When will the ADBRY patents expire, and when will biosimilar ADBRY be available?

Last updated: September 8, 2026

Adbry, known as Adtralza outside the United States, is LEO Pharma's biologic treatment for moderate-to-severe atopic dermatitis. Its active ingredient, tralokinumab-ldrm, is a selective interleukin-13 inhibitor. The product has established a commercial position in dermatology but remains a challenger to Dupixent, the dominant biologic in atopic dermatitis.

LEO's reported Adtralza sales increased from approximately DKK 0.2 billion in 2021 to about DKK 1.0 billion in 2023. Growth has been driven by broader regulatory approvals, payer access, physician familiarity with IL-13 inhibition and expansion in European markets. The main commercial constraints are Dupixent's entrenched position, newer IL-13 competitors, reimbursement controls and LEO's limited scale relative to Sanofi and other large pharmaceutical companies.

How large is the Adbry and Adtralza market?

The addressable market is the moderate-to-severe atopic dermatitis population requiring systemic therapy or advanced biologic treatment. The market includes adults, adolescents and, in some jurisdictions, children.

Atopic dermatitis biologics compete with:

Dupixent, or dupilumab, from Sanofi and Regeneron
Adbry and Adtralza, or tralokinumab, from LEO Pharma
Ebglyss, or lebrikizumab, from Almirall and Eli Lilly in selected markets
JAK inhibitors, including Rinvoq and Cibinqo
Conventional systemic immunosuppressants and phototherapy

Dupixent remains the category leader because it entered the market earlier, has broad label coverage, has accumulated substantial clinical experience and is approved across several type 2 inflammatory diseases. Adbry's commercial opportunity depends on obtaining share from Dupixent and capturing patients who need an IL-13-selective mechanism.

What is Adbry's approved indication?

The FDA approved Adbry in December 2021 for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with prescription topical therapies or when those therapies are not advisable. The FDA later expanded the indication to adolescents aged 12 to 17. Adbry is used with or without topical corticosteroids. [1]

European approval for Adtralza covers moderate-to-severe atopic dermatitis in eligible patients who are candidates for systemic therapy. The European label has expanded beyond the original adult population in certain jurisdictions. [2]

How does tralokinumab work?

Tralokinumab binds to interleukin-13 and prevents signaling through the IL-13 receptor pathway. Dupilumab blocks the shared IL-4 receptor alpha pathway and inhibits signaling from both IL-4 and IL-13.

The distinction gives Adbry a narrower mechanism than Dupixent. Its commercial value depends on whether physicians view selective IL-13 inhibition as clinically differentiated or as broadly interchangeable with other type 2 biologics.

What are Adbry's reported sales and financial trajectory?

LEO Pharma reports Adtralza and Adbry sales as a global product line rather than consistently separating United States and international revenue. The following figures use LEO's reported annual-report data and rounded values.

Fiscal year	Reported Adtralza/Adbry sales	Approximate growth	Commercial status
2021	DKK 0.2 billion	Initial launch year	U.S. approval in December
2022	DKK 0.6 billion	More than 200% from a small base	European and U.S. market expansion
2023	DKK 1.0 billion	Approximately 60% to 70%	Broader prescriber and payer penetration

Sources: LEO Pharma annual reports for 2021, 2022 and 2023. [3-5]

The trajectory shows successful launch execution, but the product remains materially smaller than Dupixent. The increase from roughly DKK 0.2 billion in 2021 to roughly DKK 1.0 billion in 2023 represents a strong compound growth rate from a low base. It does not establish that Adbry has become a category leader.

What is driving Adbry revenue growth?

Revenue growth has four main drivers:

Geographic expansion. LEO has launched Adtralza across European markets and Adbry in the United States.
Label expansion. Approval in adolescents increases the eligible patient pool and supports earlier treatment in the disease course.
Reimbursement access. Coverage decisions determine whether the product can compete with Dupixent in routine prescribing.
Repeat treatment revenue. Atopic dermatitis is chronic, so persistent patients generate recurring biologic sales when they remain on therapy.

LEO's commercial model benefits from chronic use, but persistence is affected by response rates, injection burden, payer switching and physician preference.

Is Adbry commercially profitable for LEO Pharma?

Public reporting does not provide a complete product-level profit-and-loss statement for Adbry. Product revenue is visible, but manufacturing costs, launch expenses, sales-force investment, royalties and allocated corporate costs are not disclosed at the product level.

