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. Thirteen 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
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
Sun Pharmaceutical Industries Limited	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
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-001	Nov 5, 2019		RX	Yes	No			Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-005	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	021951-003	May 25, 2012
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-006	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-005	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-005	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012

International Patents for ABSORICA

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

Country	Patent Number	Title	Estimated Expiration
Germany	60104206
Austria	E270544
Australia	8943801	Pharmaceutical semi-solid composition of isotretinoin
Brazil	102013032172	composição farmacêutica semissólida de isotretinoína
Portugal	1318791
Spain	2225600
Austria	270544

Market Dynamics and Financial Trajectory for ABSORICA

Last updated: July 27, 2025

Introduction

ABSORICA (or its generic equivalent isotretinoin) represents a significant therapeutic agent within the dermatology segment, primarily used for severe recalcitrant nodular acne. As a cornerstone in acne management, its market landscape has evolved amidst regulatory, competitive, and technological shifts. This analysis delineates the current market dynamics and projects the financial trajectory of ABSORICA, emphasizing factors affecting its commercial viability and growth potential.

Market Overview

Therapeutic Profile and Clinical Value

ABSORICA, a branded formulation of isotretinoin, is distinguished by its efficacy in treating severe acne cases unresponsive to conventional therapies. Its mechanism involves reducing sebaceous gland activity and keratinocyte proliferation, leading to significant acne clearance. While highly effective, its administration is associated with notable safety concerns, including teratogenicity and lipid abnormalities, necessitating strict regulatory oversight and patient monitoring.

Market Size and Penetration

Globally, the dermatology drugs market encompasses a multi-billion dollar sector, with acne therapeutics accounting for a considerable share. In 2022, the global acne vulgaris treatment market was valued at approximately USD 4.5 billion, expected to grow at a compounded rate of about 5% annually through 2030 [1]. Within this, isolated formulations like ABSORICA hold a niche, primarily dominant in developed markets like the U.S., owing to high prescription rates, established clinical guidelines, and patient awareness.

Regulatory Landscape

The U.S. Food and Drug Administration (FDA) approved ABSORICA decades ago, with dosing and safety protocols evolving to minimize teratogenic risks—most notably the iPLEDGE risk management program [2]. Similar stringent frameworks exist in Europe and other jurisdictions, impacting market accessibility and prescribing patterns.

Market Drivers

Increasing Prevalence of Severe Acne

Rising prevalence of severe acne cases, especially among adolescents and young adults, propels demand for effective treatments like ABSORICA. Studies report that approximately 85% of teenagers experience some form of acne, with a subset suffering from severe, cystic or nodular acne [3].

Advances in Formulation and Safety Monitoring

Development of encapsulated and micro-dose formulations has improved tolerability. Concurrently, digital health tools facilitate patient adherence to monitoring protocols, making prescribers more comfortable with prescribing isotretinoin.

Growing Awareness and Physician Confidence

Greater awareness of acne's impact on quality of life and advances in understanding isotretinoin's safety profile have bolstered physician confidence, driving prescription volumes.

Patent Status and Market Exclusivity

While ABSORICA's patents have expired or are nearing expiration, exclusive marketing rights in certain regions—secured through formulation patents and regulatory data exclusivity—continue to support brand loyalty and higher price points.

Market Challenges

Safety and Regulatory Constraints

The teratogenic risk demands rigorous risk management programs, which can restrict prescription volume. The iPLEDGE program in the U.S., for instance, limits access, potentially constraining revenue flow.

Generic Competition

Generic isotretinoin products, offering similar efficacy at lower prices, erode branded ABSORICA's market share. The shift towards generics is driven by cost sensitivity among payers and patients.

Availability of Alternative Therapies

Emerging biologics, hormonal treatments, and novel topical agents provide alternative options, especially for mild to moderate acne, decreasing reliance on isotretinoin.

Safety Concerns and Side Effect Profile

Potential side effects such as hyperlipidemia, hepatic dysfunction, and mood changes heighten concerns, influencing prescription practices.

Financial Trajectory and Market Outlook

Current Revenue Streams

In North America, ABSORICA and similar isotretinoin formulations collectively generate annual revenues in the hundreds of millions, with peak sales historically exceeding USD 300 million for branded formulations [4]. Brand market shares are declining gradually due to generic competition, but high brand loyalty and effective safety management sustain revenue levels.

Projected Growth Trends

The global acne medication market is projected to grow at a CAGR of 5% through 2030. However, for ABSORICA, growth will hinge on several factors:

• Market Penetration: Expansion into emerging markets could offer new revenue streams, especially if regulatory barriers are addressed.
• Pricing Strategies: Maintaining premium pricing in light of generic competition requires demonstrating superior safety, tolerability, and dosing convenience.
• Product Innovation: Development of new formulations with improved safety profiles could restore growth momentum.

Impact of Regulatory and Patent Environment

Patent expirations and biosimilar entries could reduce branded prices, but adaptive strategies such as combination therapies or new delivery systems may mitigate revenue erosion.

Potential Market Expansion

The increasing recognition of the psychodermatological impact of acne, coupled with an aging demographic seeking longer-term management options, presents opportunities for maintaining or growing ABSORICA's market share, provided safety concerns are adeptly managed through digital monitoring and patient support programs.

Concluding Insights

While the core demand for severe acne treatment remains steady, ABSORICA's market trajectory faces headwinds from safety, regulatory, and generics-driven competition. Strategic investments in formulation improvements, rigorous safety monitoring, and educational outreach could sustain its relevance. Overall, the pharmaceutical sector's emphasis on personalized medicine and digital health integration is poised to influence ABSORICA’s financial performance positively.

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Key Takeaways

• The global acne treatment market is expanding at a moderate rate, with ABSORICA maintaining a significant share in severe acne management.
• Regulatory constraints—particularly safety monitoring protocols—limit prescription volumes but also reinforce brand credibility.
• Patent expirations and generic competition threaten revenue stability, necessitating innovation and value differentiation.
• Emerging markets and digital health tools present opportunities for growth and improved safety management, favoring positive financial trajectories.
• Long-term success hinges on balancing safety concerns with patient access, leveraging formulation advancements, and exploring expanded indications.

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FAQs

1. How does ABSORICA differ from generic isotretinoin formulations?
ABSORICA is a branded formulation with specific delivery technology and potentially optimized tolerability profiles. Its formulation may include unique release mechanisms or stabilizers, which can influence safety and efficacy perceptions, though active ingredients are chemically similar to generics.

2. What safety management protocols impact ABSORICA’s market?
The iPLEDGE program mandates pregnancy prevention measures, regular lipid and liver function testing, and patient education, which can restrict prescribing and influence market dynamics.

3. Are there new formulations or delivery methods for isotretinoin in development?
Yes. Companies are exploring microencapsulation, transdermal patches, and combination therapies to reduce side effects, enhance compliance, and differentiate their offerings.

4. How does the entry of biosimilars or generics affect ABSORICA’s revenue?
Generics introduce price competition, reducing revenue margins. Branded formulations rely heavily on prescriber loyalty, safety reputation, and patient support programs to maintain market share.

5. What is the future outlook for ABSORICA in emerging markets?
Growing healthcare infrastructure and increased awareness can expand access, but regulatory hurdles and cost considerations remain challenges. Tailored strategies addressing local safety and approval requirements are crucial for market penetration.

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Sources:
[1] Market Research Future, "Acne Treatment Market Statistics," 2022.
[2] FDA, "iPLEDGE Program," 2023.
[3] National Institute of Health, "Prevalence of Acne," 2022.
[4] IQVIA, "Pharmaceutical Sales Data," 2022.