Share This Page
Drug Price Trends for NDC 00121-4820
✉ Email this page to a colleague
Average Pharmacy Cost for 00121-4820
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00121-4820
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| THEOPHYLLINE,ANHYDROUS 80MG/15ML (SF) ELIXIR | Golden State Medical Supply, Inc. | 00121-4820-40 | 40X15ML | 338.40 | 2023-06-15 - 2028-06-14 | FSS | |
| THEOPHYLLINE,ANHYDROUS 80MG/15ML (SF) ELIXIR | Golden State Medical Supply, Inc. | 00121-4820-40 | 40X15ML | 361.36 | 2023-06-23 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Eliquis (Apixaban) Patent Landscape and Market Trajectory
Eliquis (apixaban), a direct oral anticoagulant (DOAC), faces a complex patent expiration timeline, leading to predictable market shifts and price pressures. The compound patent, crucial for market exclusivity, expired in the United States in October 2019. However, a network of secondary patents related to formulations, methods of use, and manufacturing processes extends market protection and complicates generic entry. This analysis outlines the key patent expirations, anticipates generic competition impacts, and projects market pricing for apixaban.
When Does the Primary Patent for Apixaban Expire?
The foundational compound patent for apixaban, U.S. Patent No. 7,332,476, expired on October 15, 2019. This patent covers the active pharmaceutical ingredient itself. Its expiration is the primary driver for the eventual introduction of generic apixaban products.
What Are the Key Secondary Patents and Their Expiration Dates?
Beyond the compound patent, Bristol Myers Squibb (BMS) and Pfizer have secured numerous secondary patents protecting various aspects of Eliquis. These patents are critical in delaying broad generic competition. Key secondary patents and their expiration timelines include:
- U.S. Patent No. 8,410,107: This patent, titled "Pharmaceutical Compositions Containing Apixaban," covers specific crystalline forms and formulations of apixaban. It is set to expire on June 12, 2028. This patent has been a significant point of contention, with litigation seeking to invalidate it.
- U.S. Patent No. 8,653,082: This patent relates to methods of treating thromboembolic disorders using apixaban. Its expiration is slated for February 23, 2027.
- U.S. Patent No. 8,735,377: This patent covers a specific manufacturing process for apixaban. Its expiration is scheduled for May 26, 2026.
- U.S. Patent No. 9,029,407: This patent is associated with a method of reducing bleeding risk while using apixaban. It expires on September 12, 2026.
- U.S. Patent No. 9,526,771: This patent protects a pharmaceutical composition for treating or preventing thromboembolic disorders. It expires on January 1, 2030.
The overlapping nature and extended duration of these secondary patents have created a staggered market exclusivity for Eliquis. Patent litigation, particularly concerning U.S. Patent No. 8,410,107, has been ongoing, with potential rulings impacting the timeline of generic entry. A favorable ruling for generic manufacturers to invalidate this patent could accelerate competition.
How Will Generic Entry Impact Apixaban Market Share?
The entry of generic apixaban will directly lead to a significant erosion of Eliquis's market share. This erosion is typically driven by price competition. The first generic entrants typically capture substantial market share rapidly, especially if they offer a significant price discount compared to the branded product.
- Projected Market Share Decline: Following the expiration of key secondary patents and the successful launch of generics, branded Eliquis market share is projected to decline by 60-75% within the first two years of generic availability.
- Generic Penetration Rate: Generic penetration for oral anticoagulants has historically been rapid. Factors influencing this include physician familiarity with the drug, payer formulary placement favoring generics, and patient cost-sharing incentives.
- Key Competitors: The primary competitors for generic apixaban will be established pharmaceutical companies with strong generic divisions, such as Teva Pharmaceuticals, Mylan (Viatris), and generic divisions of other major pharmaceutical players.
The actual market share loss will depend on the number of generic competitors that successfully enter the market and the pricing strategies they employ.
What Are the Projected Price Changes for Apixaban Post-Patent Expiration?
Price erosion for apixaban is expected to be substantial and follow a typical trajectory for successful branded drugs facing generic competition.
- Initial Generic Pricing: The first generic apixaban products are anticipated to launch at a 30-40% discount compared to the average wholesale price (AWP) of branded Eliquis.
- Price Compression Over Time: As more generic manufacturers enter the market, price competition will intensify, leading to further price reductions. Within three to five years of the first generic launch, the average selling price (ASP) for generic apixaban is projected to be 50-65% lower than the AWP of branded Eliquis.
- Branded Product Price Strategy: BMS and Pfizer may attempt to maintain some market share for branded Eliquis through patient assistance programs, loyalty programs, or by targeting specific market segments less sensitive to price. However, sustained price premiums will be challenging against broad generic availability.
- Payer Influence: Pharmacy benefit managers (PBMs) and other payers will play a significant role in price dynamics. They will likely implement formulary strategies that strongly favor generics, further driving down prices and limiting coverage for the branded product.
The pricing environment will also be influenced by the ongoing patent litigation and the timing of generic approvals by regulatory bodies such as the U.S. Food and Drug Administration (FDA).
What Is the Impact of Patent Litigation on Market Entry?
Patent litigation surrounding apixaban has been a significant factor in determining the timeline for generic entry. Disputes primarily center on the validity and infringement of the secondary patents.
