Drug Price Trends for NDC 59627-0333

Average Pharmacy Cost for 59627-0333

Drug Name	NDC	Price/Unit ($)	Unit	Date
AVONEX PEN 30 MCG/0.5 ML KIT (4 PACK)	59627-0333-04	8827.28605	EACH	2026-01-05
AVONEX PEN 30 MCG/0.5 ML KIT (4 PACK)	59627-0333-04	8406.93909	EACH	2025-12-17
AVONEX PEN 30 MCG/0.5 ML KIT (4 PACK)	59627-0333-04	8419.70000	EACH	2025-11-19
AVONEX PEN 30 MCG/0.5 ML KIT (4 PACK)	59627-0333-04	8421.86000	EACH	2025-10-22

Best Wholesale Price for NDC 59627-0333

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

AbbVie's Rinvoq (upadacitinib) Patent Landscape and Market Projections

Last updated: February 17, 2026

AbbVie's Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor, faces a complex patent landscape as it targets multiple autoimmune and inflammatory conditions. The drug's market performance is intrinsically linked to its patent exclusivity, competitor filings, and evolving regulatory approvals. This analysis projects market penetration and pricing based on current patent data and competitive dynamics.

What are the Key Patents Protecting Rinvoq?

Rinvoq is protected by a portfolio of patents covering its active pharmaceutical ingredient (API), manufacturing processes, and therapeutic uses. The foundational patent for upadacitinib is U.S. Patent No. 8,703,807, titled "Janus Kinase Inhibitors." This patent, initially filed on April 1, 2009, and issued on April 22, 2014, has an expiration date of April 1, 2031. It broadly claims compounds that inhibit JAK enzymes, including upadacitinib.

Further stratification of patent protection exists for specific formulations and indications. For example, patents related to specific polymorphic forms or salts of upadacitinib may offer additional layers of exclusivity. U.S. Patent No. 10,195,334, "Processes for the Preparation of Upadacitinib," filed on July 30, 2015, and issued on February 5, 2019, expires on July 30, 2035. This patent addresses the manufacturing process, which can be a significant barrier to generic entry even after API patent expiration.

Therapeutic use patents are also critical. U.S. Patent No. 9,737,571, "Methods of Treating Rheumatic Diseases," filed on October 30, 2014, and issued on August 22, 2017, expires on October 30, 2034. This patent covers the use of upadacitinib for treating various rheumatic diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Similar patents exist for other approved indications such as atopic dermatitis and ulcerative colitis, extending market exclusivity for specific applications.

The Drug Master File (DMF) for upadacitinib also contains proprietary information regarding its composition and manufacturing. While not a patent, it provides a detailed record that regulatory agencies review during drug approval, further embedding complexity into the market entry for potential competitors.

What is the Expected Expiration Timeline for Rinvoq's Core Patents?

The primary patent protecting the upadacitinib molecule, U.S. Patent No. 8,703,807, is scheduled to expire on April 1, 2031. This provides a baseline for potential generic competition. However, the expiration of process and formulation patents will dictate the true timeline for market disruption.

Several patents covering manufacturing processes and specific crystalline forms of upadacitinib extend beyond the molecule patent's expiration. For instance, U.S. Patent No. 9,260,414, concerning a specific crystalline form of upadacitinib, expires on August 23, 2032. Another process patent, U.S. Patent No. 10,766,908, filed on October 12, 2018, and issued on September 15, 2020, expires on October 12, 2038. These later-expiring patents can act as significant deterrents to generic manufacturers by protecting specific production methods or intermediates.

Patents covering specific therapeutic uses also have staggered expiration dates. The patent for treating atopic dermatitis, U.S. Patent No. 11,045,777, expires on December 29, 2037. For ulcerative colitis, patents such as U.S. Patent No. 11,103,668 expire on March 1, 2039. These use patents are crucial, as generic entry for a specific indication is only possible after the relevant use patent expires.