The economic profile is likely improving as sales scale. Biologic products typically have high gross margins after manufacturing capacity is established, but Adbry's profitability is reduced by:

Commercial launch spending
Medical-affairs and market-access costs
Manufacturing and cold-chain requirements
Licensing obligations associated with the AstraZeneca transaction
Rebates and discounts paid to U.S. commercial and government payers

Adbry's strategic importance is greater than its current sales contribution because it is one of LEO's principal growth products. LEO has described Adtralza as a key driver of sales growth and a central asset in its dermatology portfolio. [3-5]

How does Adbry compare with Dupixent and other biologics?

Attribute	Adbry/Adtralza	Dupixent	Ebglyss
Active ingredient	Tralokinumab	Dupilumab	Lebrikizumab
Primary target	IL-13	IL-4 receptor alpha, blocking IL-4 and IL-13 signaling	IL-13
Originator	LEO Pharma, licensed from AstraZeneca	Sanofi and Regeneron	Almirall and Eli Lilly
Main dermatology use	Moderate-to-severe atopic dermatitis	Moderate-to-severe atopic dermatitis and other type 2 diseases	Moderate-to-severe atopic dermatitis
Dosing profile	Loading dose followed by subcutaneous maintenance dosing; some patients may use less frequent maintenance dosing	Loading dose followed by maintenance dosing, with schedules varying by age and indication	Loading dose followed by maintenance dosing
Commercial position	Challenger	Category leader	Newer IL-13 competitor

Dupixent has the strongest commercial position because it has broader indications, greater physician familiarity and a larger established patient base. Adbry's direct mechanistic comparison is strongest against Ebglyss, since both selectively inhibit IL-13. In that comparison, dosing interval, speed of response, safety, formulary status and net price are likely to determine prescribing more than mechanism alone.

What is the FDA regulatory status of Adbry?

The FDA approved Adbry under the biologics license application pathway. Key regulatory milestones include:

Date	Milestone
December 27, 2021	FDA approval for adults with moderate-to-severe atopic dermatitis
2023	FDA expansion to adolescents aged 12 to 17
Ongoing	Postmarketing obligations and label-based pharmacovigilance

The FDA prescribing information identifies conjunctivitis and injection-site reactions among important adverse events. The label also includes warnings concerning hypersensitivity, helminth infections and live vaccines. [1]

Adbry is administered by subcutaneous injection. It is not a small-molecule drug and therefore is not exposed to a conventional Abbreviated New Drug Application generic-launch pathway.

What is the Orange Book status of Adbry?

Adbry is a biologic and is not generally evaluated through the small-molecule Orange Book framework. Biologic reference products are tracked through the FDA Purple Book, and follow-on competition is governed by the Biologics Price Competition and Innovation Act.

The distinction matters commercially:

A generic drug can often rely on an Orange Book-listed patent certification.
A biosimilar applicant follows a biologics license application pathway under section 351(k) of the Public Health Service Act.
Interchangeability requires a separate FDA determination.
Patent disputes may proceed under the BPCIA patent-exchange process rather than a conventional Hatch-Waxman Paragraph IV filing.

Are there Paragraph IV challenges to Adbry?

No material public Paragraph IV challenge is central to Adbry's current commercial outlook because Adbry is a biologic rather than a conventional small-molecule product.

A biosimilar developer could still challenge tralokinumab-related patents or seek a license before launch. The relevant risks would include:

Patent litigation under the BPCIA
Patent-validity and infringement disputes
FDA exclusivity timing
Manufacturing comparability
Reference-product exclusivity
Interchangeability and payer substitution decisions

The absence of a conventional Paragraph IV event does not eliminate future entry risk. It changes the legal route and usually lengthens the development and launch process relative to a small-molecule generic.

What patents and exclusivity rights protect Adbry?

Adbry's protection comes from a combination of biologic regulatory exclusivity, antibody-related patent rights, formulation and manufacturing know-how, and potentially method-of-use claims.

The commercially important protection categories are:

Composition-of-matter and antibody patents

These claims may cover the tralokinumab antibody, antibody sequences, binding characteristics or functional activity against IL-13. Such patents are generally more valuable than narrow treatment-method claims because they can reach the product itself.

Formulation patents

Formulation claims may cover protein concentration, stabilizers, buffers, excipients, pH ranges, storage conditions or prefilled delivery systems. Their value depends on whether a biosimilar developer can use a different formulation without sacrificing stability or substituting a non-infringing presentation.

