Drug Markets/Hydroxyurea

Hydroxyurea

12 NDCs across 9 manufacturers|6 Generic,6 Brand

Hydroxyurea is used to treat brain neoplasms, non-small-cell lung carcinoma, renal cell carcinoma, squamous cell carcinoma, head and neck neoplasms and hypereosinophilic syndrome, per the National Library of Medicine's MED-RT classification.

▸ More about this market

The brand product was first FDA-approved before 1982, and the first generic was approved Aug 18, 1995. FDA's Orange Book lists 5 AB-rated (therapeutically equivalent) products for this ingredient. In 2024, Medicare Part D spent $14 million on Hydroxyurea across 526,000 claims for 112,000 beneficiaries.

Hydroxyurea is available as 12 NDCs from 9 manufacturers (6 generic, 6 brand), with NADAC prices from $0.19 to $62.03 per EAthe most expensive product costs about 332× the cheapest. Every pack size and labeler in this drug market is compared side-by-side below.

Total NDCs

12

6G / 6B

Manufacturers

9

competing in market

Price Spread

$0.19 – $62.03

per EA, 11 of 12 NDCs

7d Activity

164 flat

avg -1.3% WoW · of 12 NDCs

Market Price Trend

Monthly average NADAC per unit, split by generic and brand.

Drug Portfolio

12 NDCs total, 12 shown

Frequently Asked Questions

What is Hydroxyurea used to treat?

Hydroxyurea is used to treat brain neoplasms, non-small-cell lung carcinoma, renal cell carcinoma, squamous cell carcinoma, head and neck neoplasms and hypereosinophilic syndrome, per the National Library of Medicine's MED-RT classification.

When did Hydroxyurea become available as a generic?

FDA approved the first generic Hydroxyurea (ANDA) on Aug 18, 1995. The Orange Book currently lists 5 AB-rated products for this ingredient, meaning FDA considers them therapeutically equivalent to the brand.

How much does Medicare spend on Hydroxyurea?

In 2024, Medicare Part D spent $14 million on Hydroxyurea across 526,000 claims for 112,000 beneficiaries.

How many Hydroxyurea products are on the market?

The Hydroxyurea drug market contains 12 NDCs from 9 manufacturers — 6 generic and 6 brand products.

What is the price range for Hydroxyurea?

NADAC reference prices for Hydroxyurea range from $0.1868 to $62.0318 per EA — the most expensive product costs about 332× the cheapest. 1 additional product is priced per a different unit (e.g. liquids per ML) and isn't directly comparable.

Is generic Hydroxyurea cheaper than brand?

The average generic NADAC for Hydroxyurea is $0.1868 per EA, versus $14.1002 for brand-labeled products — brand versions average about 75× the generic price.

Which manufacturers make Hydroxyurea?

9 manufacturers list Hydroxyurea in NADAC. Ranked by number of NDCs, the largest are H2-Pharma LLC (3), Medunik (2), Nova Laboratories, Ltd. (1), Somerset Therapeutics, LLC (1), Major Pharmaceuticals (1).

How has the price of Hydroxyurea changed recently?

Over the past 7 days, 1 Hydroxyurea NDC rose and 6 fell, with a market-wide average change of -1.3%.