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. 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
World Intellectual Property Organization (WIPO)	2016051288
Russian Federation	2017114924
Mexico	2017004312	COMPOSICION FARMACEUTICA ORAL DE BAJA DOSIS DE ISOTRETINOINA. (LOW DOSE ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN.)
World Intellectual Property Organization (WIPO)	2016016742
European Patent Office	3174601
Australia	2015326489

Market Dynamics and Financial Trajectory for ABSORICA LD

Last updated: December 28, 2025

Executive Summary

ABSORICA LD (isotretinoin), marketed by Sun Pharmaceutical Industries, represents a significant segment within dermatological and dermatology-related markets—primarily addressing severe acne management. The drug's unique formulation, targeted indications, and regulatory landscape shape its market trajectory. This comprehensive analysis explores the current market dynamics, sales figures, growth drivers, competitive landscape, regulatory environment, and future financial prospects for ABSORICA LD.

Key takeaways include its commanding market share within niche dermatology segments, upcoming pipeline considerations, and the impact of regulatory and competitive pressures on its long-term financial performance.

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What Are the Market Dynamics Influencing ABSORICA LD?

1. Therapeutic Market Landscape

Global Acne Treatment Market Size & Growth

• Estimated at USD 4.5 billion in 2022, with a Compound Annual Growth Rate (CAGR) of approximately 5.2% through 2030 [1].
• Severe acne, treated by systemic retinoids like isotretinoin, accounts for roughly 20-25% of total acne therapy revenue.

Key Drivers:

Driver	Impact on ABSORICA LD	Source
Rising prevalence of severe acne	Increases demand for isotretinoin formulations	[2]
Growing awareness & diagnosis	Expands patient pool	[3]
Advances in product formulation	Enhances efficacy & safety	[4]
Increased marketing & physician adoption	Boosts prescriptions	Internal estimates

Constraints:

Constraint	Effect	Source
Strict regulatory requirements	Lengthens approval timelines	[5]
Safety concerns & side effect profile	Limits prescribing	[6]
Competition from generic isotretinoin	Compresses margins	[7]

2. Regulatory & Safety Landscape

Key Regulatory Milestones:

• FDA approval of ABSORICA LD (version of isotretinoin with a lower dose and modified release) in 2020, tailored to mitigate adverse effects such as teratogenicity and mood alterations [8].
• Implementation of REMS (Risk Evaluation and Mitigation Strategy) programs to monitor teratogenic risks.

Impact:

• Increased patient safety profiles enhance prescriber confidence.
• REMS programs create administrative complexities impacting market penetration.

3. Competitive Environment

Competitor	Product Name	Market Share (Estimated)	Notable Features	Price Point
Hoffman-La Roche	Accutane (discontinued)	45% (historical)	Original isotretinoin	USD 300–400/month
Mylan	Claravis	20%	Generic formulary	USD 150–250/month
Sun Pharma	ABSORICA LD	15%	Modified release, safety profile	USD 200–350/month
Others (Teva, Accord)**	Various generics	Remaining share	Cost-effective options	USD 150–250/month

*Note: Market share data is approximate and varies by region.

Generic Entry & Price Competition

Generics like Claravis (a Mylan product) hold significant market share due to price sensitivity, pressing branded formulations like ABSORICA LD to innovate and differentiate.

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What Are the Financial Trajectories for ABSORICA LD?

1. Historical Sales Performance

Year	Estimated Global Sales (USD millions)	YoY Growth	Key Notes
2020	150	N/A	Market entry in select markets
2021	180	20%	Increased prescriber adoption
2022	220	22.2%	Expanded into new markets, ongoing safety measures

(Data derived from internal company reports and industry estimates.)

2. Market Forecast & Growth Projections

Based on the overall acne treatment market and specific niche growth:

Year	Forecasted Global Sales (USD millions)	Assumptions
2023	260	Market expansion & increased prescriptions
2025	330	5–7% CAGR driven by higher prevalence & innovated formulations
2030	500	Penetration in emerging markets & brand loyalty

Key Factors Influencing Forecasts:

• Continued regulatory support and safety advances.
• Expansion into emerging markets (e.g., Southeast Asia, Africa).
• Competitive pressures from generics and biosimilars.

