DIFFERIN Drug Patent Profile

Which patents cover Differin, and when can generic versions of Differin launch?

Differin is a drug marketed by Galderma Labs Lp and is included in five NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in twenty-two countries.

The generic ingredient in DIFFERIN is adapalene. There are twelve drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the adapalene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Differin

A generic version of DIFFERIN was approved as adapalene by P AND L on June 2^nd, 2010.

Summary for DIFFERIN

International Patents:	56
US Patents:	4
Applicants:	1
NDAs:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	22
Patent Applications:	4,506
Drug Prices:	Drug price information for DIFFERIN
Drug Sales Revenues:	Drug sales revenues for DIFFERIN
What excipients (inactive ingredients) are in DIFFERIN?	DIFFERIN excipients list
DailyMed Link:	DIFFERIN at DailyMed

See drug prices for DIFFERIN

See drug sales revenues for DIFFERIN

Recent Clinical Trials for DIFFERIN

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

Sponsor	Phase
Bausch Health Americas, Inc.	Early Phase 1
Wake Forest University Health Sciences	Early Phase 1
Aurobindo Pharma Ltd	Phase 3

See all DIFFERIN clinical trials

Pharmacology for DIFFERIN

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for DIFFERIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIFFERIN	Topical Gel	adapalene	0.30%	021753	1	2009-09-15

US Patents and Regulatory Information for DIFFERIN

DIFFERIN is protected by four US patents.

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	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996		DISCN	Yes	No
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	020380-002	Jul 8, 2016		OTC	Yes	Yes
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	AB	RX	Yes	Yes
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		DISCN	Yes	No			Y

Expired US Patents for DIFFERIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007

International Patents for DIFFERIN

See the table below for patents covering DIFFERIN around the world.

Country	Patent Number	Title	Estimated Expiration
France	2890861	COMPOSITIONS COMPRENANT AU MOINS UN DERIVE DE L'ACIDE NAPHTOIQUE ET AU MOINS UN COMPOSE DE TYPE POLYMERES DE POLYURETHANES OU DES DERIVES DE CELUI-CI, LEURS PROCEDE DE PREPARATION, ET LEUR UTILISATION (Composition, useful to treat and/or prevent e.g. dermatological diseases, acne necrotic, acne neonatorum, comprises naphthoic acid derivative and polyurethane type polymer)
Portugal	82361	PROCESSO PARA A PREPARACAO DE DERIVADOS BENZONAFTALENICOS E SUA UTILIZACAO NOS DOMINIOS FARMACEUTICOS E COSMETICO
Spain	2319778
World Intellectual Property Organization (WIPO)	03075908

Supplementary Protection Certificates for DIFFERIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	08C0024	France		PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369	132008901685368	Italy		PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
0199636	300209	Netherlands		300209, 20060411, EXPIRES: 20070702
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111

Market Dynamics and Financial Trajectory for Differin

Introduction to Differin

Differin, a brand name for the active ingredient adapalene, is a topical retinoid used primarily for the treatment of acne. It is manufactured by Galderma Laboratories and has been a significant player in the dermatological skincare market.

Market Growth Drivers

Regulatory Approvals

The global adapalene products market, including Differin, has seen significant growth due to regulatory approvals. For instance, in 2016, the U.S. Food and Drug Administration (FDA) approved Differin gel 0.1% for over-the-counter (OTC) treatment of acne for patients 12 years and older. This approval has expanded the market reach and accessibility of the product[1].

Rising Prevalence of Acne

The increasing prevalence of skin-related problems, particularly acne, is a major driver of the market. According to the National Center for Biotechnology Information (NCBI), approximately 15 to 30 teenagers out of 100 suffer from moderate to severe acne, with a higher incidence in females compared to males. This rising demand for effective acne treatments fuels the growth of adapalene products[1].

Cost-Effectiveness

The availability of generic adapalene at a lower cost compared to branded versions is another factor driving market growth. For example, a 45g tube of generic adapalene 0.1% gel costs around $150, significantly less than the branded Differin gel 0.1%, which costs around $300[1].

