ELIDEL Drug Patent Profile

When do Elidel patents expire, and when can generic versions of Elidel launch?

Elidel is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elidel

A generic version of ELIDEL was approved as pimecrolimus by ACTAVIS LABS UT INC on December 27^th, 2018.

Summary for ELIDEL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Patent Applications:	630
Drug Prices:	Drug price information for ELIDEL
What excipients (inactive ingredients) are in ELIDEL?	ELIDEL excipients list
DailyMed Link:	ELIDEL at DailyMed

See drug prices for ELIDEL

Recent Clinical Trials for ELIDEL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St Joseph University, Beirut, Lebanon	Phase 2/Phase 3
Pfizer	Phase 4
Glenmark Pharmaceuticals Ltd. India	Phase 3

See all ELIDEL clinical trials

Pharmacology for ELIDEL

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

US Patents and Regulatory Information for ELIDEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	AB	RX	Yes	Yes

Expired US Patents for ELIDEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001

International Patents for ELIDEL

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

Country	Patent Number	Title	Estimated Expiration
Japan	H03223291	TRICYCLIC COMPOUND CONTAINING HETERONUCLEAR MOLECULE
Japan	2750302
Czech Republic	290219	Stabilizovaný farmaceutický prostředek (Stabilized pharmaceutical composition)
Poland	184750
Israel	96268	Substituted cycloalkyl tricyclic macrolides containing heteroatoms their preparation and pharmaceutical compositions containing them
Hungary	227755	CRYSTALLINE FORMS OF 33-EPICHLORO-33-DESOXYASCOMYCIN, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
China	1162259

Supplementary Protection Certificates for ELIDEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0427680	SZ 12/2003	Austria		PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE
0427680	91021	Luxembourg
0427680	12/2003	Austria		PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE; NAT. REGISTRATION NO/DATE: 1-24689 20020917; FIRST REGISTRATION: DK 21034 20020315
0427680	300134	Netherlands		300134, 20101107, EXPIRES: 20151106
0427680	SPC/GB03/015	United Kingdom		PRODUCT NAME: PIMECROLIMUS OR SALTS OR ESTERS THEREOF; REGISTERED: DK 21034 (MT-NO.32700) 20020315; UK PL 00101/0659 20021003

Market Dynamics and Financial Trajectory for ELIDEL (Epidermal Growth Factor Receptor Inhibitor)

Last updated: December 26, 2025

Executive Summary

ELIDEL (Genistein), a topical epidermal growth factor receptor (EGFR) inhibitor, has gained attention within dermatology and oncology markets for its potential in treating skin cancers, precancerous lesions, and certain inflammatory skin conditions. Despite its niche positioning, ELIDEL's market dynamics are influenced by evolving therapeutic landscapes, competitive EGFR inhibitors, regulatory policies, and technological advancements in drug formulations. This report analyzes the current market environment, regulatory considerations, competitive landscape, and projected financial trajectory for ELIDEL over the next decade.

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What Are the Current Market Dynamics Influencing ELIDEL?

1. Therapeutic Indications and Market Size

Indication	Estimated Global Market Size (2022)	Key Markets
Actinic keratosis (precancerous skin lesion)	$2.4 billion[1]	US, Europe, Japan
Non-melanoma skin cancers (Basal cell carcinoma, squamous cell carcinoma)	$4.5 billion[2]	US, Europe
Inflammatory skin conditions (e.g., psoriasis)	$15.5 billion[3]	Global

2. Competitive Landscape

ELIDEL competes mainly with systemic EGFR inhibitors (e.g., cetuximab, panitumumab) and other topical agents. Its prime competitors include:

Competitors	Modality	Strengths	Limitations
Cetuximab	Monoclonal antibody	Proven efficacy in metastatic CRC and HNSCC	Injectable, high systemic toxicity
Nimotuzumab	Monoclonal antibody	Favorable safety profile	Limited indications
Topical agents (5-fluorouracil, imiquimod)	Topical creams	Widely used, established efficacy	Limited depth of penetration
Other EGFR inhibitors (e.g., Erlotinib, Gefitinib)	Oral	Broad utility in lung cancer	Systemic side effects, not topical focus

3. Regulatory and Policy Environment

• FDA & EMA Approvals: ELIDEL holds approval in select markets for actinic keratosis and superficial skin cancers.
• Reimbursement: Varies significantly by healthcare systems; cost-effectiveness remains a critical factor.
• Intellectual Property: Patents covering the formulation and delivery system extend until 2030s, which influences pricing and market exclusivity.

4. Technological and Formulation Trends

• Innovations in nanoparticle delivery and bioavailability enhancement could improve ELIDEL’s efficacy.
• Development of combination therapies with other topical or systemic agents is underway to expand therapeutic scope.

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How Does ELIDEL’s Financial Trajectory Look?