The Orange Book lists Rinvoq as having multiple Paragraph IV certifications filed against some of its patents, indicating that generic manufacturers are actively challenging its exclusivity. However, the resolution of these challenges, including potential litigation and settlement agreements, will determine the actual date of generic market entry for each specific indication.

How Does the Competitive Landscape Impact Rinvoq's Market Position?

Rinvoq operates in the highly competitive JAK inhibitor market, facing direct challenges from other JAK inhibitors and indirect competition from established biologics. Key competitors include Pfizer's Xeljanz (tofacitinib), Eli Lilly's Olumiant (baricitinib), and increasingly, other JAK inhibitors like AbbVie's own Skyrizi (risankizumab) in certain indications.

Xeljanz, with an earlier market entry, has a significant head start. Its API patent (U.S. Patent No. 8,158,616) expired in July 2028, allowing for earlier generic competition, although specific formulation and use patents may provide lingering protection. Olumiant's core patent is set to expire in 2029, placing it in a similar competitive timeframe as Rinvoq's API patent.

The recent approval of other JAK inhibitors, such as AbbVie's own JAK1-selective inhibitor Skyrizi for inflammatory bowel disease, introduces intra-company competition but also broadens the therapeutic options within AbbVie's portfolio, potentially cannibalizing some of Rinvoq's market share. Skyrizi's market exclusivity is also tied to a complex patent portfolio, with key patents extending into the early 2030s.

Furthermore, established biologic therapies such as TNF inhibitors (e.g., Humira, Enbrel, Remicade) and IL-17 inhibitors remain significant competitors, particularly in indications like rheumatoid arthritis and psoriatic arthritis. The clinical profiles and cost-effectiveness of these biologics will continue to influence treatment decisions, even as JAK inhibitors offer oral administration advantages.

The emergence of biosimil versions of older biologic drugs also intensifies the competitive pressure. As biosimil penetration grows, it can drive down overall treatment costs and shift market share away from newer, higher-priced innovative therapies.

AbbVie's strategy to secure Rinvoq's market position involves pursuing new indications and leveraging its broad JAK inhibitor portfolio. Expansion into new therapeutic areas, such as atopic dermatitis and atopic dermatitis, has broadened its patient reach and revenue streams.

What are the Projected Market Penetration Rates for Rinvoq?

Rinvoq's market penetration is projected to grow significantly, driven by its expanding indication approvals and the increasing adoption of oral JAK inhibitors across various autoimmune diseases. The drug has demonstrated efficacy in treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis.

For rheumatoid arthritis, a market characterized by substantial unmet need and a shift towards targeted therapies, Rinvoq is expected to capture approximately 15-20% of the biologic-naïve and biologic-experienced patient populations by 2028, reaching an estimated market share of 25-30% by 2032, prior to significant generic entry. This projection is based on its efficacy profile, particularly in moderate to severe disease, and its oral administration advantage over injectables.

In psoriatic arthritis and ankylosing spondylitis, where JAK inhibitors are gaining traction, Rinvoq is anticipated to achieve a market share of 10-15% by 2027, climbing to 18-22% by 2031. These markets are less penetrated by JAK inhibitors compared to rheumatoid arthritis, offering a growth runway.

The atopic dermatitis market presents a substantial opportunity. With approval for moderate-to-severe atopic dermatitis, Rinvoq is projected to secure 12-17% of this market by 2029, potentially reaching 20-25% by 2032 as physician familiarity and patient acceptance increase.

For inflammatory bowel disease, specifically ulcerative colitis, Rinvoq is positioned to capture 8-12% of the market by 2028, with projections reaching 15-18% by 2031. This indication is highly competitive, with multiple biologic and small molecule options available.

The market penetration forecasts are contingent on several factors:

• Continued Clinical Success: Positive real-world evidence and long-term safety data will be crucial.
• Label Expansions: Approvals for additional indications or patient sub-populations will further drive adoption.
• Managed Care Access: Favorable formulary placement and reimbursement policies are essential.
• Generic Competition Timeline: The actual entry of generics, post-patent expiration, will significantly impact market share erosion, particularly after 2031.

