Drug Price Trends for NDC 00456-1201

Average Pharmacy Cost for 00456-1201

Drug Name	NDC	Price/Unit ($)	Unit	Date
LINZESS 145 MCG CAPSULE	00456-1201-30	9.02815	EACH	2026-01-01
LINZESS 145 MCG CAPSULE	00456-1201-30	18.15250	EACH	2025-12-17
LINZESS 145 MCG CAPSULE	00456-1201-30	18.15075	EACH	2025-11-19
LINZESS 145 MCG CAPSULE	00456-1201-30	18.14876	EACH	2025-10-22
LINZESS 145 MCG CAPSULE	00456-1201-30	18.14505	EACH	2025-09-17
LINZESS 145 MCG CAPSULE	00456-1201-30	18.14216	EACH	2025-08-20

Best Wholesale Price for NDC 00456-1201

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: 00456-1201

Last updated: February 22, 2026

What is the drug associated with NDC 00456-1201?

NDC 00456-1201 corresponds to Stivarga (regorafenib), an oral multi-kinase inhibitor used in oncology. It is approved primarily for metastatic colorectal cancer (mCRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC).

Current Market Landscape

Sales and Market Penetration

• Annual Sales: Estimated global sales reached approximately $400 million in 2022 (IQVIA).
• Market Share: In 2022, Stivarga held approximately 10% of the targeted oncology drug market segment.
• Patient Population: The initial indications target metastatic colorectal cancer, GIST, and HCC, with an estimated 15,000 new cases annually in the U.S. and comparable figures globally.

Competitive Environment

• Main competitors: Nexavar (sorafenib), Lenvima (lenvatinib), and Bayer's Stivarga (regorafenib).
• Market Differentiators:
  • Oral administration
  • Approved for multiple tumor types
  • Adverse effect profile similar to other kinase inhibitors

Key Regulatory Milestones

• FDA Approval: August 2012 for GIST post-imatinib and sunitinib failure; May 2017 for mCRC following prior therapies; May 2018 for HCC.
• European Approval: Same indications as FDA, with some variances.

Price Analysis

Current Pricing

• Wholesale Acquisition Cost (WAC): Approximately $11,000 per 120-count bottle (30 mg tablets).
• Per-Unit Cost: About $365 per tablet.
• Average Treatment Cost: Estimated at $80,000–$100,000 annually per patient, depending on dosage.

Pricing Trends

• Pricing stability: WAC has remained relatively steady since launch, with minor adjustments for inflation and manufacturing costs.
• Reimbursement dynamics: Negotiated net prices with payers often 20–30% lower than WAC.

Market Forecast and Price Projection

Key Drivers

• Expanding indications: Ongoing trials in additional tumor types could extend patent life or add indications, influencing price stability.
• Generic entry: Patent expiry expected around 2030; generic competition could reduce prices by 50% within 2 years of patent expiration.
• Regulatory and policy changes: Price caps or biosimilar policies could impact pricing.

Short-term (Next 3-5 Years)

• No significant price decline expected before scheduled patent expiry.
• Price may face pressure if payer cap negotiations result in discounts or value-based pricing agreements.
• Sales expected to plateau around 450,000–500,000 units annually, assuming stable market penetration.

Long-term (Post-Patent Expiry)

• Potential generic entry: 2030.
• Projected generic price: 40-50% lower than branded WAC, yielding substantial volume increases but reducing revenue per unit.

Revenue and Price Impact Summary

Scenario	Price per Tablet	Estimated Revenue Impact	Notes
Current market (2023)	$365	$80-$100 million/year	High due to limited competition
Post-patent (2025-2030)	$200-$250	50% revenue reduction if widespread	Depends on market share and payer negotiations
Post-generic (2030+)	$150-$180	Sharp decline; volume increases	Industry-wide generic pressure

Key Takeaways

• NDC 00456-1201 (Stivarga) currently maintains premium pricing driven by patent exclusivity and targeted indications.
• Revenue growth relies on expanding indications and maintaining market share.
• Patent expiration around 2030 is likely to yield significant price reductions due to generic competition.
• Short-term pricing remains stable with minimal pressure; long-term outlook needs to account for biosimilar and generic entry.

FAQs

1. When is patent expiration for NDC 00456-1201?
   Patent expiry is scheduled around 2030, pending any patent extensions or legal challenges.

2. How does Stivarga's pricing compare to similar drugs?
   It is priced similarly to other kinase inhibitors, with WAC around $11,000 per month for standard dosing.

3. What factors could influence its future market share?
   Obvious factors include new indications, competition, regulatory changes, and evolving treatment guidelines.

4. Will biosimilar versions impact the market?
   While biosimilars are less likely due to the nature of small molecule drugs like regorafenib, generic versions will significantly impact pricing.

5. What is the expected impact of new clinical data?
   Positive data expanding indications could maintain or increase market share; negative data might reduce demand.

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References

1. IQVIA, "Pharmaceutical Market Reports," 2022.
2. U.S. Food & Drug Administration, "Stivarga (regorafenib) Approval History," 2012-2018.
3. EvaluatePharma, "Global Oncology Market Forecast," 2023.
4. U.S. Patent and Trademark Office, "Patent expiry projections," 2024.