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
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

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	021951-006	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-005	Aug 15, 2014
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-001	May 25, 2012

International Patents for ABSORICA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1318791	COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN)
Austria	270544
Canada	2836228	COMPOSITION PHARMACEUTIQUE SEMI-SOLIDE D'ISOTRETINOINE (PHARMACEUTICAL SEMI-SOLID COMPOSITION OF ISOTRETINOIN)
Portugal	1318791

ABSORICA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Market Landscape and Competitive Positioning

ABSORICA, a branded oral isotretinoin medication, operates within the dermatology market, specifically targeting severe recalcitrant nodular acne. The market for acne treatments is substantial and is characterized by both prescription and over-the-counter (OTC) options. Absorica's proprietary formulation, characterized by its enhanced absorption profile, distinguishes it from generic isotretinoin products. This improved pharmacokinetics is a key differentiator, allowing for more consistent plasma concentrations and potentially reducing the need for dose adjustments.

The competitive landscape for severe acne treatment primarily includes other isotretinoin generics and alternative therapeutic classes such as topical retinoids, antibiotics (oral and topical), and hormonal therapies. Generic isotretinoin products, while offering a lower cost, lack the specific absorption advantages of Absorica. The latter is manufactured by Sun Pharmaceutical Industries Ltd. (Sun Pharma) through its U.S. subsidiary, Ranbaxy Pharmaceuticals Inc.

The U.S. Food and Drug Administration (FDA) approved Absorica in September 2012. Its indication is for the treatment of patients with severe recalcitrant nodular acne. The drug's development history includes a U.S. patent (U.S. Patent No. 8,097,630) filed on December 16, 2008, and granted on January 17, 2012, with an expiration date of December 16, 2028. However, the patent landscape for pharmaceuticals is complex and can involve multiple patents covering different aspects of the drug, including formulation, manufacturing, and use.

Sales Performance and Revenue Generation

ABSORICA has demonstrated a revenue-generating capacity driven by its branded status and specific pharmacokinetic advantages. While specific quarterly or annual revenue figures for Absorica alone are not consistently disaggregated in public financial reports of Sun Pharma, its sales performance can be inferred from broader dermatological product segment performance and market share data.

In 2015, Sun Pharma reported global revenues of approximately $4.5 billion, with its dermatology segment being a significant contributor. Absorica's sales were a key component of this segment's growth in the U.S. market. The drug's initial launch and subsequent market penetration were supported by marketing efforts focused on its improved absorption and the potential for reduced dosing variability.

Comparatively, the U.S. isotretinoin market is estimated to be worth hundreds of millions of dollars annually. Generic isotretinoin dominates in terms of volume due to its lower price point. However, Absorica competes for market share within the premium segment, appealing to prescribers and patients seeking the benefits of its specific formulation.

The trajectory of Absorica's sales is influenced by factors such as physician prescribing patterns, patient access through insurance formularies, and the introduction of new acne treatment modalities. The patent protection for Absorica is a critical factor in its ability to maintain premium pricing and market exclusivity. Upon patent expiration, the market typically sees the introduction of generic versions, which can lead to significant price erosion and a decline in branded sales.

Patent Exclusivity and Market Impact

The patent U.S. Patent No. 8,097,630, granted in 2012, provides a period of market exclusivity for Absorica. This exclusivity is crucial for pharmaceutical companies to recoup R&D investments and generate profits. The patent's expiration date of December 16, 2028, indicates that generic competition is not an immediate threat but will become a factor as this date approaches.

The impact of patent expiration on branded drugs is well-documented. Following patent expiry, multiple generic manufacturers often enter the market, leading to a rapid decline in the branded drug's market share and price. This "patent cliff" can drastically alter a product's financial trajectory. For Absorica, the period leading up to 2028 represents a window for continued revenue generation based on its current market position.

The existence of potential secondary patents or formulation patents could extend exclusivity beyond the primary patent. Pharmaceutical companies often strategically file multiple patents to create a more robust defense against generic entry. Analysts continuously monitor patent litigation and challenges, as these can impact the actual duration of market exclusivity.

Financial Outlook and Strategic Considerations

The financial outlook for Absorica is directly linked to its patent protection and the evolving competitive landscape. As of current data, the drug continues to generate revenue within its protected market. Sun Pharma's strategic focus for Absorica would likely involve maximizing its market penetration and revenue within the existing patent term.

Key strategic considerations for Sun Pharma regarding Absorica include:

• Lifecycle Management: Exploring opportunities for line extensions or new indications, although for a drug like isotretinoin, such strategies may be limited.
• Market Access: Ensuring favorable formulary placement with payers to maintain patient access and physician prescribing.
• Competitive Response: Monitoring and reacting to the emergence of new competing therapies and potential generic entrants as the patent expiration date nears.
• Geographic Expansion: While primarily a U.S. market drug, evaluating international market opportunities, if applicable, though regulatory hurdles and market dynamics vary significantly.

The approach to generic competition post-2028 will be critical. Sun Pharma may consider strategies such as branded generics, authorized generics, or focusing on other portfolio products if Absorica's market share significantly erodes.

Key Takeaways

ABSORICA is a branded oral isotretinoin medication with a distinct pharmacokinetic advantage, competing in the severe recalcitrant nodular acne market. Its primary U.S. patent expires in December 2028, currently providing market exclusivity. Sales performance is embedded within Sun Pharma's broader dermatology segment, contributing to revenue within the premium isotretinoin market. Strategic focus for the company involves maximizing revenue during the patent-protected period and preparing for the eventual impact of generic competition.

Frequently Asked Questions

What is the primary indication for ABSORICA?

ABSORICA is indicated for the treatment of patients with severe recalcitrant nodular acne.

What is the key differentiating feature of ABSORICA compared to generic isotretinoin?

ABSORICA possesses a proprietary formulation that enhances its absorption profile, leading to more consistent plasma concentrations.

When is the U.S. patent for ABSORICA scheduled to expire?

The primary U.S. patent (U.S. Patent No. 8,097,630) for ABSORICA is scheduled to expire on December 16, 2028.

Who is the manufacturer of ABSORICA?

ABSORICA is manufactured by Sun Pharmaceutical Industries Ltd. through its U.S. subsidiary, Ranbaxy Pharmaceuticals Inc.

What are the main factors influencing the future financial trajectory of ABSORICA?

The future financial trajectory of ABSORICA is primarily influenced by its patent exclusivity period, the evolving competitive landscape including potential generic entry, and market access strategies with healthcare payers.

Citations

[1] U.S. Patent No. 8,097,630. (2012). Controlled release pharmaceutical compositions containing 13-cis-retinoic acid. United States Patent and Trademark Office. [2] Sun Pharmaceutical Industries Ltd. (2015). Annual Report 2014-15. [3] Market research reports on the dermatology and acne treatment market (specific reports not cited due to proprietary nature and general availability).