ABSORICA Drug Patent Profile

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

Absorica is a drug marketed by Sun Pharm Inds Inc and Sun Pharm and is included in two NDAs. There are two patents protecting this drug and five Paragraph IV challenges.

The generic ingredient in ABSORICA 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

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

Summary for ABSORICA

US Patents:	0
Applicants:	2
NDAs:	2
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
Drug Sales Revenues:	Drug sales revenues for ABSORICA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSORICA
What excipients (inactive ingredients) are in ABSORICA?	ABSORICA excipients list
DailyMed Link:	ABSORICA at DailyMed

See drug prices for ABSORICA

See drug sales revenues for ABSORICA

Recent Clinical Trials for ABSORICA

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

Sponsor	Phase
Children's Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 2
Ranbaxy Inc.	Phase 4

See all ABSORICA clinical trials

Pharmacology for ABSORICA

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for ABSORICA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSORICA	Capsules	isotretinoin	25 mg	021951	1	2016-05-16
ABSORICA	Capsules	isotretinoin	35 mg	021951	1	2015-11-25
ABSORICA	Capsules	isotretinoin	10 mg	021951	1	2013-06-20
ABSORICA	Capsules	isotretinoin	20 mg	021951	1	2013-01-07
ABSORICA	Capsules	isotretinoin	40 mg	021951	1	2012-12-31

US Patents and Regulatory Information for ABSORICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012	AB2	RX	Yes	No
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-006	Nov 5, 2019		RX	Yes	Yes			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-001	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	AB2	RX	Yes	No
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-003	Nov 5, 2019		DISCN	Yes	No			Y

Expired US Patents for ABSORICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014

International Patents for ABSORICA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1318791	COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN)
World Intellectual Property Organization (WIPO)	0224172
Portugal	1318791
Brazil	102013032172	composição farmacêutica semissólida de isotretinoína
European Patent Office	2964195	COMPOSITION SEMI-SOLIDE PHARMACEUTIQUE D'ISOTRÉTINOÏNE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN)

ABSORICA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Absorica

Introduction

Absorica, a brand of isotretinoin, is a crucial drug in the treatment of severe acne, particularly among adolescents and young adults. This article delves into the market dynamics and financial trajectory of Absorica, highlighting key factors driving its market performance and the financial outcomes for its manufacturer, Cipher Pharmaceuticals.

Market Size and Growth of Isotretinoin Drugs

The isotretinoin drugs market, which includes Absorica, is projected to grow significantly. As of 2023, the market size was valued at USD 1337 million and is expected to reach USD 2053 million by 2031, growing at a CAGR of 4.88% from 2024 to 2031[3][4].

Drivers of Market Growth

Several factors are driving the growth of the isotretinoin market, including:

Increasing Incidence of Severe Acne

The rising prevalence of severe acne among adolescents and young adults is a major driver. Severe acne can lead to significant physical and emotional distress, increasing the demand for effective treatments like Absorica[3].

Enhanced Awareness and Diagnosis

Improved awareness about skin conditions and advancements in dermatology have led to more people seeking medical treatments for acne. Dermatologists are more likely to prescribe isotretinoin for severe cases, boosting its market demand[3].

Technological Advancements in Drug Formulations

Investments in research and development to explore the full potential of isotretinoin and minimize its side effects are expanding market opportunities[3].

Availability and Accessibility

The increasing availability of isotretinoin through various distribution channels, including online pharmacies, enhances its accessibility to a broad range of users[3].

Regional Market Performance

North America

North America dominates the global isotretinoin drugs market, driven by developed healthcare infrastructure, favorable government regulations, and high prevalence of skin problems. The region is anticipated to grow at a CAGR of 5.26% during the forecast period[4].

Europe

Europe is expected to grow at a CAGR of 3.84% over the forecast period, driven by rising cases of genetic disorders and skin cancer, and increasing healthcare spending[4].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market, driven by the presence of key players like Sun Pharma and Dr. Reddy's Laboratories Ltd, and increasing funding from investors[4].

Financial Performance of Cipher Pharmaceuticals

Revenue Growth

In the second quarter of 2021, Cipher Pharmaceuticals reported a 30% increase in total revenue to $6.1 million, driven by growth in licensing and product revenues. Licensing revenue from Absorica in the U.S. increased by 25% to $2.4 million compared to the same period in 2020[1].

