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:	10
Patent Applications:	89
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
Taro Pharmaceuticals USA	Phase 1
Teva Pharmaceuticals USA	Phase 3
Teva Pharmaceuticals, Inc.	Phase 3

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	9,498,465		Y
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	8,470,871
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

International Patents for trifarotene

Country	Patent Number	Title	Estimated Expiration
Israel	236001	תכשירים מסוג אמולסיית שמן/מים למתן מקומי הכוללים רטינואיד (Oil/water-emulsion-type topical compositions containing a retinoid)
European Patent Office	2854803	COMPOSITIONS TOPIQUES SOUS FORME DE GEL CONTENANT UN RÉTINOÏDE PARTICULIER SOLUBILISÉ (TOPICAL GEL COMPOSITION COMPRISING A SOLUBILIZED SPECIFIC RETINOID)
Japan	2015523342	レチノイドを含有する油／水エマルション型局所的組成物
European Patent Office	1831149	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)
Australia	2013269582	Topical compositions in the form of a gel containing a particular solubilised retinoid

Supplementary Protection Certificates for trifarotene

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	719	Finland
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,C1831149	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, PL 10590/0071 20200113
1831149	2020C/525	Belgium		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224

Trifarotene Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Trifarotene

Introduction to Trifarotene

Trifarotene, a 4th generation topical retinoid, was approved by the FDA in 2019 for the treatment of acne in patients over 9 years of age. This innovative drug has opened new avenues in the treatment of acne vulgaris, particularly for facial and truncal acne[1][2][5].

Market Need and Demand

Acne vulgaris is a chronic inflammatory skin disease with a high incidence in the population, significantly impacting patients' quality of life. The demand for effective and safe treatments is constant, and trifarotene fills this gap by offering a selective mechanism of action on RAR-γ receptors, which distinguishes it from earlier generations of retinoids[1].

Clinical Efficacy and Safety

Trifarotene has demonstrated high efficacy in clinical trials, such as the PERFECT 1 and PERFECT 2 studies, which involved over 2,400 patients. These studies showed significant improvements in acne lesions, with treatment success rates of 65.1% for facial acne and 66.9% for truncal acne. The drug also showed a favorable safety profile, with common adverse effects being mild and including pruritus, irritation, and sunburn[2][5].

Unique Selling Points

• Selective Mechanism of Action: Trifarotene's specificity to RAR-γ receptors reduces the side effects commonly associated with other retinoids, such as flaking, erythema, and swelling[1][5].
• Ease of Application: The formulation of trifarotene makes it easy to apply on large areas like the chest and back, which is a significant advantage for patients with truncal acne[5].
• Comprehensive Treatment: Trifarotene not only reduces acne lesions but also improves post-inflammatory hyperpigmentation (PIH), making it a holistic treatment option[4].

Market Reception

Since its approval, trifarotene has been well-received by both physicians and patients. It addresses a long-standing need for an effective and safe topical retinoid, especially for acne on the torso, an area often challenging to treat with traditional topical treatments[5].

Financial Trajectory

• Market Potential: Given its efficacy and safety profile, trifarotene has significant market potential. It is expected to capture a substantial share of the acne treatment market, particularly among patients seeking alternatives to existing treatments.
• Cost Considerations: While trifarotene is effective, its cost may be a prohibitive factor for some patients. However, the long-term benefits and the reduction in the need for multiple treatments could offset the initial cost[2].
• Revenue Projections: With its approval and positive clinical trial outcomes, trifarotene is likely to generate substantial revenue for its manufacturers. The drug's unique selling points and the growing demand for effective acne treatments will drive its financial trajectory.

Competitive Landscape

Trifarotene enters a market dominated by earlier generations of retinoids and other acne treatments. However, its selective mechanism of action and favorable safety profile position it as a competitive alternative. Future trials comparing its efficacy and tolerability with older retinoids will further solidify its place in the market[2].

Patient and Physician Adoption

• Patient Satisfaction: Studies have shown that patients using trifarotene experience significant improvements in their condition, leading to higher patient satisfaction rates. This positive feedback is crucial for market adoption[4].
• Physician Endorsement: The drug's efficacy and safety have been endorsed by physicians, who see it as a valuable addition to their therapeutic arsenal. This endorsement is key to widespread adoption in clinical practice[5].

Future Directions and Clinical Trials

Ongoing and future clinical trials will continue to evaluate the efficacy and safety of trifarotene, including its use in combination with oral antibiotics for severe acne. These studies will provide further evidence of its benefits and help in expanding its indications[5].

Regulatory and Approval Status

Trifarotene was granted FDA approval in 2019, and it has also been granted orphan drug status for treating lamellar ichthyosis. These regulatory approvals have paved the way for its commercialization and widespread use[1].

Global Market Impact

The global acne treatment market is expected to grow, and trifarotene is poised to be a significant player in this market. Its approval and adoption in various countries will contribute to its global market impact.

"Trifarotene is a newly Food and Drug Administration-labeled fourth-generation topical retinoid that shows particular promise in the treatment of facial and truncal acne vulgaris. It is an effective and safe addition to currently available retinoids."[2]

Key Takeaways

• Innovative Treatment: Trifarotene is a 4th generation topical retinoid with a selective mechanism of action on RAR-γ receptors.
• Clinical Efficacy: It has shown significant improvements in acne lesions and post-inflammatory hyperpigmentation.
• Safety Profile: Trifarotene has a favorable safety profile with mild adverse effects.
• Market Potential: It has significant market potential due to its unique selling points and growing demand.
• Financial Trajectory: Expected to generate substantial revenue, though cost may be a factor.
• Competitive Landscape: Positions itself as a competitive alternative to existing treatments.

FAQs

Q: What is trifarotene and how does it work? A: Trifarotene is a 4th generation topical retinoid that works by selectively targeting RAR-γ receptors, reducing acne lesions and post-inflammatory hyperpigmentation.

Q: Who is trifarotene approved for? A: Trifarotene is approved by the FDA for the treatment of acne in patients over 9 years of age.

Q: What are the common side effects of trifarotene? A: Common side effects include pruritus, irritation, and sunburn, which are generally mild.

Q: How effective is trifarotene in treating acne? A: Trifarotene has shown significant efficacy in clinical trials, with treatment success rates of 65.1% for facial acne and 66.9% for truncal acne.

Q: Is trifarotene expensive? A: While trifarotene may be more expensive than some existing treatments, its long-term benefits and reduced need for multiple treatments could offset the initial cost.

References

1. Trifarotene: a new chapter in the treatment of acne. An overview of ... - RJSVD.
2. Trifarotene for the Treatment of Facial and Truncal Acne - PubMed.
3. Target Date Funds and Stock Market Dynamics | NBER - (Not relevant to trifarotene).
4. Trifarotene Yields Significant Improvements in Post-Inflammatory ... - Dermatology Times.
5. A New Prospect in Retinoid Therapy: Trifarotene - Actas Dermo-Sifiliográficas.