ARRANON Drug Patent Profile

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

Arranon is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in ARRANON is nelarabine. There are two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arranon

A generic version of ARRANON was approved as nelarabine by ZYDUS PHARMS on November 17^th, 2021.

Summary for ARRANON

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ARRANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	AP	RX	Yes	Yes

International Patents for ARRANON

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

Country	Patent Number	Title	Estimated Expiration
China	1031233
Netherlands	300302
Australia	8196091
Japan	2667873
European Patent Office	0294114	Composés antiviraux (Antiviral compounds)
Luxembourg	91370

Supplementary Protection Certificates for ARRANON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0294114	2007C/063	Belgium		PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
0294114	SPC/GB08/006	United Kingdom		PRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822
0294114	C00294114/01	Switzerland		PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
0294114	07C0058	France		PRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822
0294114	C300302	Netherlands		PRODUCT NAME: NELARABINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR BAAR ZOUT, ETHER OF ESTER; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
0294114	300302	Netherlands		300302, 20080527, EXPIRES: 20130526

Investment Scenario and Fundamentals Analysis for ARRANON (Alitretinoin)

Last updated: February 3, 2026

Overview
ARRANON (alitrentinoin) is a topical retinoid approved primarily for treating severe chronic hand eczema resistant to corticosteroids in several countries, including select European markets. The drug's market potential depends on regulatory approvals, clinical efficacy, competitive landscape, and patent or exclusivity status.

Market Position and Regulatory Status

• Approved Indications: Severe chronic hand eczema.
• Regulatory approvals: Approved in Germany, France, and other European countries; not yet cleared by FDA in the U.S. as of 2023.
• Market exclusivity: Patent life extends until approximately 2030, with some regional data exclusivities potentially extending revenue streams.

Market Dynamics

• Prevalence: Chronic hand eczema affects 2-5% of the population in Europe, with a subset requiring potent topical treatments.
• Current standards of care: Topical corticosteroids, calcineurin inhibitors, phototherapy, systemic immunosuppressants for refractory cases.
• Market size estimation: European market estimated at €200-€400 million annually, with growth potential in underserved or refractory patient populations.

R&D and Commercialization Factors

• Pipeline: Arranon is marketed; no significant pipeline competitors launched or in late-stage development for the same indication.
• Pricing: Presumed premium due to severity of condition and limited competition; priced at approximately €50-€150 per gram, depending on formulation and country.
• Reimbursement landscape: Covered by national health services in key countries, but reimbursement policies vary; uptake depends on physician awareness and prescribing patterns.

Financial Analysis and Investment Considerations

• Sales projections: Conservative estimates suggest €50-€100 million annual revenue in mature markets by 2025, based on penetration rates of 10-20% of eligible patients.
• Cost structure: R&D costs minimal post-approval; marketing costs focus on physician education and distribution channels.
• Profitability: Adjusted gross margin estimated at 70-80%, with EBITDA margins of 30-50% in profitable scenarios.

Risks and Challenges

• Regulatory approval gaps: Absence of FDA approval limits access, constraining revenue to European markets.
• Market penetration: Competition from off-label use and alternative treatments could restrict growth.
• Patent and exclusivity expiration: Approaching patent expiration raises the risk of generic competition reducing revenues post-2030.
• Safety profile: Usually well-tolerated, but reports of skin irritation and systemic absorption could impact safety perception and prescribing.

Comparative Analysis	Parameter	ARRANON (Alitretinoin)	Alternates (Topical corticosteroids, calcineurin inhibitors)	Biologics (for severe cases)
Market size	€200-€400 million (Europe)	Larger, but less targeted	Larger, but for different indications
Approval status	Approved in Europe	Widely approved	Approved for other dermatologic conditions
Price per treatment	€50-€150 per gram	Variable, generally lower	Significantly higher
Patent life remaining	Until ~2030	Patent expiry in mid-2020s	Patent extensions possible

Investment Outlook
ARRANON offers a niche but potentially profitable opportunity within the severe chronic hand eczema market in Europe. Its revenue potential hinges on successful commercialization, market penetration, and adherence to safety protocols. The absence of FDA approval limits upside in North America, but ongoing efforts could expand the footprint. Risks primarily include competitive pressure, regulatory delays, and patent expiry.

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Key Takeaways

• ARRANON is approved only in parts of Europe for severe hand eczema, with an estimated annual revenue of up to €100 million during peak penetration.
• It benefits from limited direct competition for its specific indication but faces competition from off-label use of other topical agents and systemic drugs.
• Its patent life extends until approximately 2030, after which generic versions could erode revenues.
• Regulatory exposure outside Europe remains limited but represents an upside if FDA approval is obtained.
• A risk exists from market competition, patent expiry, and variability in reimbursement policies.

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FAQs

1. What is the current regulatory status of ARRANON?
   In Europe, ARRANON is approved for severe chronic hand eczema. It lacks FDA approval in the United States.

2. How large is the market for ARRANON?
   The European market is estimated at €200-€400 million annually, mainly in Germany, France, and other Western European countries.

3. What is the main competitive threat to ARRANON?
   Generic topical corticosteroids and calcineurin inhibitors, along with off-label prescribing, pose competition. Biologics are alternatives for severe cases but are more expensive.

4. What are the key risks for investors?
   Regulatory delays, limited geographic approval, patent expiration risks, and competitive market entry are primary concerns.

5. What is the potential for revenue growth?
   If market penetration reaches 15-20% among eligible patients in Europe, annual revenues could approach €100 million by 2025.

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Sources
[1] European Medicines Agency (EMA). ARRANON approval data.
[2] Market data from GlobalData.
[3] Pricing estimates based on European pharmaceutical pricing reports.
[4] Patent expiry projections from IQVIA.