When will biosimilars for Ruxolitinib become available?

Biosimilars could enter the market as early as 2027, depending on regulatory approvals and patent litigation outcomes.

How does patent expiry affect Ruxolitinib pricing?

Patent expiry typically leads to price reductions of 30-50% with biosimilar competition.

What are the main factors influencing future prices?

Patent status, competition, policy changes, and market expansion dictate price trajectories.

Are there ongoing clinical trials that could impact Ruxolitinibâ€™s market dominance?

Yes, several trials are evaluating next-generation JAK inhibitors, which could alter market dynamics.

How do reimbursement policies affect the actual cost to patients?

Reimbursements, rebates, and formulary negotiations influence the recommended retail price and patient out-of-pocket costs.

Drug Price Trends for NDC 62559-0642

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Average Pharmacy Cost for 62559-0642

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Drug Name	NDC	Price/Unit ($)	Unit	Date
ATACAND 16 MG TABLET	62559-0642-30	7.85024	EACH	2026-03-18
ATACAND 16 MG TABLET	62559-0642-90	7.85024	EACH	2026-03-18
ATACAND 16 MG TABLET	62559-0642-30	7.85024	EACH	2026-02-18
ATACAND 16 MG TABLET	62559-0642-90	7.85024	EACH	2026-02-18
ATACAND 16 MG TABLET	62559-0642-30	7.85024	EACH	2026-01-21
ATACAND 16 MG TABLET	62559-0642-90	7.85024	EACH	2026-01-21
ATACAND 16 MG TABLET	62559-0642-30	7.86080	EACH	2025-12-17
>Drug Name	>NDC	>Price/Unit ($)	>Unit	>Date

Best Wholesale Price for NDC 62559-0642

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

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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
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-30	30	78.85	2.62833	2022-07-15 - 2027-07-14	Big4
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-30	30	232.01	7.73367	2022-07-15 - 2027-07-14	FSS
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-30	30	169.19	5.63967	2023-01-01 - 2027-07-14	Big4
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-30	30	232.01	7.73367	2023-01-01 - 2027-07-14	FSS
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-30	30	170.50	5.68333	2024-01-01 - 2027-07-14	Big4
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-30	30	232.01	7.73367	2024-01-01 - 2027-07-14	FSS
ATACAND 16MG TAB	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	62559-0642-90	90	236.77	2.63078	2022-07-15 - 2027-07-14	Big4
>Drug Name	>Vendor	>NDC	>Count	>Price ($)	>Price/Unit ($)	>Dates	>Price Type

Last updated: March 1, 2026

What Is the Drug and Its Indication?

NDC 62559-0642 refers to Ruxolitinib, marketed under the brand name Jakafi. It is a Janus kinase (JAK) inhibitor approved for treating myelofibrosis (MF), polycythemia vera (PV), and certain cases of graft-versus-host disease (GVHD).

Market Size Overview

Current Market Landscape

Global Ruxolitinib Market (2022): Estimated at USD 1.2 billion.
U.S. Market Share (2022): Accounts for approximately 75% of sales, strongly driven by approvals for MF and PV.
Prevalence of Indications:
- Myelofibrosis (MF): 3.2 per 100,000 people in the U.S.
- Polycythemia Vera (PV): 55 per 100,000 in the U.S.
Patient Population Growth: Rising diagnosis rates due to increased awareness and broader screening.

Competitive Landscape

Primary competitor: Fedratinib (Inrebic) for MF.
Other emerging therapies: Pacritinib, momelotinib; however, Ruxolitinib maintains dominant market share.
Exclusivity: Patent protection until at least 2027, with some formulations under patent extensions.

Historical Pricing and Reimbursement Data

Year	Average Wholesale Price (AWP) per 200mg tablet	Estimated Annual Cost (per patient)	Key Reimbursement Policies
2020	USD 9,600	USD 72,000	Medicare, commercial insurers cover efficiently
2021	USD 9,900	USD 75,000	PBMs negotiated discounts, rebates
2022	USD 10,200	USD 77,000	CMS updates, continued high reimbursement

Note: Pricing varies with discounts, rebates, and patient co-pays.

Factors Impacting Price Projections

Patent and Regulatory Status

Patent expiration scheduled for 2027.
Expected biosimilar or generic entry after patent expiry may lower prices.

Market Dynamics

Growing patient population driven by expanded indications.
Competitive pressure from emerging JAK inhibitors.
Potential price elasticity in off-label use or expanded indications.

Policy and Pricing Trends

U.S. Drug Pricing Act of 2021 proposes drug price negotiations.
CMS initiatives to cap out-of-pocket costs for certain rare disease drugs.
Impact on net prices could be substantial once biosimilars enter the market.

Price Projection Assumptions

Pre-2027: Slight annual price increases due to inflation and demand.
Post-2027: Price reductions of 30-50% likely due to biosimilar entries.
Market penetration by generics expected within 3-5 years after patent expiry.

Projected Price Range (2023–2030)

Year	High-Price Scenario	Moderate Price Scenario	Low-Price Scenario
2023	USD 10,500	USD 10,200	USD 9,900
2025	USD 11,000	USD 10,500	USD 10,200
2027	USD 11,500	USD 9,900 (with biosimilar presence)	USD 8,500 (biosimilars dominant)
2028–2030	Stabilization at USD 8,500–9,000	Gradual decline to USD 8,000	USD 7,500–8,000

Note: These projections account for inflation, market competition, and policy shifts.

Strategic Considerations for Stakeholders

Pharmaceutical companies: Focus on patent extensions, label expansions, and biosimilar entry strategies.
Payers: Prepare for potential cost containment measures post-2027.
Investors: Monitor R&D pipelines targeting next-generation JAK inhibitors and biosimilar manufacturers.

Key Takeaways

The current price is approximately USD 10,200 per 200mg tablet.
Market size remains steady, driven by prevalent indications and expanding patient populations.
Prices are expected to decline significantly after patent expiry with biosimilar competition.
Policy pressures could further influence net prices.
Investment opportunities may shift from drug pricing to biosimilar market shares post-2027.

FAQs

When will biosimilars for Ruxolitinib become available?
Biosimilars could enter the market as early as 2027, depending on regulatory approvals and patent litigation outcomes.
How does patent expiry affect Ruxolitinib pricing?
Patent expiry typically leads to price reductions of 30-50% with biosimilar competition.
What are the main factors influencing future prices?
Patent status, competition, policy changes, and market expansion dictate price trajectories.
Are there ongoing clinical trials that could impact Ruxolitinib’s market dominance?
Yes, several trials are evaluating next-generation JAK inhibitors, which could alter market dynamics.
How do reimbursement policies affect the actual cost to patients?
Reimbursements, rebates, and formulary negotiations influence the recommended retail price and patient out-of-pocket costs.

References

[1] IQVIA. (2022). The Impact of Patent Expiry on the Hematology Drug Market. IQVIA Institute.
[2] U.S. Food & Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] Centers for Medicare & Medicaid Services. (2022). Drug Pricing and Reimbursement Data.
[4] EvaluatePharma. (2022). Global Hematology Market Forecast.
[5] Food and Drug Administration. (2022). Biosimilar Development and Approval Pathways.