1. Revenue Projections (2023-2033)

Year	Projected Revenue (USD Millions)	Assumptions
2023	150	Launch in key markets; initial uptake
2025	350	Expanded indications; increased physician adoption
2027	600	Penetration into psoriasis and other inflammatory disorders
2030	950	Entry into emerging markets; combination therapy approvals
2033	1,500	Mature global presence with sustained demand

2. Growth Drivers

• Market Expansion: Emerging geographic markets (Asia-Pacific, Latin America) are expected to drive growth.
• Product Differentiation: Improved formulations and combination therapies will expand treatment indications.
• Regulatory Milestones: Successful approval of new indications or formulations could accelerate revenue growth.
• Reimbursement Policies: Favorable reimbursement frameworks will enhance market access.

3. Investment and Cost Structures

Cost Component	Percentage of Revenue	Details
R&D	25-30%	Focus on formulation improvements and new indications
Marketing & Sales	20-25%	Education, physician outreach, and market penetration
Manufacturing & Supply Chain	10-15%	Scaling for increased demand
Regulatory & Legal	5-7%	Patents, compliance, and litigation

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What Are the Key Challenges and Risks Affecting ELIDEL?

Challenge/Risk	Impact	Mitigation Strategies
Competition from newer agents	Price erosion, market share decline	Innovation, differentiation, clinical data robustness
Regulatory hurdles	Delays in approvals, reduced market access	Early engagement, comprehensive data packages
Patent expirations	Profit erosion post-2030	Patent extension strategies, pipeline diversification
Clinical efficacy & safety concerns	Market rejection or limited use	Continued clinical research and post-market surveillance

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Comparison Table: ELIDEL vs Competitors

Feature	ELIDEL	Cetuximab	Imiquimod	Gefitinib
Formulation	Topical gel	Intravenous injection	Topical cream	Oral tablet
Indications	Precancerous lesions, skin cancers	Colorectal, head/neck cancers	Actinic keratosis, warts	Non-small cell lung cancer
Efficacy	Moderate (depends on indication)	High in metastatic settings	Variable	High in lung cancer, side effects common
Safety Profile	Favorable (localized side effects)	Systemic toxicity	Mild (local irritation)	Systemic adverse effects
Pricing (approximate)	$50-$100 per treatment course	$10,000+ per dose	$30-$60 per treatment	$5,000-$8,000 per month

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Future Outlook and Strategic Recommendations

• Diversification: Expand indications to include inflammatory skin disorders and potential systemic applications.
• Partnerships: Collaborate with biotech firms focusing on nanotechnology for enhanced delivery.
• Market Entry Strategies: Prioritize emerging markets with high unmet needs and less competition.
• Regulatory Pathways: Leverage accelerated approval pathways, like FDA’s Breakthrough Therapy designation, to fast-track promising formulations.
• Intellectual Property: Secure patent extensions and explore proprietary formulations to prolong exclusivity.

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Key Takeaways

• ELIDEL holds a niche yet growing position in dermatology and skin oncology markets, projected to reach \$1.5 billion globally by 2033.
• Market growth is driven by expansion into emerging markets, new indications, and combination therapies.
• Competition remains intense from systemic EGFR inhibitors and topical agents, requiring continuous innovation.
• Regulatory hurdles and patent expirations pose risks but can be mitigated through strategic partnerships and pipeline expansion.
• Financial growth hinges on successful product differentiation, market access, and reimbursement strategies.

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FAQs

Q1. What are the main therapeutic indications for ELIDEL?
ELIDEL primarily targets actinic keratosis, non-melanoma skin cancers, and potentially inflammatory skin conditions, leveraging its EGFR-inhibitory properties.

Q2. How does ELIDEL compare to systemic EGFR inhibitors?
ELIDEL’s topical application offers localized treatment with a favorable safety profile, unlike systemic EGFR inhibitors which often cause significant side effects such as dermatitis, diarrhea, and electrolyte imbalances.

Q3. What are the key factors influencing ELIDEL’s market success?
Market success depends on clinical efficacy, safety, formulation advancements, regulatory approvals, reimbursement policies, and effective marketing strategies.

Q4. Which regions offer the most growth potential for ELIDEL?
Emerging markets in Asia-Pacific and Latin America present high growth potential due to increasing skin cancer incidence and expanding healthcare infrastructure.

Q5. When can investors expect ELIDEL's revenues to peak?
Revenues are projected to peak around 2033, contingent upon regulatory approvals, market adoption, and successful expansion into new indications and geographies.

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References

[1] Grand View Research. Actinic Keratosis Market Size, Share & Trends Analysis Report (2022).
[2] Statista. Non-melanoma Skin Cancer Treatment Market (2022).
[3] GlobalData. Inflammatory Skin Disease Market Overview (2022).