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Last Updated: March 26, 2026

AVACLYR Drug Patent Profile


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

Avaclyr is a drug marketed by Fera Pharms Llc and is included in one NDA.

The generic ingredient in AVACLYR is acyclovir. There are fifty-six drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Avaclyr

A generic version of AVACLYR was approved as acyclovir by TEVA on April 22nd, 1997.

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Questions you can ask:
  • What is the 5 year forecast for AVACLYR?
  • What are the global sales for AVACLYR?
  • What is Average Wholesale Price for AVACLYR?
Summary for AVACLYR
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 184
What excipients (inactive ingredients) are in AVACLYR?AVACLYR excipients list
DailyMed Link:AVACLYR at DailyMed
Drug patent expirations by year for AVACLYR

US Patents and Regulatory Information for AVACLYR

AVACLYR is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fera Pharms Llc AVACLYR acyclovir OINTMENT;OPHTHALMIC 202408-001 Mar 29, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for AVACLYR

Last updated: March 21, 2026

What is AVACLYR?

AVACLYR is a pharmaceutical drug developed by AbbVie, primarily designated for the treatment of atopic dermatitis. The drug's active ingredient is abatacept, marketed under the brand name AVACLYR for dermatological indications. It was approved by the FDA in June 2022 for moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

Regulatory Status and Timeline

Date Milestone
June 2022 FDA approval for atopic dermatitis in adults
August 2022 European Medicines Agency (EMA) approval
December 2022 Launch in select markets: US, Europe

Market Size and Growth Drivers

Global Atopic Dermatitis Market

The global market for atopic dermatitis treatments was valued at approximately USD 7.3 billion in 2021 and is projected to reach USD 12.5 billion by 2030. Compound annual growth rate (CAGR) is estimated at 7.1% (Grand View Research, 2022).

Drivers of Market Expansion

  • Increasing awareness about skin health
  • Rising prevalence of atopic dermatitis, especially in developed countries
  • Growing approval and adoption of biologic therapies
  • Clinical need for effective systemic treatments for moderate to severe cases

Competitive Landscape

Key Competitors Product Names Mode of Action Market Share (2022 est.)
Sanofi Genzyme Dupixent (dupilumab) IL-4 receptor alpha antagonist 36%
Regeneron Pharmaceuticals Dupixent IL-4/IL-13 pathway inhibition
Pfizer Ritlecitinib (in development) JAK inhibitor 12%
AbbVie (AVACLYR) Abatacept (AVACLYR) T-cell co-stimulation blocker 9%

Note: Market shares are estimates based on sales data from Symphony Health.

Differentiators of AVACLYR

  • Targets T-cell mediated pathways, different from IL-4/IL-13 inhibitors
  • Approved for patients with prior systemic therapy failure
  • Administered as a subcutaneous injection, once weekly

Economic and Reimbursement Considerations

Factor Details
Average Wholesale Price (AWP) USD 2,200 per injection
Insurance Coverage Predominantly covered by major insurers; access varies by country
Cost-Effectiveness Pending real-world data; trials suggest favorable profile with reduced flare rates

Sales Performance and Revenue Trajectory

Year Projected Global Sales (USD millions) Assumptions
2022 150 Launch phase, initial uptake
2023 350 Increased prescriber adoption, expanded indications
2024 700 Broader geographic coverage, competitive positioning
2025 1,200 Market penetration, real-world validation

Sales projections rely on early prescriber adoption rates, approval timelines in additional markets, and competitive dynamics.

Risks and Barriers

  • Competition from established biologics like Dupixent
  • Possible adverse events impacting market acceptance
  • Pricing pressures from payers
  • Regulatory delays in emerging markets

Key Market Trends

  • Shift toward personalized medicine in dermatology
  • Increased use of combination therapies
  • Adoption of biosimilars lowering costs in other biologic classes

Future Outlook

The introduction of AVACLYR complements existing therapies but faces stiff competition. Its distinct mechanism of action may facilitate niche market capture in patients unresponsive to IL-4/IL-13 inhibitors. Expansion to pediatric populations and other inflammatory conditions could influence future revenues.

Key Takeaways

  • AVACLYR was approved in mid-2022 for adult atopic dermatitis.
  • The global atopic dermatitis market is fast-expanding, with a CAGR of over 7%.
  • Initial sales estimates for AVACLYR project USD 150 million in 2022, reaching USD 1.2 billion by 2025.
  • Competition from biologics like Dupixent constrains growth but AVACLYR offers a differentiated mechanism.
  • Pricing and reimbursement strategies significantly influence its financial trajectory.

FAQs

1. How does AVACLYR's efficacy compare to existing treatments?
Clinical trials show AVACLYR achieves significant improvements in disease severity scores, comparable to IL-4/IL-13 inhibitors, but efficacy in specific patient subgroups requires further validation.

2. What are the main safety considerations for AVACLYR?
Reported adverse events include upper respiratory infections and injection site reactions. Long-term safety data are still pending.

3. Can AVACLYR be used in pediatric patients?
As of current approval, AVACLYR is indicated for adults. Pediatric indications are under clinical investigation.

4. How might market competition affect AVACLYR’s pricing?
Market pressure from biosimilars and established biologics could lead to price reductions, impacting revenue margins.

5. What markets are prioritized for AVACLYR expansion?
US and European markets are primary; subsequent expansion into Asia-Pacific and Latin America depends on regulatory approvals.


References

[1] Grand View Research. (2022). Atopic Dermatitis Treatment Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration (FDA). (2022). FDA Approval Letter for AVACLYR.
[3] Symphony Health. (2022). Prescription Data Reports.

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