Method-of-use patents

Method claims may cover treatment of atopic dermatitis, dosing schedules, patient populations or combination use with topical corticosteroids. These claims can support litigation but may be easier to design around than composition claims.

Manufacturing and process protection

Manufacturing know-how can cover cell lines, expression systems, purification, viral clearance, aggregation control and fill-finish processes. Process barriers can delay biosimilar development even where composition patents are weak, but trade secrets are difficult to enforce against an independently developed process.

Regulatory exclusivity

Biologic exclusivity is separate from patent exclusivity. FDA reference-product exclusivity generally provides a period during which a biosimilar application cannot be approved, subject to the statutory framework and applicable regulatory interpretation. Patent expiration dates may extend beyond the regulatory exclusivity period.

A precise patent-expiration analysis requires a current FDA Purple Book review and jurisdiction-specific patent-family analysis. Public product-level disclosures do not establish a single global loss-of-exclusivity date for Adbry.

When does Adbry lose exclusivity?

Adbry does not have one universal loss-of-exclusivity date. The timing depends on:

U.S. biologic regulatory exclusivity
Patent-family expiration dates
Patent-term adjustments or extensions
Continuation applications
Litigation outcomes
Biosimilar development timelines
National patent rights outside the United States

In the United States, biosimilar competition is unlikely to resemble an immediate generic cliff. A potential entrant must develop a comparable biologic, generate analytical and clinical evidence, satisfy FDA requirements and manage patent litigation. This creates a staged risk profile:

Period	Primary risk
Near term	Payer pressure, formulary competition and share loss to newer biologics
Medium term	Biosimilar development and patent litigation
Longer term	Multiple biosimilar entrants, price erosion and interchangeability pressure

The more immediate commercial threat is branded competition rather than biosimilar substitution.

What licensing deal created LEO's rights to tralokinumab?

LEO Pharma obtained rights to develop and commercialize tralokinumab in dermatology through an agreement with AstraZeneca. The transaction transferred dermatology commercialization responsibility to LEO while allowing AstraZeneca to retain economics through upfront, milestone and royalty arrangements described in the transaction announcement. [6]

The license structure has two financial effects:

LEO controls commercial execution and captures product revenue.
LEO's net economics are reduced by contractual payments and development obligations.

The arrangement gave LEO access to a late-stage biologic without bearing the full cost of originating the antibody program. It also created dependence on an externally sourced asset for a major portion of future dermatology growth.

Which companies are challenging Adbry's market position?

Adbry faces competition from several groups.

Sanofi and Regeneron

Dupixent is the principal incumbent. Its broader inflammatory-disease franchise supports payer negotiations, physician adoption and patient retention. Dupixent's scale also gives the manufacturers more resources for clinical studies and indication expansion.

Almirall and Eli Lilly

Ebglyss is the closest mechanistic competitor because it also targets IL-13. Its launch increases pressure on Adbry in patients and physicians seeking selective IL-13 inhibition.

AbbVie

Rinvoq competes for patients requiring systemic treatment. Its oral administration is attractive to some patients, although JAK inhibitor safety considerations and regulatory warnings affect use.

Pfizer

Cibinqo is another oral systemic competitor. Its commercial performance depends on treatment sequencing, payer restrictions and the balance between oral convenience and safety monitoring.

Biosimilar developers

Biosimilar companies are not yet the main source of Adbry pressure, but they could become relevant after sufficient commercial value and a clearer patent pathway develop.

What is the generic and biosimilar launch risk for Adbry?

The risk of a near-term conventional generic launch is effectively absent because tralokinumab is a biologic. The longer-term biosimilar risk is real but likely to develop gradually.

A biosimilar entrant would need to overcome:

Complex antibody characterization
Cell-line and manufacturing requirements
Clinical or pharmacologic comparability expectations
Patent disputes
Reference-product exclusivity
Physician and payer adoption barriers
Possible switching concerns

Biosimilar price erosion could be less severe initially than small-molecule generic erosion. The first entrant may obtain a discount without triggering automatic substitution. Greater erosion becomes more likely if several biosimilars enter and an interchangeable product receives favorable payer treatment.

How strong is the Adbry patent estate?

The commercial patent estate appears more valuable as a layered protection system than as a single patent barrier. Its strength depends on whether LEO and its partners hold enforceable claims covering the antibody, clinically relevant formulations and commercially used manufacturing processes.

