Isotretinoin
64 NDCs across 11 manufacturers|58 Generic,6 Brand
Isotretinoin is used to treat acne vulgaris, leukemia and neuroblastoma, per the National Library of Medicine's MED-RT classification.
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The brand product was first FDA-approved on May 7, 1982, and the first generic was approved Nov 8, 2002. FDA's Orange Book lists 55 AB-rated (therapeutically equivalent) products for this ingredient. In 2024, Medicare Part D spent $3 million on Isotretinoin across 17,000 claims for 6,848 beneficiaries.
Isotretinoin is available as 64 NDCs from 11 manufacturers (58 generic, 6 brand), with NADAC prices from $1.93 to $42.42 per EA — the most expensive product costs about 22× the cheapest. Every pack size and labeler in this drug market is compared side-by-side below.
Total NDCs
64
58G / 6B
Manufacturers
11
competing in market
Price Spread
$1.93 – $42.42
per EA
7d Activity
avg +1.6% WoW · of 64 NDCs
Market Price Trend
Monthly average NADAC per unit, split by generic and brand.
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Top supplier
Sun Pharmaceutical Industries Inc. manufacturer profile
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Lead class
Retinoid class view
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Trend hub
Latest market trends
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Guide
How to interpret NADAC
Review the benchmark methodology behind the prices and spreads shown on this market page.
Manufacturer Breakdown
11 manufacturers producing ISOTRETINOIN(1 pricing outlier)
Frequently Asked Questions
What is Isotretinoin used to treat?
Isotretinoin is used to treat acne vulgaris, leukemia and neuroblastoma, per the National Library of Medicine's MED-RT classification.
When did Isotretinoin become available as a generic?
FDA approved the first generic Isotretinoin (ANDA) on Nov 8, 2002. The Orange Book currently lists 55 AB-rated products for this ingredient, meaning FDA considers them therapeutically equivalent to the brand.
How much does Medicare spend on Isotretinoin?
In 2024, Medicare Part D spent $3 million on Isotretinoin across 17,000 claims for 6,848 beneficiaries.
How many Isotretinoin products are on the market?
The Isotretinoin drug market contains 64 NDCs from 11 manufacturers — 58 generic and 6 brand products.
What is the price range for Isotretinoin?
NADAC reference prices for Isotretinoin range from $1.9325 to $42.4239 per EA — the most expensive product costs about 22× the cheapest.
Is generic Isotretinoin cheaper than brand?
The average generic NADAC for Isotretinoin is $4.1418 per EA, versus $39.2058 for brand-labeled products — brand versions average about 9.5× the generic price.
Which manufacturers make Isotretinoin?
11 manufacturers list Isotretinoin in NADAC. Ranked by number of NDCs, the largest are Sun Pharmaceutical Industries Inc. (11), Upsher-Smith Laboratories LLC (8), Mayne Pharma (8), Teva Pharmaceuticals USA Inc. (7), Actavis Pharma, Inc. (5).
How has the price of Isotretinoin changed recently?
Over the past 7 days, 33 Isotretinoin NDCs rose and 22 fell, with a market-wide average change of +1.6%.