By 2030, Rinvoq is projected to achieve a total market share of approximately 20-25% across its approved indications in the United States and major European markets. This trajectory assumes AbbVie successfully navigates patent challenges and maintains a strong marketing presence.

What are the Price Projections for Rinvoq?

Rinvoq's pricing is aligned with other high-cost specialty pharmaceuticals, particularly oral JAK inhibitors and advanced biologics. The average wholesale price (AWP) for Rinvoq is approximately $6,000-$7,000 per month for a standard dosing regimen (e.g., 15 mg or 30 mg daily), translating to an annual cost of $72,000-$84,000 per patient.

The net price, after rebates and discounts negotiated with payers and pharmacy benefit managers (PBMs), is lower, estimated to be in the range of $4,500-$5,500 per month, or $54,000-$66,000 annually per patient. This net pricing is subject to significant fluctuations based on market dynamics and payer negotiations.

Projected Pricing Trends:

• Near-Term (2024-2027): Pricing is expected to remain stable or increase modestly, with annual net price increases of 3-5% due to inflation and continued demand. This period represents peak market exclusivity.
• Mid-Term (2028-2031): As patent expirations approach and generic competition looms, AbbVie may implement more aggressive pricing strategies to maximize revenue before generic entry. However, payer pressure for cost containment will intensify. Net prices are projected to stabilize or see marginal increases of 1-3% annually.
• Post-Patent Expiration (2032 onwards): The introduction of generic upadacitinib will lead to a significant decline in Rinvoq's market price. Generic versions are expected to be priced at 40-60% of the brand name drug's net price within two years of launch. This price erosion will be substantial, impacting Rinvoq's overall revenue.

The pricing strategy will also be influenced by the specific indications. Higher-priced indications with greater unmet needs or more complex treatment pathways may command a slight premium. AbbVie's ability to negotiate favorable market access and formulary placement will be critical in sustaining its pricing power against increasing competition.

The total cost of therapy for Rinvoq, considering its approved indications and patient populations, places it among the most expensive treatment options. This necessitates robust pharmacoeconomic evaluations by payers to justify its use over less expensive alternatives.

How will Generic Entry Impact Rinvoq's Market and Pricing?

The expiration of Rinvoq's foundational U.S. Patent No. 8,703,807 on April 1, 2031, marks the commencement of potential generic competition. However, the actual impact will be nuanced and depend on the expiration of secondary patents and the successful resolution of any ongoing patent litigation.

Impact on Market Share:

• Initial Erosion (2031-2033): Following the expiration of the core API patent, the first generic versions are expected to enter the market. This will lead to an immediate, albeit gradual, erosion of Rinvoq's market share. The pace of this erosion will depend on the number of generic manufacturers entering the market, their manufacturing capacity, and their ability to secure regulatory approval for all relevant indications. Projections suggest a loss of 5-10% of market share within the first year of generic entry.
• Accelerated Decline (2034-2036): As more generics become available and payer formularies begin to favor them, Rinvoq's market share will decline more rapidly. This phase could see a loss of an additional 15-25% of market share.
• Niche Market (Post-2036): Rinvoq may retain a smaller, niche market share driven by physician familiarity, patient preference for the branded product, or specific payer arrangements that favor the original innovator.

Impact on Pricing:

• Price Reduction: Generic entry will trigger a significant price reduction for upadacitinib. The net price is expected to fall by at least 50-60% within two years of the first generic launch. This decline is driven by intense price competition among generic manufacturers and increased pressure from payers to reduce healthcare costs.
• Tiered Pricing: AbbVie may implement a tiered pricing strategy for Rinvoq, offering discounts to maintain market share against generics, particularly in price-sensitive markets or for specific patient segments.
• Impact on New Indications: The threat of generic entry for existing indications will influence the pricing of Rinvoq in any newly approved therapeutic areas. AbbVie may need to justify higher pricing for new indications by demonstrating superior value or addressing significant unmet needs.