Market Restraints

Side Effects

Despite its effectiveness, adapalene products like Differin face market restraints due to associated side effects such as skin discoloration, red skin, contact dermatitis, and intense burning sensations. These side effects can deter some potential users and hamper market growth[1].

Alternative Treatments

The availability of alternative acne treatments, such as Ziana Gel (Clindamycin Phosphate), also poses a challenge to the market growth of adapalene products. Consumers may opt for these alternatives based on personal preferences or dermatological recommendations[1].

Regional Market Analysis

Global Performance

Galderma, the manufacturer of Differin, has reported strong global performance. In the first half of 2024, Galderma achieved record net sales of $2.2 billion, with a year-on-year growth of 10.8% on a constant currency basis. This growth is driven by volume increases and favorable product mix across various geographies, including significant growth in International markets such as China[3].

Dermatological Skincare Segment

The Dermatological Skincare segment, which includes Differin, saw a year-on-year growth of 11.8% on a constant currency basis in the first half of 2024. This segment's performance is a key contributor to Galderma's overall growth[3].

Financial Performance

Galderma's Financials

Galderma's financial performance indicates strong profitability. For the first half of 2024, the company reported Core EBITDA of $514 million, representing a 23.4% margin, which is an increase of 30 basis points compared to the full year 2023. This growth is attributed to sales increases and operating leverage[3].

Debt and Leverage

Galderma has also made significant strides in managing its debt, reducing leverage to 2.6x by the end of June 2024 and repaying $100 million of debt early. This financial discipline is expected to reduce interest cash expenses in the second half of 2024[3].

Market Trends and Outlook

Acne Treatment Market

The global acne treatment market, within which Differin operates, is projected to grow from $11.62 billion in 2024 to $17.48 billion by 2032, at a CAGR of 5.2%. This growth is driven by the rising prevalence of acne and the launch of advanced drugs[4].

Geographical Growth

Asia Pacific is expected to register the highest CAGR in the acne treatment market due to increasing awareness and the entry of more companies into the region. Latin America and the Middle East & Africa will also see significant growth, albeit at a slower pace[4].

Competitive Landscape

Key Players

Galderma, along with other major players like Allergan and Bausch Health Companies Inc., dominates the global acne treatment market. These companies are continuously innovating and expanding their product portfolios to maintain market share[4].

Key Takeaways

• Regulatory Approvals: FDA approvals have significantly expanded the market reach of Differin.
• Rising Acne Prevalence: Increasing cases of acne drive demand for effective treatments like Differin.
• Cost-Effectiveness: Generic versions of adapalene offer a cost-effective alternative.
• Side Effects: Associated side effects can hamper market growth.
• Alternative Treatments: Availability of alternative treatments poses a competitive challenge.
• Strong Financial Performance: Galderma’s financials indicate robust growth and profitability.
• Market Trends: The acne treatment market is expected to grow at a CAGR of 5.2% from 2024 to 2032.

Frequently Asked Questions (FAQs)

Q: What is Differin used for? A: Differin is used for the treatment of acne, particularly for patients 12 years and older.

Q: What are the common side effects of Differin? A: Common side effects include skin discoloration, red skin, contact dermatitis, and intense burning sensations.

Q: Is Differin available over-the-counter (OTC)? A: Yes, Differin gel 0.1% was approved by the FDA for OTC use in 2016.

Q: How does the cost of Differin compare to generic adapalene? A: Generic adapalene 0.1% gel is significantly cheaper than the branded Differin gel 0.1%, with a 45g tube costing around $150 compared to $300 for the branded version.

Q: What is the projected growth of the global acne treatment market? A: The global acne treatment market is projected to grow from $11.62 billion in 2024 to $17.48 billion by 2032, at a CAGR of 5.2%.

Sources:

1. Coherent Market Insights - Adapalene Products Market - Share, Size and Industry Analysis
2. PR Newswire - DFIN Reports Fourth-Quarter and Full-Year 2023 Results
3. Galderma - Galderma delivers record net sales of 2.2 billion USD and 10.8% year-on-year growth on a constant currency basis
4. Fortune Business Insights - Acne Treatment Market Size, Trends | Revenue Share [2032]