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:	50
Clinical Trials:	39
Patent Applications:	532
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	6,423,722*PED
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	5,912,238*PED
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	6,352,998*PED

International Patents for ELIDEL

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

Country	Patent Number	Title	Estimated Expiration
Austria	299017
Canada	2290412	MACROLIDES CRISTALLINS ET PROCEDE DE PREPARATION ASSOCIE (CRYSTALLINE MACROLIDES AND PROCESS FOR THEIR PREPARATION)
Denmark	0786986
Indonesia	24897
Netherlands	300134
Norway	312765
Slovakia	186699	CRYSTALLINE MACROLIDES AND PROCESS FOR THEIR PREPARATION

Supplementary Protection Certificates for ELIDEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	91021	Luxembourg
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
0427680	SZ 12/2003	Austria		PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE

Market Dynamics and Financial Trajectory for ELIDEL

Overview of ELIDEL

ELIDEL, also known as pimecrolimus cream, is a topical calcineurin inhibitor used as a second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children aged 2 years and older. Here’s a detailed look at its market dynamics and financial trajectory.

Market Segmentation and Competition

The global atopic dermatitis treatment market is segmented by drug class, with ELIDEL falling under the category of topical immunomodulators/topical calcineurin inhibitors, alongside other products like Protopic (tacrolimus)[1][4].

Competitive Landscape

ELIDEL competes with other topical treatments such as Protopic and newer therapies like PDE4 inhibitors (e.g., Eucrisa) and interleukin inhibitors (e.g., Dupixent). The market is highly competitive, with major players including AbbVie, Inc., Almirall, S.A., Bausch Health Companies, Inc., and Pfizer, Inc.[4].

Sales and Revenue

Historically, ELIDEL has generated significant revenue. For instance, in the US, Elidel Cream, 1% had annual sales of approximately $218.4 million as of October 2018[2].

Impact of Generic Versions

The launch of generic versions of ELIDEL has significantly impacted its sales. Teva Pharmaceuticals announced the US launch of a generic version of Elidel Cream, 1% in 2018, which has likely reduced the market share and revenue of the branded product[2].

Cost Effectiveness and Healthcare Impact

Cost Analysis

Studies have shown that while ELIDEL leads to an overall increase in costs, it also improves clinical outcomes. For example, a cost-effectiveness analysis in Canada indicated that the incremental cost per quality-adjusted life year (QALY) gained from using ELIDEL was around $35,000 to $38,000, which is considered cost-effective given previous funding decisions[3].

Clinical Outcomes

ELIDEL has been shown to improve clinical outcomes for patients with atopic dermatitis, although it comes with certain safety concerns such as the potential for skin papillomas and lymphadenopathy[5].

Market Growth and Forecast

Global Market Trends

The global atopic dermatitis treatment market is expected to grow significantly, driven by increasing prevalence, new product launches, and favorable reimbursement policies. However, the growth of ELIDEL specifically is expected to be impacted by the availability of generics and newer, more effective treatments like JAK inhibitors and interleukin inhibitors[1].

Geographic Performance

North America, particularly the US, has been a dominant region for the atopic dermatitis treatment market, including ELIDEL, due to higher treatment awareness and better reimbursement policies. However, generic erosion and poor patient compliance in some countries are expected to negatively impact the growth of branded products like ELIDEL[1].

Future Outlook

Pipeline and Emerging Therapies

The market is shifting towards newer therapies such as JAK inhibitors (e.g., Opzelura, Rinvoq) and interleukin inhibitors (e.g., Dupixent, Adbry), which are expected to capture a significant patient share due to their broader mechanism of action and ease of administration. This trend is likely to further reduce the market share of traditional topical treatments like ELIDEL[1].

Regulatory and Safety Considerations

The safety and efficacy of ELIDEL in immunocompromised patients have not been established, and there are warnings regarding long-term safety and potential adverse events such as skin papillomas and lymphadenopathy. These factors may influence prescribing decisions and impact the product's financial trajectory[5].

Key Takeaways

• Revenue Impact: ELIDEL has historically generated significant revenue but is expected to decline with the introduction of generic versions and newer therapies.
• Cost Effectiveness: Despite higher costs, ELIDEL improves clinical outcomes, making it a cost-effective option in certain healthcare systems.
• Market Competition: The market is highly competitive, with newer therapies like JAK and interleukin inhibitors gaining traction.
• Geographic Performance: North America remains a key market, but generic erosion and compliance issues affect growth.
• Future Outlook: The product's market share is expected to decline as newer, more effective treatments become available.

FAQs

What is ELIDEL used for?

ELIDEL (pimecrolimus cream) is used as a second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children aged 2 years and older.

How has the launch of generic versions affected ELIDEL's sales?

The launch of generic versions of ELIDEL has significantly reduced its sales and market share, as generic products are generally more affordable and equally effective.

What are the safety concerns associated with ELIDEL?

ELIDEL has safety concerns such as the potential for skin papillomas and lymphadenopathy. The long-term safety of topical calcineurin inhibitors like ELIDEL has not been established.

How does ELIDEL compare to newer therapies in terms of cost-effectiveness?

While ELIDEL improves clinical outcomes and is considered cost-effective in some healthcare systems, newer therapies like JAK and interleukin inhibitors offer broader mechanisms of action and ease of administration, potentially making them more favorable options.

What is the forecasted growth of the atopic dermatitis treatment market?

The global atopic dermatitis treatment market is expected to reach $31.7 billion by 2031, growing at a CAGR of 14.1%, driven by increasing prevalence, new product launches, and favorable reimbursement policies.

Sources

1. Global Atopic Dermatitis Treatment Market $31.7 Billion by 2031 - iHealthcareAnalyst
2. Teva Announces US Launch of a Generic Version of Elidel - Teva Pharmaceuticals
3. Cost effectiveness of Elidel in the management of patients - PubMed
4. Atopic Dermatitis (AD) Treatment Market and Forecast 2024-2031 - iHealthcareAnalyst
5. ELIDEL® (pimecrolimus) Cream, 1% for topical use - FDA Label