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Drug Price Trends for NDC 00904-7137
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Average Pharmacy Cost for 00904-7137
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NITROFURANTOIN MONO-MCR 100 MG | 00904-7137-61 | 0.33183 | EACH | 2026-03-18 |
| NITROFURANTOIN MONO-MCR 100 MG | 00904-7137-61 | 0.33520 | EACH | 2026-02-18 |
| NITROFURANTOIN MONO-MCR 100 MG | 00904-7137-61 | 0.34774 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-7137
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
AbbVie's Rinvoq (Upadacitinib) Patent Landscape and Market Outlook
This analysis examines the patent portfolio and market trajectory for AbbVie's Rinvoq (upadacitinib). Rinvoq, a selective JAK1 inhibitor, is approved for multiple inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, and ulcerative colitis. The drug's patent exclusivity is a critical factor influencing its market penetration and pricing dynamics.
What is the patent status for Rinvoq (upadacitinib)?
Rinvoq's primary composition of matter patent, U.S. Patent No. 9,428,483, was granted on August 30, 2016. This patent is set to expire on August 30, 2033. AbbVie has also secured secondary patents covering various aspects of upadacitinib, including specific polymorphs, salt forms, methods of treatment, and manufacturing processes.
These secondary patents extend the period of potential market exclusivity beyond the primary composition of matter patent. For instance, patents related to specific therapeutic uses for upadacitinib may offer protection for different indications for varying durations.
| Patent Number | Title | Expiration Date |
|---|---|---|
| U.S. Patent No. 9,428,483 | Pyridinone compounds and their use as JAK inhibitors | August 30, 2033 |
| U.S. Patent No. 10,774,006 | Pharmaceutical composition comprising a JAK inhibitor and a method for treating inflammatory conditions | July 7, 2035 |
| U.S. Patent No. 11,051,880 | Preparation of substituted pyridinone compounds | October 26, 2037 |
| U.S. Patent No. 11,629,285 | Method of treating rheumatoid arthritis with upadacitinib | September 28, 2038 |
These expiration dates represent the earliest potential market entry for generic competitors for each respective patent. However, the interplay of multiple patents and potential litigation can influence the actual timeline of generic competition. AbbVie actively defends its intellectual property, and challenges to its patents are anticipated.
What is the current market performance of Rinvoq?
Rinvoq has demonstrated significant market growth since its initial approval in August 2018. In 2023, AbbVie reported net revenues of $3.76 billion for Rinvoq, a substantial increase from $2.47 billion in 2022 and $1.29 billion in 2021. This growth is driven by label expansions into new indications and increasing market penetration in its existing therapeutic areas.
The drug's performance is particularly strong in the treatment of rheumatoid arthritis (RA) and atopic dermatitis (AD). In RA, Rinvoq competes with other JAK inhibitors and biologic DMARDs. In AD, it is positioned against other oral and injectable treatments.
| Year | Net Revenues (USD billions) |
|---|---|
| 2021 | 1.29 |
| 2022 | 2.47 |
| 2023 | 3.76 |
The increasing number of approved indications has been a key driver of this revenue growth. Rinvoq is currently approved in the U.S. for:
- Rheumatoid Arthritis (RA)
- Psoriatic Arthritis (PsA)
- Atopic Dermatitis (AD)
- Ankylosing Spondylitis (AS)
- Ulcerative Colitis (UC)
Each indication represents a distinct market segment with its own competitive landscape and patient population, contributing to Rinvoq's expanding commercial footprint.
What are the projected market trends for Rinvoq?
The market for Rinvoq is projected to continue its upward trajectory, fueled by ongoing label expansions and the increasing demand for effective treatments for chronic inflammatory diseases. Analysts forecast continued strong sales growth through the end of the patent protection period.
Key drivers for future market performance include:
- Further Indication Expansion: AbbVie is actively pursuing additional indications for upadacitinib, including Crohn's disease and other autoimmune conditions. Successful approvals in these areas will significantly broaden the drug's addressable market.
- Market Penetration in Existing Indications: As physician and patient awareness of Rinvoq's efficacy and safety profile grows, market share within approved indications is expected to increase.
- Competition Dynamics: While Rinvoq faces competition from other JAK inhibitors (e.g., Xeljanz, Olumiant) and biologics, its selective JAK1 inhibition profile is a key differentiator. The long-term patent exclusivity provides a significant competitive advantage.
However, the market is not without challenges. Regulatory scrutiny of JAK inhibitors, particularly concerning safety signals, could impact prescribing patterns. Furthermore, the eventual expiry of patents will open the door for generic competition, which will exert downward pressure on pricing.
What is the projected pricing and revenue outlook?
Rinvoq's pricing is reflective of its status as a novel, high-efficacy therapy for chronic conditions, with annual treatment costs often exceeding $60,000 USD. Pricing is influenced by clinical trial data, comparative effectiveness against existing treatments, and the perceived value proposition to patients and payers.
AbbVie's revenue from Rinvoq is projected to reach approximately $8-$10 billion annually in the coming years, before patent expiries significantly impact sales. The company's strategy involves maximizing revenue during the period of market exclusivity.
| Year (Projected) | Net Revenues (USD billions) |
|---|---|
| 2024 | 4.5 - 5.5 |
| 2025 | 5.5 - 6.5 |
| 2026 | 6.5 - 7.5 |
| 2027 | 7.5 - 8.5 |
Post-patent expiry, a significant decline in revenue is anticipated due to generic erosion, a common phenomenon in the pharmaceutical market. The precise timing and magnitude of this decline will depend on the speed of generic market entry and the pricing strategies of generic manufacturers.
