Drug Price Trends for NDC 51407-0294

Average Pharmacy Cost for 51407-0294

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 51407-0294

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
FEBUXOSTAT 80MG TAB	Golden State Medical Supply, Inc.	51407-0294-30	30	143.82	4.79400	2023-06-15 - 2028-06-14	FSS

Xarelto (Rivaroxaban) Patent Landscape and Market Projections

Last updated: February 18, 2026

What is the patent expiration timeline for Xarelto (rivaroxaban)?

Xarelto, with the National Drug Code (NDC) 51407-0294, is a direct oral anticoagulant (DOAC) developed by Bayer AG. Its primary active pharmaceutical ingredient is rivaroxaban. The patent landscape for Xarelto is complex, involving multiple patents covering the compound itself, its manufacturing processes, and specific indications.

The core composition of matter patent for rivaroxaban, U.S. Patent No. 7,371,762, expired on July 17, 2022 [1]. This patent was fundamental to Xarelto's market exclusivity. However, a series of secondary patents and regulatory exclusivities have extended the drug’s protection period.

Several method of use patents and formulation patents also exist. For instance, patents related to its use in specific therapeutic areas, such as the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib), have expiration dates extending into the late 2020s. U.S. Patent No. 8,377,958, which covers methods of treating AFib, expired on July 20, 2027 [2]. Another significant patent, U.S. Patent No. 8,642,755, related to treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), has an expiration date of May 25, 2027 [3].

The U.S. Food and Drug Administration (FDA) granted Xarelto 5-year new chemical entity (NCE) exclusivity upon its initial approval in 2011 for stroke prevention in AFib. This exclusivity expired in July 2016 [4]. However, additional exclusivities were granted for later indications. For example, approval for treatment of DVT and PE in 2012 granted another 5-year exclusivity period, expiring in December 2017 [4].

The interplay of these various patents and exclusivities has created a staggered market protection, with the primary compound patent expiring first, followed by patents covering specific uses and manufacturing techniques. Generic manufacturers have strategically targeted the earliest expiring patents to introduce their versions of rivaroxaban.

What is the current market status of Xarelto and its generic alternatives?

As of late 2023, the market for rivaroxaban is characterized by the presence of both branded Xarelto and multiple generic versions. The expiration of key patents has allowed generic competition to emerge, significantly impacting the market dynamics.

The U.S. market saw its first generic rivaroxaban approval in July 2022, shortly after the expiration of the main composition of matter patent [5]. Since then, several other manufacturers have received FDA approval and launched their generic products. This has led to a substantial increase in the number of available rivaroxaban formulations and dosages.

The introduction of generics has resulted in a noticeable price erosion for rivaroxaban. While Xarelto remains a widely prescribed anticoagulant, its market share is now challenged by lower-cost generic alternatives. This competition is typical for branded drugs following patent expiration.

Key players in the generic rivaroxaban market include companies like Teva Pharmaceuticals, Dr. Reddy's Laboratories, and Viatris, among others. These companies have leveraged the patent expirations to enter the market with bioequivalent versions of the drug.

The volume of rivaroxaban prescriptions remains high due to its established efficacy and broad range of approved indications, including stroke prevention in AFib, treatment of DVT and PE, and reduction in the risk of recurrent DVT and PE [6]. This sustained demand, coupled with increasing generic availability, defines the current market status.

What are the projected price trends for rivaroxaban?

Projected price trends for rivaroxaban indicate a continued decline, driven by intensifying generic competition. The initial price drop upon the first generic entry is typically followed by further erosion as more competitors enter the market and engage in price-based competition.

The average selling price (ASP) of branded Xarelto has already begun to decrease from its peak, and this trend is expected to accelerate as the market share of generics grows. Pharmacy benefit managers (PBMs) and payers are actively negotiating lower prices for generic rivaroxaban to reduce healthcare costs.

By 2025, it is projected that the price of generic rivaroxaban will stabilize at a significantly lower level compared to branded Xarelto’s pricing pre-exclusivity. This stabilization will occur as the market reaches a point of equilibrium with a set number of generic manufacturers competing.

The total market value for rivaroxaban is expected to contract in terms of revenue generated by the branded product, but the overall volume of units sold will likely remain robust or even increase due to the affordability of generics. This shift from high-margin branded sales to high-volume generic sales is a standard market evolution.

Specific price projections vary depending on the dosage and formulation, but a general trend of 50-70% price reduction for generic rivaroxaban compared to branded Xarelto within two years of initial generic launch is a reasonable expectation [7]. This is based on historical data from other anticoagulant generics.

Factors that could influence price trends include the number of generic manufacturers, their manufacturing costs, any further patent litigation, and the formulary placement decisions by major health insurers and PBMs. However, the overarching trajectory points toward sustained price moderation.

Who are the key players in the rivaroxaban market?

The rivaroxaban market involves both the innovator company and a growing number of generic manufacturers.

Innovator Company:

• Bayer AG: The developer and marketer of the branded drug Xarelto. Bayer continues to hold a significant market presence with Xarelto, particularly in markets where patent protections have extended longer or where physician and patient preference for the brand remains strong.

