Last updated: February 17, 2026
What is NDC 00115-1436?
NDC 00115-1436 refers to a specific pharmaceutical product listed in the National Drug Code database. The product corresponds to AbbVie’s Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor approved in 2019 for the treatment of moderate to severe rheumatoid arthritis (RA). It has indications beyond RA, including psoriatic arthritis and ankylosing spondylitis.
What is the Current Market Size for Upadacitinib?
Market Penetration & Annual Sales
- 2022: Estimated global sales of Rinvoq exceeded $1 billion, with US sales accounting for roughly 70% of total revenue ($700 million).
- Market share: Rinvoq held 9% of the global oral JAK inhibitor market in 2022, behind Pfizer’s Xeljanz (16%) and Eli Lilly’s Olumiant (7%).
- Growth trend: The RA market is projected to expand at a CAGR of 6-8% through 2028, driven by increasing prevalence and expanded indications.
Target Conditions and Patient Population
- Rheumatoid arthritis: U.S. prevalence ~1.3 million, with 30-40% classified as moderate-to-severe.
- Other disorders: Psoriatic arthritis (~1 million), ankylosing spondylitis (~300,000), expanding indications.
- Treatment landscape: Competitive with biologic DMARDs such as adalimumab (Humira), etanercept, and other JAK inhibitors.
What Are Current Pricing Strategies and Reimbursement Policies?
Pricing and List Price
- US: The average wholesale price (AWP) for Rinvoq is estimated at $72,000 per year per patient, translating to roughly $6,000 per month.
- Discounts: Payers and pharmacy benefit managers negotiate rebates, bringing the actual net price lower.
- Comparison: This pricing is comparable to other oral JAK inhibitors (Xeljanz at $54,000 annually).
Reimbursement & Market Access
- Insurance coverage varies by insurer but generally covers Rinvoq as a second-line for RA after failure of methotrexate or other DMARDs.
- Patient assistance programs and copay cards influence market access and patient uptake, particularly in competitive markets.
What Are the Key Drivers of Future Price and Market Growth?
Indication Expansion
- Recent FDA approvals for pediatric RA and other autoimmune conditions expand the potential patient base.
- Ongoing clinical trials explore indications in atopic dermatitis and ulcerative colitis.
Patent and Competition Timeline
- Patent expiration: Patent for Rinvoq extends until at least 2030 in major markets.
- Competitors: Pfizer’s Xeljanz (approved since 2016); Eli Lilly’s Olumiant (approved since 2018) with similar indications.
Pricing Trends and Cost Pressures
- Search for value-based pricing models, with payers demanding outcomes-based reimbursements; this may decrease net prices over time.
- Generic or biosimilar competition unlikely until at least late 2020s due to newer molecular structure and patent protection.
What are Price Projections for 2023-2028?
| Year |
Estimated List Price (USD/year) |
Market Penetration |
Notes |
| 2023 |
$72,000 |
12–15% of targeted RA patients |
Slight increases due to inflation and indication expansion |
| 2024 |
$73,500 |
17–20% |
Entry into newer indications, increased generic competition in other JAKs |
| 2025 |
$75,000 |
20–25% |
Heightened emphasis on biosimilar entry and outcome-based pricing |
| 2026 |
$76,500 |
25–30% |
Saturation in developed markets, growth steady in emerging markets |
| 2027 |
$78,000 |
28–35% |
Potential price stabilization, increased biosimilar threats |
| 2028 |
$78,000 |
30–40% |
Market maturity, price adjustments possible across payers |
Key Market Risks and Opportunities
Risks
- Price erosion from biosimilars, biosimilar competitors for biologics, or future generics.
- Regulatory changes impacting reimbursement policies or indication approvals.
- Payer pressure on prices driven by cost-effectiveness assessment.
Opportunities
- Efficacy and safety profile may support premium pricing, especially with expanded indications.
- Durable patents and first-mover advantages in specific autoimmune disorders.
- Adoption of outcome-based pricing models could incentivize higher patient volumes.
Key Takeaways
- NDC 00115-1436 (Rinvoq) is a top-tier oral JAK inhibitor with a current list price of approximately $72,000 per year.
- The product’s market is expanding through new indications, with an estimated global sales exceeding $1 billion in 2022.
- Future market growth depends on indication expansion, competitive dynamics, and how payers negotiate prices.
- Price projections suggest slow increases up to $78,000 by 2028, with potential downward pressure from biosimilars.
- The competitive landscape will influence both market share and pricing strategies, especially as biosimilars and generics enter.
FAQs
1. When will Rinvoq face biosimilar competition?
Biosimilars targeting biologics used for RA may appear as early as the late 2020s, but biologics like Humira, before biosimilar integration, have taken up to 10 years to see significant generic entry.
2. How does Rinvoq’s price compare to biologic treatments?
Rinvoq’s annual cost (~$72,000) is comparable or slightly lower than biologic DMARDs like adalimumab ($60,000–$70,000), with oral administration offering a convenience advantage.
3. What are the key markets for expansion?
Emerging markets with rising autoimmune disease prevalence and healthcare infrastructure improvements are key targets, with regulatory approvals ongoing in multiple countries.
4. How might outcome-based reimbursement models impact pricing?
If payers adopt outcome-based contracts, prices could lower if desired health outcomes are not achieved, shifting risk to manufacturers.
5. Are there upcoming regulatory decisions that could influence the market?
Yes, additional approvals for Rinvoq in new indications or territories could boost sales and justify premium pricing strategies.
Sources
- IQVIA, U.S. Prescription Market Data, 2022
- FDA approval documents, Rinvoq, 2019
- EvaluatePharma, 2022 Global Sales Data for JAK inhibitors
- AeonRx, Market Reports on Rheumatoid Arthritis Drugs, 2023
- Centers for Disease Control and Prevention (CDC), RA Prevalence Data
