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AKLIEF Drug Patent Profile

Which patents cover Aklief, and what generic alternatives are available?

Aklief is a drug marketed by Galderma Labs Lp and is included in one NDA. There are five 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 May 30, 2033. 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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	4
Patent Applications:	30
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

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
Taro Pharmaceuticals USA	Phase 1
Teva Pharmaceuticals, Inc.	Phase 3
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 five US patents and one FDA Regulatory Exclusivity.

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
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

International Patents for AKLIEF

When does loss-of-exclusivity occur for AKLIEF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

European Patent Office

France

Hong Kong

Israel

Japan

Mexico

New Zealand

Russian Federation

Singapore

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013269583	Oil/water-emulsion-type topical compositions containing a retinoid
South Korea	20070087626	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

Supplementary Protection Certificates for AKLIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	2020C/525	Belgium		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149	C01831149/01	Switzerland		PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020
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

AKLIEF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AKLIEF (Trifarotene) Cream

Introduction to AKLIEF

AKLIEF (trifarotene) Cream, 0.005%, is a groundbreaking topical treatment for acne, approved by the U.S. Food and Drug Administration (FDA) in October 2019. Developed by Galderma, a global leader in skin health, AKLIEF is the first new retinoid molecule for acne treatment in over 20 years[1].

Market Need and Positioning

The global acne market is substantial, with approximately 624 million prevalent cases in 2017, projected to increase to 683 million by 2026[4]. AKLIEF fills a critical gap in this market by offering a highly targeted retinoid that selectively targets the retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. This specificity makes AKLIEF unique in treating both facial and truncal acne, including areas such as the forehead, cheeks, nose, chin, chest, back, and shoulders[1].

Clinical Efficacy

The FDA approval of AKLIEF Cream was supported by data from two pivotal Phase 3 clinical trials involving 2,420 patients with moderate acne. These trials demonstrated that AKLIEF Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders, and chest compared to the vehicle. The treatment was well-tolerated, with common adverse reactions including application site irritation, itching, and sunburn[1].

Market Performance

Since its approval, AKLIEF has contributed to Galderma's strong financial performance. In the Therapeutic Dermatology segment, which includes AKLIEF, Galderma reported an 8.7% year-on-year net sales growth on a constant currency basis in 2023. This growth was driven by successful yield improvement measures in the U.S. and continued growth in international markets[2].

Financial Trajectory

Galderma's overall financial trajectory has been robust, with the company achieving record net sales of over $4 billion in 2023, an 8.5% increase year-on-year on a constant currency basis. The Therapeutic Dermatology segment, which includes AKLIEF, played a significant role in this growth. The segment's performance was bolstered by the success of key brands such as Differin, Soolantra, and AKLIEF[2].

Net Sales Growth

• In 2023, Galderma's net sales in the Therapeutic Dermatology segment grew by 8.7% on a constant currency basis, driven by the strong performance of AKLIEF and other key brands[2].
• The company's overall net sales growth was driven by volume growth across all product categories and a positive product mix impact, particularly in Injectable Aesthetics and Dermatological Skincare[2].

Core EBITDA Margin

• Galderma's Core EBITDA margin expanded significantly in 2023, reaching 23.1% with a 21.4% year-on-year growth on a constant currency basis. This expansion was driven by gains from premiumization, structural cost savings, and operating expenses leverage[2].

Geographical Performance

• Internationally, Galderma saw strong growth momentum in fast-growing markets such as China, India, Brazil, the UK, and Mexico. In the U.S., despite a high comparative base in the first half of 2023, the company still achieved double-digit growth in the second half[2].

Commercial Execution and Access

Galderma has been working closely with payers, providers, and pharmacy benefit managers to ensure broad and rapid access to AKLIEF Cream. The company also offers a patient savings card program, Galderma CareConnect, to make the treatment more accessible to patients[1].

Future Outlook

Galderma expects to continue its strong growth trajectory in 2024, with projected net sales growth of 7-10% on a constant currency basis. Despite increased investments in new products like nemolizumab, the company anticipates maintaining its Core EBITDA margin in line with 2023 levels[2].

Key Takeaways

• Innovative Treatment: AKLIEF is the first new retinoid molecule for acne treatment in over 20 years, targeting RAR gamma.
• Clinical Efficacy: Significant reduction in inflammatory lesions on the face and trunk.
• Market Performance: Contributed to Galderma's 8.7% year-on-year growth in Therapeutic Dermatology.
• Financial Trajectory: Part of Galderma's record net sales of over $4 billion in 2023.
• Access and Affordability: Supported by patient savings card programs and strong commercial execution.

FAQs

Q: What is AKLIEF Cream used for?

AKLIEF Cream is used for the topical treatment of acne, specifically targeting both facial and truncal acne.

Q: How does AKLIEF Cream work?

AKLIEF Cream selectively targets the retinoic acid receptor (RAR) gamma, the most common RAR found in the skin, to reduce inflammatory lesions.

Q: What were the results of the clinical trials for AKLIEF Cream?

The clinical trials showed significant reduction in inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders, and chest compared to the vehicle.

Q: How has AKLIEF Cream contributed to Galderma's financial performance?

AKLIEF has been a key contributor to Galderma's strong growth in the Therapeutic Dermatology segment, helping achieve an 8.7% year-on-year net sales growth.

Q: What are the common adverse reactions associated with AKLIEF Cream?

Common adverse reactions include application site irritation, itching, and sunburn.

Sources

1. Galderma Receives FDA Approval for AKLIEF® (trifarotene) Cream, 0.005% - PR Newswire
2. Galderma announces record 2023 net sales of over 4 B USD and significant core EBITDA margin expansion - Galderma
3. Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023 - Galderma
4. Global Acne Market Analysis, 2014-2026: Key Pipeline & Marketed Drugs - ResearchAndMarkets.com