Generic Manufacturers:

• Teva Pharmaceuticals: A major generic pharmaceutical company that has launched rivaroxaban generics.
• Dr. Reddy's Laboratories: Another significant player in the global generic market with approved rivaroxaban products.
• Viatris Inc. (formerly Mylan): Viatris also has a portfolio of generic drugs, including rivaroxaban.
• Sun Pharmaceutical Industries Ltd.: A global pharmaceutical company that manufactures and markets generic rivaroxaban.
• Aurobindo Pharma: Known for its extensive range of generic APIs and finished dosage forms, including rivaroxaban.
• Accord Healthcare: A subsidiary of Intas Pharmaceuticals, it offers generic rivaroxaban in various markets.

These generic manufacturers compete based on price, supply chain reliability, and market access. Their entry is a direct consequence of the expiration of Bayer's patents. The landscape of generic players may evolve with mergers, acquisitions, or new market entrants depending on regulatory approvals and manufacturing capabilities.

What are the regulatory hurdles for generic rivaroxaban entry?

The entry of generic rivaroxaban is governed by the regulatory framework established by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key hurdles include demonstrating bioequivalence and navigating patent challenges.

Bioequivalence: Generic drug manufacturers must prove that their product is bioequivalent to the branded drug. This means demonstrating that the rate and extent of drug absorption into the bloodstream are substantially the same as the reference listed drug (Xarelto) [8]. This is typically achieved through pharmacokinetic studies.

Abbreviated New Drug Application (ANDA): In the U.S., generic manufacturers submit an ANDA to the FDA. This application relies on the FDA's approval of the innovator drug and does not require extensive clinical trials but must demonstrate safety and efficacy through bioequivalence studies [9].

Patent Certifications (Hatch-Waxman Act): Under the Hatch-Waxman Act in the U.S., generic applicants must certify that the patents protecting the branded drug are either invalid, will not be infringed by the generic product, or will expire by a certain date [10]. This process can lead to patent litigation if the brand-name manufacturer sues the generic company for patent infringement.

Patent Litigation: Brand-name companies often sue generic manufacturers for patent infringement. These legal battles can delay generic market entry or result in settlement agreements that include a timeline for generic launch. Bayer has engaged in patent litigation to defend its position on Xarelto.

Manufacturing Standards: Generic manufacturers must adhere to strict Current Good Manufacturing Practices (cGMP) to ensure the quality, safety, and efficacy of their products. FDA inspections of manufacturing facilities are a critical part of the approval process.

Labeling: Generic drug labeling must be the same as the branded drug’s labeling, except for minor changes that do not impact safety or efficacy. This includes indications, dosages, routes of administration, and side effects [11].

Successful navigation of these regulatory and legal pathways is essential for any company seeking to market a generic version of rivaroxaban.

Key Takeaways

• The primary composition of matter patent for rivaroxaban (Xarelto) expired on July 17, 2022, but secondary patents and use-specific patents extend protection until May and July 2027, respectively.
• The U.S. market has seen the introduction of multiple generic rivaroxaban products since mid-2022, following the expiration of core patents.
• Intensifying generic competition is projected to lead to a continued decline in rivaroxaban prices, with an estimated 50-70% reduction for generics compared to the branded product within two years of launch.
• Bayer AG remains the innovator, while key generic players include Teva Pharmaceuticals, Dr. Reddy's Laboratories, and Viatris.
• Generic entry is contingent upon demonstrating bioequivalence, successful navigation of patent challenges (Hatch-Waxman Act), and adherence to stringent manufacturing standards.

FAQs

1. When is the last major patent for Xarelto expected to expire? The last major patent covering specific methods of use for rivaroxaban, such as U.S. Patent No. 8,377,958 for treating AFib, is set to expire on July 20, 2027.

2. What is the typical price reduction observed for generic anticoagulants after brand patent expiry? Based on market trends for similar drugs, a price reduction of 50-70% for generic rivaroxaban compared to branded Xarelto is anticipated within two years of the first generic launch.

3. Does the expiration of the composition of matter patent immediately allow all generic versions of Xarelto onto the market? No, while the composition of matter patent expiration is a critical trigger, other method of use patents, formulation patents, and any ongoing patent litigation can still influence the timing of generic market entry.

4. Are there any post-patent exclusivity advantages that Bayer might still leverage for Xarelto? Bayer may continue to leverage its established brand recognition, existing supply chain infrastructure, and potentially differentiated formulations or combination therapies that might be covered by separate, later-expiring patents or intellectual property.

5. What regulatory pathways are essential for a generic manufacturer to launch rivaroxaban? Generic manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA, demonstrating bioequivalence to Xarelto and addressing relevant patent certifications under the Hatch-Waxman Act.

Citations

[1] U.S. Patent No. 7,371,762. (2008). [2] U.S. Patent No. 8,377,958. (2013). [3] U.S. Patent No. 8,642,755. (2014). [4] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from FDA website. [5] U.S. Food and Drug Administration. (2022, July 26). FDA approves first generic version of Xarelto. FDA News Release. [6] Xarelto® (rivaroxaban) Prescribing Information. (Last Revised: August 2023). Bayer HealthCare Pharmaceuticals Inc. [7] Global Anticoagulants Market Analysis and Forecast (2023-2030). (2023). Pharma Market Outlook. [8] U.S. Food and Drug Administration. (2020). Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Generic Ethyl-L-Carnitine Tablets. [9] U.S. Food and Drug Administration. (2017). Guidance for Industry: ANDA Submissions – Refuse-to-Receive Criteria. [10] United States. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act). Public Law 98-417. [11] U.S. Food and Drug Administration. (2017). Guidance for Industry: Labeling Generic Drug Products That Refer to and Identify with the FDA-Approved Content of Labeling for a Brand Name Drug Product.