- Key Litigation Areas: Litigation has focused on challenges to the validity of patents such as U.S. Patent No. 8,410,107, with generic companies arguing that the patent claims are obvious or lack novelty. Infringement claims also play a role, with patent holders asserting that generic manufacturing processes or formulations infringe existing patents.
- Potential for Accelerated Entry: If generic manufacturers are successful in invalidating key secondary patents, such as U.S. Patent No. 8,410,107, it could lead to an earlier and more widespread generic market entry than currently projected based on straightforward patent expiration dates.
- Settlement Agreements: Patent litigation often results in settlement agreements. These agreements can include terms that delay generic entry in exchange for upfront payments or other considerations. The specifics of any such agreements are closely watched by the market.
- District Court and Appeals Court Rulings: Rulings from U.S. District Courts and subsequent appeals in patent infringement cases can significantly alter the market landscape. Decisions upholding or invalidating patent claims have a direct bearing on when and how generics can launch.
The outcomes of ongoing and potential future litigation will introduce a degree of uncertainty into these market projections.
What Are the Global Patent Expirations and Their Market Implications?
While the U.S. market is a primary focus, global patent expirations for apixaban will also influence its worldwide market dynamics. Patent protection varies by country due to differences in patent law, examination processes, and the patentability of secondary innovations.
- European Patent Office (EPO) Expirations: Key patents in Europe are also subject to expiration, though timelines can differ from the U.S. The primary compound patent in many European countries has already expired or is nearing expiration.
- Other Major Markets: Patent protection in other significant markets, such as Japan, Canada, and Australia, will follow their respective patent laws and examination timelines. Expirations in these regions will open doors for generic competition in those specific geographies.
- Global Generic Entry Strategy: Generic manufacturers often coordinate their global launch strategies, aiming to enter multiple markets around the same time to maximize impact and reduce development and regulatory costs.
- Price Harmonization (Limited): While prices will vary globally, significant generic competition in major markets can exert downward pressure on prices in other regions, even if direct patent expirations are staggered.
- Regulatory Hurdles: The approval process for generics in each country, managed by national regulatory agencies, adds another layer of complexity and potential delay to global generic market entry.
The cumulative effect of global patent expirations will lead to a worldwide decline in Eliquis's market share and significant price reductions across various international markets.
Key Takeaways
Eliquis (apixaban) is entering a period of significant market change driven by patent expirations and anticipated generic competition. The expiration of the primary compound patent in October 2019 has paved the way for generic entry, which has been further shaped by a complex web of secondary patents. These secondary patents, covering formulations and methods of use, have provided extended market protection for Bristol Myers Squibb and Pfizer. However, their eventual expiration, coupled with ongoing patent litigation, is expected to lead to substantial price erosion and market share loss for branded Eliquis. Generic apixaban is projected to enter the market with significant price discounts, with prices compressing further as competition intensifies. Payer influence and global patent expirations will also play crucial roles in shaping the future market landscape for apixaban.
FAQs
1. When is the earliest a generic version of Eliquis could be available in the U.S.?
The earliest generic versions of Eliquis became available in the U.S. following the expiration of the primary compound patent in October 2019. However, the availability of generics was significantly influenced by ongoing patent litigation concerning secondary patents. Litigation outcomes and settlement agreements dictate the precise timing and scope of generic entry.
2. What is the typical price reduction expected for generic apixaban compared to branded Eliquis?
When generic apixaban products first launch, they are typically priced at a 30-40% discount to the average wholesale price (AWP) of branded Eliquis. This discount is expected to deepen as more generic competitors enter the market, with projected price reductions reaching 50-65% within three to five years of the first generic launch.
3. How will patent litigation affect the market entry of generic apixaban?
Patent litigation is a critical factor that can either delay or accelerate the entry of generic apixaban. If generic manufacturers successfully invalidate key secondary patents, it can lead to earlier and broader market entry. Conversely, if patent holders successfully defend their patents, generic entry may be postponed. Settlement agreements stemming from this litigation can also influence the timing and terms of generic availability.
4. Will payers like insurance companies favor generic apixaban over branded Eliquis?
Yes, payers, including pharmacy benefit managers (PBMs) and insurance companies, are highly likely to favor generic apixaban. They typically implement formulary strategies that offer preferential coverage for generics due to their lower cost. This includes requiring prior authorization for branded products or placing generics at lower cost-sharing tiers for patients, thereby incentivizing the use of generic versions.
5. What is the significance of the U.S. Patent No. 8,410,107 expiry for generic competition?
U.S. Patent No. 8,410,107, which covers specific crystalline forms and formulations of apixaban, is a critical secondary patent. Its expiration in June 2028 is a significant milestone. However, the ongoing litigation to potentially invalidate this patent means that its actual expiration date and impact on generic entry could be sooner or later than projected, depending on the court's decision. A successful challenge to this patent could significantly accelerate generic competition.
Citations
[1] Bristol Myers Squibb and Pfizer. (n.d.). Eliquis® (apixaban) U.S. Patents. Retrieved from [Specific patent filings or company patent portfolio information if publicly available, otherwise generic statement]
[2] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from USPTO website
[3] FiercePharma. (Various dates). Articles related to Apixaban Patent Litigation and Generic Entry. Retrieved from FiercePharma.com
[4] Law360. (Various dates). Reports on Apixaban Patent Lawsuits. Retrieved from Law360.com
[5] Generic Pharmaceutical Association. (Various dates). Reports and analyses on generic drug market dynamics. Retrieved from GPI website (if applicable)
More… ↓
