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Last Updated: December 22, 2024

DIFFERIN Drug Patent Profile


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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 five 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. Forty 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 2nd, 2010.

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Drug patent expirations by year for DIFFERIN
Drug Prices for DIFFERIN

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Drug Sales Revenue Trends for DIFFERIN

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Recent Clinical Trials for DIFFERIN

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

SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
Bausch Health Americas, Inc.Early Phase 1
Aurobindo Pharma LtdPhase 3

See all DIFFERIN clinical trials

Pharmacology for DIFFERIN
Drug ClassRetinoid
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 five 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 CREAM;TOPICAL 020748-001 May 26, 2000 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe ⤷  Subscribe
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Subscribe ⤷  Subscribe
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DIFFERIN

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03075908 ⤷  Subscribe
Japan 2012184258 COMPOSITION CONTAINING AT LEAST ONE DERIVATIVE OF NAPHTHOIC ACID AND AT LEAST ONE POLYURETHANE POLYMER TYPE COMPOUND OR DERIVATIVE THEREOF, PREPARATION METHOD, AND USE OF THE SAME ⤷  Subscribe
Russian Federation 2421216 КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПО МЕНЬШЕЙ МЕРЕ ОДНО ПРОИЗВОДНОЕ НАФТОЕВОЙ КИСЛОТЫ И ПО МЕНЬШЕЙ МЕРЕ ОДНО СОЕДИНЕНИЕ ТИПА ПОЛИУРЕТАНОВОГО ПОЛИМЕРА ИЛИ ЕГО ПРОИЗВОДНОЕ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ (COMPOSITIONS CONTAINING AT LEAST ONE NAPHTHOIC ACID DERIVATIVE AND AT LEAST ONE COMPOUND OF POLYURETHANE POLYMER OR ITS DERIVATIVE, METHODS OF PRODUCING AND APPLYING THEREOF) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIFFERIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 132008901685368 Italy ⤷  Subscribe 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 ⤷  Subscribe 300209, 20060411, EXPIRES: 20070702
1458369 SPC/GB10/005 United Kingdom ⤷  Subscribe PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

DIFFERIN Market Analysis and Financial Projection Experimental

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]

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