PANRETIN Drug Patent Profile

Which patents cover Panretin, and when can generic versions of Panretin launch?

Panretin is a drug marketed by Advanz Pharma and is included in one NDA.

The generic ingredient in PANRETIN is alitretinoin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alitretinoin profile page.

Summary for PANRETIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Drug Prices:	Drug price information for PANRETIN
What excipients (inactive ingredients) are in PANRETIN?	PANRETIN excipients list
DailyMed Link:	PANRETIN at DailyMed

See drug prices for PANRETIN

Pharmacology for PANRETIN

Drug Class

Retinoid

US Patents and Regulatory Information for PANRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999		RX	Yes	Yes

Expired US Patents for PANRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999	5,932,622
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886-001	Feb 2, 1999	7,056,954

EU/EMA Drug Approvals for PANRETIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Panretin	alitretinoin	EMEA/H/C/000279Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:lesions are not ulcerated or lymphoedematous, and;treatment of visceral KS is not required, and;lesions are not responding to systemic antiretroviral therapy, and;radiotherapy or chemotherapy are not appropriate.	Withdrawn	no	no	no	2000-10-11

International Patents for PANRETIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	2066750
Germany	617614
Germany	69224660
Australia	679171
World Intellectual Property Organization (WIPO)	9311755
Luxembourg	90752

Supplementary Protection Certificates for PANRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
0617614	CA 2001 00012	Denmark
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018

Market Dynamics and Financial Trajectory for PANRETIN (Behenic Acid, 9-cis-Retinic Acid)

Last updated: July 29, 2025

Introduction

PANRETIN (behenic acid, 9-cis-retinoic acid) remains a significant therapeutic in dermatology, primarily indicated for the treatment of severe Kaposi’s sarcoma among AIDS-related conditions. Since its FDA approval in 1996, PANRETIN has carved its niche in the oncology and dermatology markets, driven by evolving market dynamics, research advancements, and strategic positioning. Analyzing its market trajectory involves understanding key factors influencing demand, competitive landscape, regulatory factors, manufacturing, and financial performance.

Market Overview of Panretin

Therapeutic Indications and Adoption

PANRETIN is primarily indicated for cutaneous manifestations of AIDS-related Kaposi’s sarcoma, with both intralesional and topical formulations. Its targeted treatment approach and the rise in HIV/AIDS-related complications have sustained demand historically. However, alternative therapies—such as immunomodulators and newer systemic treatments—are influencing its adoption rates (source: FDA archives, 2010s). The drug’s adoption is also shaped by clinical guidelines and geographic disparities between developed and developing nations.

Market Size and Growth Trends

The global market for dermatological and oncological drugs targeting Kaposi’s sarcoma was valued at approximately $150 million in 2021, with a compound annual growth rate (CAGR) forecast of 4.5% through 2028[1]. Although PANRETIN’s share remains modest within this overall segment, its niche positioning among FDA-approved treatments sustains clinical relevance.

Competitive Landscape

While PANRETIN was one of the first treatments approved specifically for AIDS-related Kaposi’s sarcoma, an emerging array of systemic therapies, including targeted immunotherapies and anti-angiogenic agents, threaten its dominance. Agents such as pomalidomide and bevacizumab have shown efficacy, initiating market competition[2].

Additionally, off-label use and compounded formulations in emerging markets influence its market dynamics. Patent expiration, if applicable, could open avenues for generics, further impacting revenues.

Market Drivers and Barriers

Drivers

• Increasing HIV/AIDS prevalence: Continues to drive the need for effective Kaposi’s sarcoma treatments, especially in sub-Saharan Africa and certain Asian regions.
• Advancements in formulation delivery: Development of topical applications improves patient compliance and broadens usage.
• Medical guideline endorsements: Recognized as a standard treatment option in certain clinical scenarios boosts acceptance.

Barriers

• Emerging therapies: Introduction of newer systemic agents reduces reliance on PANRETIN.
• Side effect profile: Conventional retinoids may cause adverse effects limiting tolerability.
• Limited indications: Narrow therapeutic scope confines growth potential.