The success of AbbVie's patent litigation strategy is a critical variable. Successful defenses against patent challenges or favorable settlement agreements could delay generic entry, extending Rinvoq's exclusivity period and its ability to command premium pricing. Conversely, adverse rulings could accelerate generic competition.

The presence of multiple JAK inhibitors with staggered patent expirations complicates the market dynamics. Generics for Rinvoq will compete not only with the branded Rinvoq but also with other branded JAK inhibitors and their eventual generic counterparts. This will create a highly competitive small molecule landscape, driving down overall prices for JAK inhibitors.

Key Takeaways

• Rinvoq's primary patent protection expires on April 1, 2031, but secondary patents for manufacturing processes and therapeutic uses extend into the late 2030s, potentially delaying comprehensive generic entry.
• The competitive landscape is characterized by other JAK inhibitors (Xeljanz, Olumiant) and established biologics, with increasing intra-company competition from AbbVie's Skyrizi.
• Market penetration is projected to reach 20-25% across approved indications by 2030, driven by expanding indications and oral administration advantages.
• Current net pricing for Rinvoq ranges from $54,000-$66,000 annually per patient, with modest near-term increases expected.
• Generic entry post-2031 is expected to reduce upadacitinib prices by 50-60% within two years and significantly erode Rinvoq's market share.

Frequently Asked Questions

1. What are the chances of Rinvoq receiving an extended exclusivity period beyond its current patent expirations?

Extended exclusivity could arise from new patent filings for novel formulations, manufacturing processes, or combination therapies, or through successful litigation defending existing patents against generic challenges. These events are unpredictable but form a core component of AbbVie's strategy to maximize market longevity.

2. How does Rinvoq's safety profile compare to other JAK inhibitors, and how might this affect its market share?

Rinvoq has a black box warning concerning serious infections, mortality, cardiovascular events, thrombosis, and malignancy, similar to other JAK inhibitors. Clinical trial data and real-world evidence are continuously being evaluated by prescribers and payers, influencing its perceived safety and its place in treatment algorithms. AbbVie's ongoing post-market surveillance and data generation are critical for reinforcing its safety profile.

3. What is the impact of international patent protection on Rinvoq's global market strategy?

Patent protection varies significantly by country. AbbVie's global strategy involves securing broad patent coverage in key markets like the EU, Japan, and China, with corresponding expiration dates and competitive landscapes influencing launch sequencing and pricing. For example, European patent expiries may precede US expiries, leading to earlier generic competition in those regions.

4. How will managed care policies and PBM negotiations influence Rinvoq's access and pricing?

Managed care organizations and PBMs play a crucial role in determining formulary placement and net pricing through rebates and discounts. AbbVie actively negotiates with these entities to ensure favorable access for Rinvoq, balancing market access with revenue generation. Shifting formulary tiers or requiring step-therapy can significantly impact patient uptake and overall market penetration.

5. What are the primary manufacturing challenges for generic upadacitinib that could delay market entry?

Generic manufacturers must replicate not only the upadacitinib molecule but also the precise crystalline forms and manufacturing processes that are often protected by secondary patents. Developing non-infringing processes, ensuring consistent purity and bioavailability, and navigating the complex regulatory approval pathway are significant hurdles that can delay generic market entry even after core patent expiration.

Cited Sources

[1] United States Patent and Trademark Office. (2014). U.S. Patent No. 8,703,807. [2] United States Patent and Trademark Office. (2019). U.S. Patent No. 10,195,334. [3] United States Patent and Trademark Office. (2017). U.S. Patent No. 9,737,571. [4] United States Patent and Trademark Office. (2018). U.S. Patent No. 9,260,414. [5] United States Patent and Trademark Office. (2020). U.S. Patent No. 10,766,908. [6] United States Patent and Trademark Office. (2021). U.S. Patent No. 11,045,777. [7] United States Patent and Trademark Office. (2021). U.S. Patent No. 11,103,668. [8] Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Website] [9] Pfizer Inc. (2012). U.S. Patent No. 8,158,616. [10] Industry market research reports and financial analyst projections (proprietary data).