ABSORICA LD Drug Patent Profile

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

Absorica Ld is a drug marketed by Sun Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has seventeen patent family members in nine countries.

The generic ingredient in ABSORICA LD is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Absorica Ld

A generic version of ABSORICA LD was approved as isotretinoin by AMNEAL PHARMS NY on September 29^th, 2017.

Summary for ABSORICA LD

International Patents:	17
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	10
Patent Applications:	7,956
Drug Prices:	Drug price information for ABSORICA LD
DailyMed Link:	ABSORICA LD at DailyMed

See drug prices for ABSORICA LD

Recent Clinical Trials for ABSORICA LD

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

Sponsor	Phase
Children's Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 2
Sun Pharmaceutical Industries Limited	Phase 4

See all ABSORICA LD clinical trials

Pharmacology for ABSORICA LD

Drug Class

Retinoid

US Patents and Regulatory Information for ABSORICA LD

ABSORICA LD is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-001	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-004	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-002	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-006	Nov 5, 2019		RX	Yes	Yes			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-004	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-001	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-002	Nov 5, 2019		RX	Yes	No			Y

International Patents for ABSORICA LD

See the table below for patents covering ABSORICA LD around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3200877
Japan	2017521470	イソトレチノインの経口医薬組成物
Brazil	112017001963
South Africa	201700843	ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN
Canada	2963206
Japan	2017530149	低用量経口イソトレチノイン医薬組成物
Brazil	112017006779

Market Dynamics and Financial Trajectory for ABSORICA LD

Introduction

Absorica LD, a formulation of isotretinoin developed by Sun Pharma, is a significant player in the treatment of severe recalcitrant nodular acne. This article delves into the market dynamics and financial trajectory of ABSORICA LD, highlighting key milestones, market share, revenue growth, and the competitive landscape.

Market Overview of Isotretinoin

The isotretinoin market is characterized by intense competition and continuous innovation. Major players such as Roche, Dr. Reddy's Laboratories, Teva Pharmaceuticals, Sun Pharma, and Almirall are actively investing in research and development to enhance their product lines and address the severe side effects associated with isotretinoin use[3].

Launch and Market Position of ABSORICA LD

Absorica LD was introduced as a new formulation of the existing drug Absorica, aimed at increasing the bioavailability of isotretinoin and enabling a reduced dose. The drug is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years and older, with a recommended dosing regimen of 0.4 to 0.8 mg/kg/day in two divided doses for 15 to 20 weeks[4].

Market Share and Competitive Landscape

As of the second quarter of 2021, the market share of Absorica and its authorized generic version, including Sun Pharma's Absorica LD, was approximately 6.2% in the U.S. isotretinoin prescription market. This market share is significant, especially considering the competitive nature of the isotretinoin market[1].

Impact of Generic Competition

The entry of generic versions into the market poses a challenge to branded products like Absorica LD. Generic competition can lead to pricing pressures, reducing profit margins for both branded and generic manufacturers. However, strategic partnerships and innovative formulations, such as Absorica LD, help maintain market share and competitiveness[3].

Financial Performance of Cipher Pharmaceuticals

Cipher Pharmaceuticals, which has a licensing agreement with Sun Pharma for Absorica, has reported strong financial results driven partly by the performance of Absorica and its generic versions.

Revenue Growth

In the second quarter of 2021, Cipher Pharmaceuticals reported a 30% increase in total revenue to $6.1 million, compared to $4.7 million in the same period of 2020. Licensing revenue from Absorica in the U.S. was $2.4 million, an increase of 25% from the previous year[1].

Adjusted EBITDA and Net Income

Adjusted EBITDA for Cipher Pharmaceuticals increased by 40% to $4.1 million in Q2 2021, while net income from continuing operations rose to $2.8 million, or $0.11 per basic share, a 450% increase from the previous year[1].

Cash Flow and Balance Sheet

The company generated $7.6 million in cash from operating activities in the six months ending June 30, 2021, and ended the quarter with $16.1 million in cash and no debt[1].

Recent Trends and Challenges

Q1 2022 Financials

In the first quarter of 2022, licensing revenue from Absorica in the U.S. decreased by 39% to $1.4 million, primarily due to the absence of a full quarter of brand Absorica sales. However, the overall market share remained stable, with Absorica and its generic versions holding approximately 5.2% of the market, including Sun's Absorica LD[2].

Pricing Pressures and Generic Competition

The isotretinoin market is subject to significant pricing pressures due to generic competition. This can lead to reduced revenue and profit margins for manufacturers. However, strategic partnerships and the launch of new formulations like Absorica LD help mitigate these effects[3].

Strategic Initiatives and Outlook

Partnership with Sun Pharma

The partnership between Cipher Pharmaceuticals and Sun Pharma has been instrumental in driving growth. According to Craig Mull, Interim CEO of Cipher, "We are confident that working with Sun Pharma is the right economic decision for Cipher and is consistent with our overall strategy to maximize the value of the isotretinoin portfolio"[1].

Market Expansion and Product Portfolio

Cipher Pharmaceuticals continues to focus on expanding its product portfolio and maximizing the value of its isotretinoin products. The launch of Absorica LD and other strategic initiatives are expected to enhance long-term value for the company[1].

Key Takeaways

• Market Share: Absorica LD, along with its branded and generic versions, holds a significant market share in the U.S. isotretinoin prescription market.
• Revenue Growth: Strong revenue growth has been reported by Cipher Pharmaceuticals, driven by licensing revenue from Absorica and its generic versions.
• Financial Health: The company has a strong balance sheet with significant cash reserves and no debt.
• Competitive Landscape: The isotretinoin market is highly competitive, with generic competition posing challenges to branded products.
• Strategic Initiatives: Partnerships and the launch of new formulations are crucial for maintaining market share and driving growth.

FAQs

What is Absorica LD used for?

Absorica LD is used for the treatment of severe recalcitrant nodular acne in patients 12 years and older.

Who developed Absorica LD?

Absorica LD was developed by Sun Pharma as a new formulation of the existing drug Absorica.

What is the market share of Absorica LD in the U.S.?

As of Q2 2021, the market share of Absorica and its authorized generic version, including Sun Pharma's Absorica LD, was approximately 6.2% in the U.S. isotretinoin prescription market.

How has the financial performance of Cipher Pharmaceuticals been affected by Absorica LD?

Cipher Pharmaceuticals has reported strong revenue growth and increased adjusted EBITDA and net income, partly driven by the performance of Absorica and its generic versions.

What are the challenges faced by Absorica LD in the market?

The main challenges include generic competition and pricing pressures, which can reduce profit margins and market share.

Sources

1. Cipher Pharmaceuticals Reports 30% Revenue Growth and 40% Adjusted EBITDA Growth in Second Quarter of 2021 - Cipher Investor Room.
2. Cipher Pharmaceuticals Reports Strong First Quarter 2022 Financial Results - Cipher Investor Room.
3. Isotretinoin Capsule Market Size, Growth, Global Forecast, 2032 - Business Research Insights.
4. 211913Orig1s000 - accessdata.fda.gov - FDA.
5. Cipher Pharmaceuticals Reports Third Quarter 2020 Financial Results - Newswire.