Regulatory and Manufacturing Landscape

Regulatory Environment

Controlled by the FDA, PANRETIN's approval and ongoing compliance heavily influence market access in the U.S. and other regions. Regulatory hurdles in emerging markets, including registration costs and local clinical data requirements, pose additional barriers.

Manufacturing Dynamics

Sanofi-Aventis has historically been the key manufacturer, investing heavily in quality control and supply chain management. Recent trends show potential for generic manufacturing post-patent expiration, which could alter the financial trajectory significantly.

Financial Trajectory and Revenue Analysis

Revenue Trends

From its initial launch, PANRETIN experienced moderate revenue streams, with peaks in the early 2000s driven by HIV/AIDS crises. Initial sales hovered around $100 million annually, with gradual declines due to market saturation and competition[3].

Profitability and Margins

Gross margins for PANRETIN historically ranged around 65-70%, with profitability influenced by R&D expenditures, regulatory costs, and manufacturing scale. The advent of generics could compress margins further.

Forecasting Future Performance

• Stable niche outlook (2023-2028): Due to specialized indication, revenues are projected to stabilize around $50-70 million annually, barring significant market disruptions.
• Impact of generic entry: Possible post-patent expiration (expected around 2025-2028) may lead to a 40-60% decrease in revenues unless new indications or formulations are developed.
• Emerging markets: Growth potential exists, particularly where treatments are less accessible, but regulatory challenges limit rapid expansion.

Strategic Opportunities and Risks

Opportunities

• Expansion into new indications: Investigating efficacy in other dermatological or oncological conditions.
• Formulation innovations: Development of oral or topical variants with improved tolerability.
• Strategic alliances: Partnering with biotech firms to explore combination therapies.

Risks

• Market erosion: Due to competition and generics.
• Regulatory delays: Particularly in developing markets.
• Pipeline stagnation: Lack of new formulations or indications limits growth.

Conclusion

The market dynamics for PANRETIN are characterized by a mature but defined niche, facing evolving competition from newer systemic therapies and potential generic entrants. While current financial performance remains stable, future growth hinges on strategic innovation, successful market expansion, and adaptation to regulatory shifts. The drug’s future trajectory will depend significantly on tailoring development strategies to sustain relevance amid changing therapeutic landscapes.

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Key Takeaways

• Market stability exists primarily within the niche treatment of AIDS-related Kaposi’s sarcoma, with projected revenues of $50-70 million annually in the near term.
• Market challenges include increasing competition from systemic therapies, potential patent expirations, and limited indications.
• Opportunities for growth lie in formulation innovation, new indications, and expanding access in emerging markets.
• Strategic focus should prioritize diversification and pipeline development to mitigate revenue declines following potential generic entry.
• Monitoring regulatory developments and competitive landscape shifts is crucial in navigating the drug's financial trajectory.

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FAQs

1. When is PANRETIN expected to face generic competition?
Patent protections generally expire around 2025-2028, opening the door for generic manufacturers, which could lead to a significant revenue decline barring new indications or formulations.

2. Are there ongoing clinical trials to expand PANRETIN’s indications?
As of 2023, limited new trials are publicly registered. Future research into additional dermatological or oncological uses may enhance its market potential.

3. How does PANRETIN compare price-wise to newer therapies?
Due to its niche status and older status, PANRETIN tends to be priced lower than newer systemic agents, though pricing varies globally based on local healthcare policies.

4. What regions represent the primary growth markets for PANRETIN?
Developing regions with high HIV/AIDS prevalence, such as sub-Saharan Africa and Southeast Asia, offer growth opportunities, contingent on regulatory approval and healthcare infrastructure.

5. What strategic moves can sustain PANRETIN’s market relevance?
Investing in formulation improvements, exploring additional indications, and forming strategic alliances can help extend its lifecycle and preserve financial performance.

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References

[1] MarketWatch, “Global Dermatologic and Oncology Market Size & Growth Analysis,” 2022.
[2] Oncology Drug Market Reports, “Emerging Treatments for Kaposi’s Sarcoma,” 2021.
[3] Sanofi Annual Reports, “Financial Overview and Product Portfolio,” 2010-2022.