Licensing Revenue

Licensing revenue from Absorica has been a significant contributor to Cipher's financial performance. In Q2 2021, Absorica and its authorized generic version held a market share of approximately 4.2%, while the combined market share including Sun Pharma's Absorica LD® was around 6.2%[1].

Product Revenue

Product revenue from Epuris, another key product, increased by $1.2 million to $3.1 million in Q2 2021, contributing to the overall product revenue growth of 65%[1].

Adjusted EBITDA and Earnings Per Share

Adjusted EBITDA increased by 40% to $4.1 million in Q2 2021, and earnings per common share increased by 450% to $0.11. This strong financial performance was driven by the growth in revenue and efficient cost management[1].

Cash Flow and Balance Sheet

Cipher generated $7.6 million in cash from operating activities in the six months ending June 30, 2021, and ended the quarter with a strong balance sheet, having $16.1 million in cash and no debt[1].

Strategic Partnerships and Milestones

Partnership with Sun Pharmaceutical

Cipher's partnership with Sun Pharmaceutical has been instrumental in broadening its isotretinoin portfolio. The launch of Absorica AG with Sun Pharma has helped in serving different segments of the market and maximizing the value of the portfolio[1].

Extended Distribution and Supply Agreement

In 2022, Cipher extended its distribution and supply agreement with Sun Pharmaceutical until December 31, 2026, further solidifying its position in the market[5].

Outlook and Future Prospects

Key Milestones

Cipher anticipates several key milestones that will continue to enhance long-term value, including the expansion of its isotretinoin portfolio and the completion of clinical studies for new products[1][5].

Market Expansion

The increasing demand for isotretinoin, coupled with the company's strategic partnerships and strong financial performance, positions Cipher for continued growth in the isotretinoin market.

"Currently, in our isotretinoin portfolio, Cipher is receiving royalties from Sun Pharma for the branded product, Absorica, the authorized generic, as well as ABSORICA LD®," noted **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," added **Mr. Mull**[1].

Challenges and Constraints

Side Effects and Regulatory Controls

Despite the growth potential, the isotretinoin market faces challenges such as significant side effects and stringent regulatory controls. These factors can constrain market growth and require continuous investment in research and development to mitigate these issues[3].

Key Takeaways

• The isotretinoin market, including Absorica, is projected to grow at a CAGR of 4.88% from 2024 to 2031.
• North America dominates the global market, with Europe and Asia-Pacific also showing significant growth.
• Cipher Pharmaceuticals has seen strong revenue and EBITDA growth driven by its isotretinoin portfolio.
• Strategic partnerships, such as the one with Sun Pharmaceutical, are crucial for market expansion.
• Despite growth, the market faces challenges related to side effects and regulatory controls.

FAQs

What is the projected market size of the isotretinoin drugs market by 2031?

The isotretinoin drugs market is projected to reach USD 2053 million by 2031[3][4].

Which region dominates the global isotretinoin drugs market?

North America dominates the global isotretinoin drugs market due to its developed healthcare infrastructure and favorable government regulations[4].

How has Cipher Pharmaceuticals' revenue from Absorica performed in recent years?

In Q2 2021, licensing revenue from Absorica in the U.S. increased by 25% to $2.4 million compared to the same period in 2020[1].

What are the key drivers of the isotretinoin market growth?

Key drivers include the increasing incidence of severe acne, enhanced awareness and diagnosis, technological advancements, and improved availability and accessibility[3].

What are the challenges facing the isotretinoin market?

Challenges include significant side effects, stringent regulatory controls, and high costs associated with the drug[3].

Sources

1. Cipher Pharmaceuticals. Cipher Reports 30% Revenue Growth and 40% Adjusted EBITDA Growth in Second Quarter of 2021, Driven by Strength in Epuris and Absorica. August 12, 2021.
2. Biospace. Cipher Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results. March 18, 2021.
3. Verified Market Research. Isotretinoin Drugs Market Size, Share, Trends, Growth & Forecast. 2023.
4. Straits Research. Isotretinoin Drugs Market Size, Share, Analysis and Forecast to 2031. March 22, 2023.
5. Cipher Pharmaceuticals. Cipher Pharmaceuticals Reports Strong First Quarter 2022 Financial Results. May 12, 2022.