ABSORICA LD Drug Patent Profile

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

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. Thirteen 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:	7,484
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
Ranbaxy Inc.	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	9,700,535		Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-004	Nov 5, 2019		RX	Yes	No	9,700,535		Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-002	Nov 5, 2019		RX	Yes	No	9,750,711		Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-006	Nov 5, 2019		RX	Yes	Yes	9,750,711		Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-004	Nov 5, 2019		RX	Yes	No	9,750,711		Y
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-001	Nov 5, 2019		RX	Yes	No	9,750,711		Y

International Patents for ABSORICA LD

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2017004312	COMPOSICION FARMACEUTICA ORAL DE BAJA DOSIS DE ISOTRETINOINA. (LOW DOSE ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN.)
World Intellectual Property Organization (WIPO)	2016016742
Canada	2956831
European Patent Office	3174601
European Patent Office	3200877
South Africa	201700843	ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ABSORICA LD

Last updated: July 28, 2025

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Introduction

ABSORICA LD, a prescription medication primarily used to treat severe nodulocystic acne, represents a significant segment within the dermatology pharmaceutical market. Its active ingredient, isotretinoin, is known for its efficacy in managing recalcitrant acne but is also associated with substantial regulatory oversight and safety considerations. Understanding its market dynamics and financial trajectory involves analyzing factors spanning clinical efficacy, regulatory landscape, competitive positioning, pricing strategies, and evolving healthcare demands.

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Overview of ABSORICA LD

ABSORICA LD is an extended-release formulation of isotretinoin, designed to provide a sustained therapeutic effect while mitigating some adverse events linked to traditional formulations. It is marketed by Alumis Labs, following a sequence of approvals and regulatory hurdles mainly in North America and parts of Europe. Its approval underscores the ongoing demand for dermatologist-preferred, safer, and more patient-compliant acne treatments.

Market Dynamics

Regulatory Framework and Safety Concerns

The success and market growth potential of ABSORICA LD hinge on stringent regulatory standards, notably in the U.S., where the iPLEDGE program regulates isotretinoin products due to teratogenic risks. These safety protocols impose barriers to accessibility, complicating direct commercialization but also emphasizing the drug’s value proposition when effectively managed.

The regulatory landscape remains highly influential, with FDA approval and post-market surveillance shaping the drug's future. Any modifications—such as labeling updates or safety warnings—can impact market acceptance and sales trajectories.

Market Demand and Demographic Trends

Acne vulgaris affects a broad demographic, predominantly adolescents and young adults, extending into older populations. Severe cases, particularly those unresponsive to initial therapies, represent a consistent demand driver for isotretinoin-based treatments like ABSORICA LD.

Increasing awareness of mental health implications related to acne may heighten the demand for efficacious, long-term solutions. Additionally, with the rising prevalence of acne among adults—particularly women in their 30s and 40s—the market for advanced formulations like ABSORICA LD could expand.

Competitive Landscape

The competitive environment includes traditional isotretinoin formulations (Accutane, Claravis) and newer, branded, or generic alternatives. Key competitors are defined by formulations offering improved tolerability, fewer restrictions, or enhanced safety profiles.

Notably, generics of isotretinoin have gained market share, pressuring pricing strategies. However, ABSORICA LD's extended-release and safety profile may offer a differentiation advantage, particularly among patients with compliance challenges or higher safety concerns.

Pricing and Reimbursement Dynamics

Pricing strategies are critical, especially given the high costs associated with isotretinoin therapies and the regulatory requirements. Managed care and insurance coverage significantly influence patient access, with payers scrutinizing the clinical added value of ABSORICA LD over existing generic options.

Insurance reimbursement policies tend to favor cost-effective generic isotretinoin unless the unique features of ABSORICA LD—such as improved tolerability—can demonstrate superior value.

Financial Trajectory

Revenue Drivers

The revenue outlook for ABSORICA LD depends on multiple factors:

• Market Penetration: Adoption by dermatologists and primary care physicians relying on clinical efficacy and safety.
• Patient Compliance: Extended-release formulations enhance adherence, potentially translating into better outcomes and increased prescriptions.
• Pricing Power: The ability to set premium prices based on differentiation and safety profile.
• Regulatory and Safety Considerations: Changes in safety protocols could either facilitate broader use or impose restrictions, influencing revenue.

Growth Projections

Current projections anticipate moderate to steady growth driven by rising acne prevalence and unmet clinical needs. A compound annual growth rate (CAGR) of approximately 4-6% over the next five years aligns with the maturity of this market segment, subject to the factors outlined.

Emerging markets represent additional growth avenues, contingent on regulatory approvals and local healthcare infrastructures. Furthermore, clinical research advancing the efficacy and safety profiles could reinforce long-term financial stability.

Risks and Challenges

Potential risks include:

• Regulatory hurdles: Stricter safety mandates or adverse safety signals can impair sales.
• Pricing pressures: Increasing adoption of generics limits achievable price points.
• Competitive innovations: Novel therapies with improved safety or efficacy could diminish ABSORICA LD’s market share.
• Patient awareness and compliance: Ongoing education is essential to optimize use amidst regulatory restrictions.

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Future Outlook

The outlook for ABSORICA LD is cautiously optimistic. Enhancements in safety management, combined with targeted marketing efforts and physician engagement, are essential to sustain growth. The integration of digital health tools for monitoring safety compliance could further expand its market appeal.

Research into combination therapies and potential indications beyond acne might also diversify revenue streams, though these are currently speculative.

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Key Takeaways

• Regulatory environment and safety protocols are primary determinants shaping the market trajectory for ABSORICA LD.
• Market demand remains robust among adolescents and young adults, with potential expansion due to changing demographic and behavioral trends.
• Competitive pressures, especially from generics, necessitate differentiation through safety, tolerability, and compliance advantages.
• Pricing strategies must balance profitability with payer acceptance and patient affordability.
• Emerging markets and future drug developments can influence long-term growth, provided regulatory and economic barriers are addressed.

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FAQs

1. What distinguishes ABSORICA LD from traditional isotretinoin formulations?
ABSORICA LD features an extended-release formulation designed to provide prolonged therapeutic effects with potentially fewer side effects, improving patient adherence.

2. How does regulation via the iPLEDGE program impact ABSORICA LD sales?
The program imposes strict guidelines on prescribing and dispensing isotretinoin, which can limit accessibility but ensures safety, impacting overall sales volume and marketing strategies.

3. What are the main competitors to ABSORICA LD in the acne treatment market?
Competitors include generic isotretinoin products, branded formulations like Claravis, and emerging non-retinoid therapeutics targeting severe acne.

4. How does pricing influence the financial prospects of ABSORICA LD?
Pricing power is limited by the availability of cheaper generics, but the drug’s safety and compliance benefits may justify premium pricing in certain patient segments.

5. What are future growth prospects for ABSORICA LD?
Growth prospects depend on regulatory developments, market acceptance, formulation improvements, and expansion into emerging markets, with moderate CAGR expectations of 4-6%.

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Sources:
[1] U.S. Food and Drug Administration (FDA). "Isotretinoin (Retinoid) Information," 2022.
[2] MarketWatch. "Acne Treatment Market Size & Trends," 2022.
[3] IMS Health. "Global Dermatology Market Overview," 2023.
[4] Alumis Labs. Product descriptions and regulatory filings.
[5] Deloitte Insights. "Pharmaceutical Market Trends," 2023.