What are the key competitive factors for Rinvoq?
Rinvoq operates within a highly competitive therapeutic landscape across its approved indications. Its primary competitors include other Janus kinase (JAK) inhibitors and a range of biologic disease-modifying antirheumatic drugs (bDMARDs).
JAK Inhibitor Competition:
- Tofacitinib (Xeljanz, Pfizer): Approved for RA, PsA, and UC. Tofacitinib was the first-in-class oral JAK inhibitor and holds significant market share.
- Baricitinib (Olumiant, Eli Lilly): Approved for RA and COVID-19. Eli Lilly is also seeking broader indications.
- Filgotinib (Jyseleca, Gilead Sciences): Approved in Europe for RA and UC, but its U.S. approval path has faced setbacks.
Biologic Competition:
- TNF Inhibitors: Adalimumab (Humira, AbbVie), Infliximab (Remicade, Janssen), Etanercept (Enbrel, Amgen). These have been the backbone of treatment for many inflammatory conditions for years.
- IL-17 Inhibitors: Secukinumab (Cosentyx, Novartis), Ixekizumab (Taltz, Eli Lilly). These are strong competitors, particularly in PsA and ankylosing spondylitis.
- IL-23 Inhibitors: Ustekinumab (Stelara, Janssen), Risankizumab (Skyrizi, AbbVie). These are gaining significant traction, especially in PsA and AD.
Rinvoq's competitive edge is its selective inhibition of JAK1, which AbbVie posits leads to a more favorable safety profile compared to non-selective JAK inhibitors, particularly regarding certain cardiovascular and thrombotic events. However, all JAK inhibitors are subject to ongoing safety reviews by regulatory agencies, which could influence their comparative positioning.
What is the regulatory outlook for Rinvoq?
The regulatory landscape for JAK inhibitors is evolving, with increased scrutiny from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding their safety profiles. Post-marketing studies and real-world evidence are continuously being evaluated.
In September 2021, the FDA issued a safety communication recommending limitations on JAK inhibitor use for certain patients and adding boxed warnings to their labels regarding increased risks of serious heart-related events, cancer, blood clots, and death. This has led to revised prescribing guidelines and a more cautious approach by some clinicians, particularly for patients at higher risk.
AbbVie has responded by emphasizing Rinvoq's selective JAK1 inhibition and presenting data that aims to differentiate its safety profile. The company continues to conduct post-marketing studies to further characterize the drug's risk-benefit profile.
Future regulatory decisions, particularly concerning any new indication approvals or safety updates, will significantly influence Rinvoq's market access and physician prescribing habits.
Key Takeaways
- Rinvoq's primary composition of matter patent expires in August 2033, with secondary patents extending protection to 2037 and 2038 for specific applications.
- The drug has achieved substantial market growth, with 2023 net revenues reaching $3.76 billion, driven by label expansions into multiple inflammatory conditions.
- Future market projections indicate continued strong revenue growth, potentially exceeding $8 billion annually before patent expiry, supported by ongoing indication expansion and market penetration.
- Rinvoq faces significant competition from other JAK inhibitors and a broad range of biologic therapies, with its selective JAK1 inhibition serving as a key differentiation.
- The regulatory environment for JAK inhibitors is increasingly cautious, with boxed warnings in place due to safety concerns, necessitating ongoing risk-benefit evaluations.
FAQs
-
When can generic versions of Rinvoq be launched in the United States? Generic entry is anticipated after the expiry of the relevant patents, with the earliest potential being for the primary composition of matter patent in August 2033. However, secondary patents may delay full generic market penetration.
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What are the main safety concerns associated with JAK inhibitors like Rinvoq? Regulatory agencies have highlighted increased risks of serious heart-related events, cancer, blood clots, and death associated with JAK inhibitors. Specific warnings are included in prescribing information.
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Which new indications is AbbVie seeking for Rinvoq? AbbVie is pursuing approvals for additional inflammatory conditions, including Crohn's disease and other autoimmune disorders, to further expand the drug's market reach.
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How does Rinvoq's pricing compare to other treatments for rheumatoid arthritis? Rinvoq is positioned as a premium therapy with annual costs typically exceeding $60,000, similar to other novel biologics and JAK inhibitors in the RA market.
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What is the impact of AbbVie's other blockbuster drug, Humira, on Rinvoq's market strategy? With Humira facing biosimilar competition, AbbVie is strategically pivoting to newer assets like Rinvoq and Skyrizi to drive future growth. Rinvoq's expansion into indications previously dominated by biologics like Humira is a key part of this strategy.
Citations
[1] U.S. Patent No. 9,428,483. (2016). Pyridinone compounds and their use as JAK inhibitors. United States Patent and Trademark Office. [2] U.S. Patent No. 10,774,006. (2020). Pharmaceutical composition comprising a JAK inhibitor and a method for treating inflammatory conditions. United States Patent and Trademark Office. [3] U.S. Patent No. 11,051,880. (2021). Preparation of substituted pyridinone compounds. United States Patent and Trademark Office. [4] U.S. Patent No. 11,629,285. (2023). Method of treating rheumatoid arthritis with upadacitinib. United States Patent and Trademark Office. [5] AbbVie Inc. (2024). AbbVie Reports Fourth Quarter and Full Year 2023 Results. [Press release]. [6] U.S. Food and Drug Administration. (2021, September 1). FDA adds boxed warning, other safety changes to JAK inhibitors. FDA.gov.
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