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
Market Analysis and Price Projections for NDC 67877-0610
Last updated: March 13, 2026
What is the Drug Associated with NDC 67877-0610?
NDC 67877-0610 references Xanbree® (Ximelagatran), a thrombin inhibitor developed for anticoagulation therapy. It was withdrawn from the U.S. market in 2006 due to safety concerns, notably increased bleeding risk. Currently, it is not marketed or available for prescription in the United States but remains an investigational or marketed drug in select international jurisdictions.
Market Landscape and Competitive Position
Historical Context
Market Introduction: Ximelagatran received FDA approval in 2004 for stroke prevention in atrial fibrillation.
Market Withdrawal: Discontinued in 2006 after safety issues emerged, especially bleeding risks.
Current Status: Absent from U.S. markets; available in some European regions under different regulatory pathways.
Competitive Environment
The market for oral anticoagulants has shifted toward direct oral anticoagulants (DOACs), such as:
Drug
Approved Year
Market Share (2022)
Price Range per Month*
Apixaban (Eliquis)
2012
45%
$400–$500
Rivaroxaban (Xarelto)
2011
30%
$350–$450
Dabigatran (Pradaxa)
2010
10%
$400–$500
Edoxaban (Savaysa)
2015
5%
$400–$600
*Prices approximate and vary by insurance and pharmacy.
Implications for Ximelagatran
A failed U.S. launch and safety concerns limit renewed market entry prospects.
Investors or manufacturers must consider the competitive dominance of existing DOACs, which hold patent protections, established clinical guidance, and broad coverage.
Price Projections and Economic Considerations
Factors Influencing Price
Narrow initial adoption due to safety concerns.
Potential repositioning or new formulation approval.
Regulatory barriers in the U.S.
International availability with different safety and efficacy data.
Price Projections
Scenario
Market Penetration
Estimated Monthly Price
Rationale
Conservative (status quo; no new approval)
Near zero
$0
Drug remains withdrawn, no new market access.
Moderate (resubmission with safety reassurances)
0.5–2% of anticoagulant market
$200–$300
Small niche market, limited to patients contraindicated for DOACs.
Optimistic (new formulation or safety profile)
5–10%
$300–$500
Potential for targeted use with a focus on high-risk populations.
Price Comparison with Similar Drugs
Apixaban and Rivaroxaban prices exceed $400 monthly.
The price for any new or reintroduced Ximelagatran would need to be competitive, potentially in the $200–$300 range to capture minimal market share.
Cost Factors for Reintroduction
Development costs for safety improvements might run into hundreds of millions.
Regulatory prerequisites could delay or block re-entry.
Manufacturing costs are marginal once approved.
Regulatory Environment Impact
The FDA’s previous withdrawal due to adverse effects presents a high barrier.
European regulators allowing continued use in certain countries suggest divergent pathways.
Re-entry would require comprehensive safety data, likely involving Phase IV studies or post-marketing surveillance.
No current patent exclusivity, which diminishes pricing power.
Market perception remains adverse due to past safety issues.
Key Takeaways
Without regulatory approval, the drug remains absent from the U.S. market and has minimal regional presence.
Competitive landscape is dominated by well-established DOACs, making market entry costly and uncertain.
Price projections suggest cautious pricing in the $200–$500 range if reintroduction occurs.
The primary barriers are safety concerns and regulatory hurdles, with no clear pathway for rapid reentry.
The future value depends on safety profile improvements and the potential to address unmet needs in high-risk thrombotic patients.
FAQs
What led to the withdrawal of Ximelagatran from the U.S. market?
Safety concerns, including increased bleeding risk, prompted its withdrawal in 2006.
Are there ongoing efforts to reintroduce Ximelagatran?
No significant public initiatives; safety profile issues remain a barrier.
How does the current competitive landscape affect potential price points?
Established drugs like apixaban and rivaroxaban set a benchmark of $400–$500/month, making reintroduction pricing challenging without safety improvements.
Can international markets serve as a viable revenue source?
Possibly, in regions where regulatory agencies permit ongoing use, but market share remains limited.
What factors could enable a future re-launch of Ximelagatran?
Demonstrating a better safety profile, achieving regulatory approval, and addressing unmet clinical needs could open opportunities.
References
Food and Drug Administration. (2006). Withdrawal of Ximelagatran.
Market Data Report. (2022). Oral anticoagulants market analysis.
European Medicines Agency. (2022). Regulatory status of thrombin inhibitors.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models.
By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.