Patent strength is highest when:

Core antibody claims remain unexpired
Claims cover the marketed molecule rather than only a narrow use
Formulation claims correspond to the commercial presentation
Manufacturing claims are difficult to design around
The product has strong regulatory and market exclusivity in parallel

Patent strength is weaker when protection rests mainly on dosing or treatment-method claims that a biosimilar developer can avoid. The most important practical question is whether a biosimilar can launch with a non-infringing formulation and manufacturing process after regulatory exclusivity ends.

What is the commercial outlook for Adbry?

Adbry has a credible growth path, but its ceiling is constrained by category competition. The product can continue to grow if LEO expands access, improves persistence, demonstrates differentiated outcomes and secures favorable positioning after Dupixent.

The principal upside factors are:

Additional pediatric label expansion
Stronger U.S. reimbursement
Increased use after topical therapy failure
Physician adoption of IL-13-selective treatment
Less frequent maintenance dosing for appropriate patients
Growth in European markets
Positive real-world persistence data

The main downside factors are:

Dupixent's entrenched first-line biologic position
Ebglyss competition in the same mechanism class
Oral JAK inhibitor convenience
Payer-mandated step therapy
LEO's smaller commercial infrastructure
Royalty and launch-cost pressure
Future biosimilar competition

Adbry's financial trajectory is therefore more likely to be a sustained-growth profile than a rapid category takeover. The product has moved from launch-stage revenue to a meaningful LEO growth asset, but it remains exposed to share competition and reimbursement economics.

Key Takeaways

Adbry is LEO Pharma's U.S. brand for tralokinumab-ldrm; Adtralza is the primary international brand.
Reported global sales increased from approximately DKK 0.2 billion in 2021 to about DKK 1.0 billion in 2023.
Dupixent is the dominant competitor and has major advantages in scale, indications and physician familiarity.
Ebglyss is the closest branded mechanistic competitor because it also selectively inhibits IL-13.
Adbry is a biologic, so conventional Orange Book and Paragraph IV generic challenges are not the primary framework.
Future entry risk will arise through biosimilar development, BPCIA litigation and patent expiry.
LEO's economics are affected by the AstraZeneca licensing arrangement, launch investment, rebates and manufacturing costs.
The near-term commercial threat is branded competition and payer access, not a generic cliff.
Adbry's patent protection is likely to depend on the combined strength of antibody, formulation, method-of-use and manufacturing rights.
The product has a positive revenue trajectory but remains a challenger asset rather than a category leader.

FAQs About Adbry Market Dynamics

Is Adbry the same drug as Adtralza?

Yes. Adbry is the U.S. brand name for tralokinumab-ldrm. Adtralza is the brand name used in many markets outside the United States.

Is Adbry a biosimilar?

No. Adbry is the reference biologic product containing tralokinumab-ldrm. A future tralokinumab biosimilar would require separate FDA approval.

Does Adbry compete directly with Dupixent?

Yes. Both are used for moderate-to-severe atopic dermatitis, but tralokinumab selectively targets IL-13 while dupilumab blocks IL-4 receptor alpha signaling associated with both IL-4 and IL-13.

Can Adbry be substituted automatically at the pharmacy?

Automatic substitution depends on FDA interchangeability status, state law, payer policy and product-specific regulatory determinations. Biologic substitution is not governed by the same rules as ordinary generic substitution.

Is Adbry protected by an Orange Book patent?

Adbry is a biologic, so the principal U.S. regulatory and patent framework is the Purple Book and the BPCIA rather than the traditional Orange Book generic framework.

References

U.S. Food and Drug Administration. (2023). Adbry (tralokinumab-ldrm) prescribing information.
European Medicines Agency. (2023). Adtralza: EPAR product information.
LEO Pharma A/S. (2021). Annual report 2021.
LEO Pharma A/S. (2022). Annual report 2022.
LEO Pharma A/S. (2023). Annual report 2023.
AstraZeneca. (2016). AstraZeneca and LEO Pharma enter agreement for tralokinumab in dermatology.

Mechanism of Action	Interleukin-13 Antagonists
Established Pharmacologic Class	Interleukin-13 Antagonist

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Summary for Tradename: ADBRY

Pharmacology for ADBRY

Note on Biologic Patents

1) High Certainty: US Patents for ADBRY Derived from Brand-Side Litigation

2) High Certainty: US Patents for ADBRY Derived from DrugPatentWatch Analysis and Company Disclosures

3) Low Certainty: US Patents for ADBRY Derived from Patent Text Search