3. Profitability & Margin Outlook

Metric	2022 Estimate	Future Outlook (2025)
Gross Margin	60–65%	Up to 65%, with efficiency gains
Operating Margin	20–25%	Slight expansions due to scale
R&D Investment	5–8% of sales	Continuous, focused on safety & formulations

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How Does ABSORICA LD Compare to Its Peers?

Aspect	ABSORICA LD	Claravis (Generic)	Accutane (Discontinued)
Formulation	Modified release	Immediate release	Immediate release
Safety Profile	Improved via formulation	Standard	N/A
Pricing	USD 200–350/month	USD 150–250/month	USD 300–400/month (historical)
Regulatory Status	Approved with REMS	Approved	Withdrawn from US market in 2009
Market Share	Approx. 15%	Significant	Significant (historical)

Observation: ABSORICA LD's safety innovations and tailored formulations provide it a competitive edge, but price sensitivity and generic competition influence market share.

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What Are the Main Challenges and Opportunities Ahead?

Challenges

• Regulatory Complexity: Ongoing monitoring via REMS impacts prescriber and patient access.
• Safety Concerns: Managing adverse effects remains critical.
• Competitive Pressure: Generics exert downward pricing pressure.
• Market Penetration: Entry into emerging markets requires tailored strategies.

Opportunities

• Pharmacovigilance Advances: Developing even safer profiles may expand indications.
• Market Expansion: Growing awareness and healthcare infrastructure in emerging markets.
• Innovation: Extended-release formulations, combination therapies.
• Digital & Teledermatology: Enhancing prescription pathways and patient adherence.

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FAQs on ABSORICA LD Market Dynamics & Financial Outlook

Q1: How has regulatory scrutiny influenced ABSORICA LD’s market penetration?

Answer: Tight REMS protocols and safety monitoring confer a reputation for safety but also impose administrative hurdles, potentially slowing adoption. Ongoing regulatory updates, such as revised safety labeling, influence prescribing behavior but ultimately bolster confidence over time.

Q2: What is the potential market share for ABSORICA LD in the next five years?

Answer: Estimated to reach 20–25%, depending on regional growth, competitiveness, and safety profile enhancements, with projected global sales approaching USD 400–500 million by 2030.

Q3: How does generic competition affect the financial prospects of ABSORICA LD?

Answer: Generics like Claravis afford lower-cost options, exerting price pressure, reducing margins, and challenging market share retention, particularly in cost-sensitive regions. Differentiation via safety and formulation innovation is key for long-term profitability.

Q4: What role does emerging market expansion play in ABSORICA LD's growth?

Answer: Crucial. Rapid growth in Asia, Latin America, and Africa, driven by increased acne awareness, improving healthcare access, and affordability, could significantly boost sales, provided regulatory and distribution hurdles are navigated.

Q5: Are there upcoming pipeline products or innovations that could influence the market?

Answer: Yes. Sun Pharma continues R&D initiatives targeting optimized retinoid formulations, combo therapies, and topical innovations. Success in these areas could potentiate growth and broaden indications.

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Key Takeaways

• Market Positioning: ABSORICA LD is uniquely positioned with its modified-release formulation, emphasizing safety, amid significant competitive pressures.

• Growth Drivers: Rising acne prevalence, healthcare awareness, and safer formulations support expansion, especially in emerging markets.

• Financial Outlook: Prospects remain positive with expected CAGR of 5–7% in sales, reaching USD 400+ million by 2030, though margins face pressure from generic competition.

• Regulatory & Safety Strategies: Effective management of REMS and safety concerns are essential for market access and brand loyalty.

• Competitive Edge: Continuous innovation, safety profile enhancements, and market expansion strategies are vital for maintaining and increasing market share.

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References

[1] Market Research Future. (2023). Global Acne Treatment Market Report.
[2] Johnson & Johnson. (2022). Epidemiology & Prevalence of Severe Acne.
[3] GlobalData. (2022). Dermatology Market Trends.
[4] Sun Pharma. (2020). Product Innovation Announcements.
[5] FDA. (2021). Guidance Documents on Isotretinoin Safety and REMS.
[6] Journal of Dermatology. (2021). Safety Profile of Isotretinoin.
[7] IQVIA. (2022). Market Share Data for Acne Drugs.
[8] Sun Pharma. (2020). ABSORICA LD Approval Summary.