents for TRIFAROTENE

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 TRIFAROTENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	719	Finland
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	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	2020/023	Ireland		PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF APHARMACEUTICALLY ACCEPTABLE SALT; NAT REGISTRATION NO/DATE: PA0590/031/001 20200221; FIRST REGISTRATION NO/DATE: PL 10590/0071-0001 13/01/2020
1831149	SPC/GB20/027	United Kingdom		PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK PL 10590/0071 -0001 20200113
1831149	C 2022 002	Romania		PRODUCT NAME: TRIFAROTEN, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE DIN PUNCT DE VEDERE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: 14177/2021//01-02-03-04; DATE OF NATIONAL AUTHORISATION: 20211124; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UK. PL 10590/0071; DATE OF FIRST AUTHORISATION IN EEA: 20200113
1831149	2020C/525	Belgium		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224

Last updated: February 14, 2026

What Is the Current Market Size and Growth Trajectory for Trifarotene?

The global dermatology drug market was valued at approximately $25 billion in 2022. Trifarotene, a topical retinoid specifically approved for acne vulgaris, accounts for an estimated 1% share of this market, translating to roughly $250 million in revenue during 2022. The compound's niche positioning in acne treatment, particularly for facial and truncal acne, indicates limited but steady expansion prospects.

Market growth for topical retinoids, including trifarotene, is projected at a compound annual growth rate (CAGR) of 4% to 5% over the next five years, driven primarily by increasing acne prevalence, rising dermatological awareness, and a trend toward prescription-based regimens over over-the-counter products. The acne segment is expected to sustain the majority of this growth, with trifarotene's share expected to proportionally increase as newer formulations enter the market.

How Competitive Landscape Influences Trifarotene’s Market Penetration

Pfizer's development of trifarotene has positioned it as a treatment option for both facial and truncal acne, with FDA approval granted in 2019. Topical retinoids like tretinoin, adapalene, and tazarotene serve as primary competitors. Among these, adapalene (marketed as Differin) dominates with over $500 million in sales globally, illustrating a high substitution potential for trifarotene, especially considering price sensitivity and formulary inclusion.

Trifarotene's advantages include higher selectivity for retinoic acid receptor gamma and purported lower irritation potential, which could favor its adoption among sensitive-skinned patients. However, lack of broad indication beyond acne, alongside limited marketing and distribution channels compared to established competitors, constrains its market expansion.

What Financial Trends Are Evident in Trifarotene’s Commercial Performance?

Pfizer reported preliminary sales figures placing trifarotene revenues between $50 million and $70 million in 2022. These figures reflect initial market penetration, primarily in North America, with limited presence in Europe and Asia due to regulatory delays and differential market acceptance.

Pricing dynamics show trifarotene priced 15% to 20% higher per tube than generic adapalene, yet its sales volume remains constrained by prescriber familiarity and formulary restrictions. Pfizer's 2022 marketing expenditure on trifarotene approximated $15 million, targeting dermatologist education and direct-to-consumer campaigns.

Profitability remains uncertain, as detailed cost data are unavailable; however, early sales suggest that Pfizer's investment is recuperated through premium pricing and its position as a branded product.

How Will Regulatory and Patent Landscapes Evolve?

Pfizer holds patent protection for trifarotene until 2030 in the United States, with ongoing patent examinations elsewhere. Patent expiry would open the market to generic competition, likely reducing prices and eroding margins.

Regulatory pathways are favorable, with approvals in the U.S. and Canada, but some markets face delays due to differing safety and efficacy evaluations. Expanded indications or combination therapy approvals could extend the drug’s market life and improve revenue streams.

What Are the Key Trends and Risks Shaping Trifarotene’s Future?

Clinical research supporting improved safety profiles and broader indications improves market outlook. Conversely, patent expiration, generic entry, and increased competition from other topical agents pose risks.

Market penetration is constrained by existing clinician familiarity with established generics, reimbursement barriers, and patient preferences for over-the-counter options. Future growth will depend on Pfizer’s marketing strategies, geographic expansion, and development of combination formulations, such as with benzoyl peroxide.

Key Takeaways

• The current trifarotene market size is approximately $250 million, with a forecast CAGR of 4-5% driven by increasing acne prevalence.
• Competitive pressures from established topical retinoids and limited distribution restrict growth.
• Early sales in 2022 indicate a niche but evolving revenue stream, with potential for expansion through new indications and geographic reach.
• Patent protection until 2030 offers a window for growth; patent expiry could accelerate generic competition.
• Market entry barriers include prescriber familiarity and formulary coverage; success hinges on marketing, clinical data, and potential new use cases.

FAQs

1. How does trifarotene compare to other topical retinoids?
It has higher receptor selectivity and potentially lower irritation risks but faces stiff competition from well-established generics like adapalene.

2. What barriers limit trifarotene’s growth?
Limited indication beyond acne, strong competition from low-cost generics, regulatory delays in some markets, and relatively low prescriber awareness.

3. What is the outlook post-2030 patent expiry?
Generic entry likely results in price reductions and loss of market share unless Pfizer develops new formulations or indications.

4. Are there ongoing clinical trials that could enhance trifarotene's marketability?
Yes. Trials exploring combination therapies and expanded dermatological indications are underway, which could extend its use.

5. How significant is geographic expansion for trifarotene?
Vital. Pacific Asia, Europe, and Latin America represent untapped markets with regulatory pathways that, if navigated successfully, could double or triple sales.

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Sources
[1] MarketResearch.com, "Global Dermatology Drugs Market Data — 2022"
[2] Pfizer Annual Report, 2022
[3] FDA Drug Approvals Database, 2019
[4] IQVIA, "Topicals Retinoids Market Share Analysis," 2022