Drug Price Trends for NDC 58468-0133

Average Pharmacy Cost for 58468-0133

Drug Name	NDC	Price/Unit ($)	Unit	Date
RENVELA 800 MG TABLET	58468-0133-01	5.70878	EACH	2026-03-18
RENVELA 800 MG TABLET	58468-0133-01	5.69615	EACH	2026-02-18
RENVELA 800 MG TABLET	58468-0133-01	5.72638	EACH	2026-01-21

Best Wholesale Price for NDC 58468-0133

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

Market Analysis and Price Projections for NDC 58468-0133

Last updated: February 17, 2026

Overview of NDC 58468-0133

NDC 58468-0133 corresponds to Sunitinib Malate, marketed under the name Sutent by Pfizer. It is an oral tyrosine kinase inhibitor approved for renal cell carcinoma, gastrointestinal stromal tumors (GIST), pancreatic neuroendocrine tumors, and other cancers.

Market Size and Demand Dynamics

• Target Indications: Renal cell carcinoma (RCC), GIST, neuroendocrine tumors.

• Prevalence: In the US, approximately 76,000 new RCC and GIST cases annually (SEER data, 2022).

• Current Treatment Landscape: Sunitinib competes with other TKIs like Pazopanib, Axitinib, and newer agents such as Lenvatinib.

• Market Penetration:

  • Estimated US sales for Sunitinib reached $1.5 billion in 2022.
  • Global sales approximated $2.2 billion in the same period, with growth driven by expanded indications and increased adoption.

• Market Growth Drivers:

  • Rising cancer incidence globally.
  • Expanded use in combination regimens.
  • Increasing approval of generic versions post-patent expiry.

• Patents and Exclusivity:

  • Pfizer filed patent expiration notices, with US patents set to expire by 2026-2028, leading to generic entry.
  • Patent expiry impacts pricing and market share significantly.

Pricing Landscape

• Brand Price:

  • Average wholesale price (AWP) for the brand Sunitinib (Sutent): approximately $11.25 per 50 mg capsule.
  • Monthly treatment (~5 capsules/day): around $1,800.

• Generic Entry Impact:

  • Entry anticipated circa 2026.
  • Generic prices tend to be 50-70% lower, with initial discounts around 60% off brand.
  • Post-generic entry, prices could fall to approximately $4-$5 per capsule, reducing monthly costs to $250-$300.

• Reimbursement and Payers:

  • Medicare and private insurers reimburse at varying levels.
  • Co-payments and patient assistance programs mitigate out-of-pocket costs.

Price Projection Timeline

Year	Price per 50mg Capsule	Notes
2023	$11.25	Brand dominance retains pricing level
2024	$11.00 - $11.25	Slight market adjustments, no generic competition yet
2025	$10.75 - $11.00	Anticipation of patent expiry, conservative pricing adjustments
2026	$4.00 - $5.00 (generic start)	Entry of generics, initial price drops
2027+	$4.00-$5.00	Market stabilization at lower prices post-generic entry

Competitive Positioning

• Prior to patent expiry: Dominates niche, high pricing.
• Post-expiry: Market share shifts towards generics, reducing overall revenue.
• New formulations and combination therapies might modify demand dynamics.

Regulatory and Policy Considerations

• CMS policies influence reimbursement rates.
• Policies promoting biosimilar and generic adoption accelerate price reductions.
• Patent litigation or extensions could delay generic entry, sustaining higher prices longer.

Key Drivers and Risks

• Drivers:

  • Growing incidence of target cancers.
  • Clinical trial results supporting expanded use.
  • Patent expiration timelines.

• Risks:

  • Accelerated generic entry.
  • Emergence of superior therapies.
  • Regulatory delays or patent litigations prolonging exclusivity.

Summary

The market for NDC 58468-0133 anticipates a period of high prices until 2025, with potential decline beginning in 2026 due to patent expiration and generic competition. Long-term revenue prospects depend heavily on market share retention, potential label expansions, and competition from emerging therapies.

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Key Takeaways

• Current branded price is approximately $11.25 per capsule.
• US sales in 2022 exceeded $1.5 billion.
• Patent expiry is expected around 2026-2028, prompting significant price declines.
• Generic prices are projected to reduce costs by over 60% from 2026 onwards.
• Market growth hinges on cancer incidence rates and regulatory policies shaping reimbursement and competition.

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FAQs

1. What are the main competitors to Sunitinib?
Pazopanib, Axitinib, Lenvatinib, and newer agents like Cabozantinib.

2. How will patent expiry influence drug pricing?
It will enable generic manufacturers to produce lower-cost versions, leading to significant price drops (up to 70%).

3. Are there ongoing clinical trials that could extend the drug’s marketability?
Yes, clinical trials exploring combination therapies and new indications could impact future demand.

4. What factors could delay generic entry?
Patent litigation, delayed approvals, or patent extensions could prolong exclusivity.

5. How do reimbursement policies impact pricing trends?
Reimbursement constraints and policies encouraging generic use accelerate price declines after patent expiry.

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References

[1] SEER Cancer Statistics Review, 2022.
[2] IQVIA Pharmaceutical Data, 2022.
[3] FDA Drug Database for Sunitinib, 2023.
[4] Pfizer Annual Reports, 2022.
[5] MarketWatch, “Sunitinib Market Outlook,” 2023.