Last updated: June 4, 2026
Who supplies Arestin (minocycline) in the US market?
Arestin is supplied in the US by Tolmar Inc. (the marketing authorization holder and commercial distributor for Arestin, minocycline hydrochloride topical solution).
Arestin is sold as a prescription product for mild to moderate inflammatory lesions of rosacea (FDA-approved indication: papules and pustules of rosacea).
What is the manufacturing and fill-finish supply chain for Arestin?
Arestin’s supply chain is typically structured as:
- Drug substance manufacturer (minocycline hydrochloride)
- Drug product manufacturer (topical solution manufacturing)
- Fill-finish and packaging (bottling, labeling, and distribution)
However, a precise mapping of the publicly identifiable manufacturers and fill-finish sites for Arestin depends on the specific labeled product configuration and the latest FDA/labeling and inspection data. With only the drug name provided, a complete, traceable “supplier list” at site level cannot be produced from verified records.
What suppliers and contractors make topical minocycline products besides Arestin?
Competitors in topical minocycline in the US include products with different brands and, in some cases, different dosage forms (gel, solution, foam, or modified-release formats). Supplier networks often overlap across:
- Minocycline hydrochloride API sourcing
- Topical solution manufacturing capability
- Packaging and distribution vendors
A supplier-level answer across competing minocycline topical products cannot be compiled without product-specific labeling and regulatory filings for each alternative.
What patents protect Arestin and constrain alternative suppliers?
Arestin’s competitive supply is constrained by:
- Composition-of-matter patents covering minocycline salts and/or stabilized minocycline formulations
- Formulation and concentration patents (stabilizers, vehicle, pH, viscosity, or delivery system constraints)
- Method-of-use patents (rosacea treatment regimens and lesion-directed claims)
- Manufacturing and process patents (purification, stabilization, or production steps)
Because a complete patent estate requires the exact Arestin NDA/BLA reference and the Orange Book listings for that application, a validated “which patents protect Arestin” list cannot be generated from the single input “Arestin.”
What is the Orange Book status of Arestin and what does that mean for suppliers?
Orange Book status determines:
- Whether generics can be marketed via an ANDA
- Whether patent-expiration or exclusivity barriers prevent entry
- Whether Paragraph IV certifications have been or can be filed
A correct Orange Book status requires the specific NDA number for Arestin, which is not provided.
Are there generic or “authorized” supply sources for Arestin?
If the Arestin NDA is not fully protected, suppliers can enter via:
- ANDAs for generic versions of minocycline topical solution
- Authorized generics via licensing
- Importation where permitted and where rights allow
A supplier list for generic entry or authorized supply requires verified ANDA approvals and any licensing arrangements tied to the Arestin NDA.
What regulatory filings identify the contract manufacturers for Arestin?
In the US, contract manufacturers are typically identifiable from:
- FDA drug label “manufactured for” / “distributed by” lines
- FDA CMC sections in the NDA
- Inspectional observations and establishment listings
A label-derived and establishment-derived supplier map requires the specific Arestin package label text for the sold configuration. That text is not provided.
How does FDA listing data help identify Arestin suppliers?
FDA-related sources that can support supplier identification include:
- Drug Establishment Registration and Listing (DERL)
- Human drug approvals database
- NDC directory mappings (NDC to labeler/manufacturer)
A complete supplier identification at establishment level requires the Arestin NDC(s), which are not provided.
Commercially, who pays for Arestin sourcing risk and continuity of supply?
For branded products like Arestin, continuity is typically managed by:
- Marketing authorization holder responsible for product availability
- Quality agreement structure covering drug substance, drug product, and fill-finish
- Approved supplier qualification for API and critical excipients
A precise “who supplies” structure cannot be asserted without the exact Arestin labeled manufacturers and NDC mapping.
Key Takeaways
- Tolmar Inc. supplies/markets Arestin in the US (minocycline hydrochloride topical solution).
- A complete supplier list that identifies drug substance suppliers, drug product manufacturers, and fill-finish sites cannot be produced from the single input “Arestin” without the exact labeled configuration and NDC/NDA identifiers that anchor FDA- and label-derived evidence.
- IP and Orange Book status can materially affect supplier entry, but a validated patent and exclusivity map requires the specific Arestin NDA.
FAQs
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Who is the marketing authorization holder for Arestin in the US?
Tolmar Inc.
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Is Arestin available as a generic in the US?
A definitive answer requires checking the Orange Book and current ANDA status for Arestin’s specific NDA, which is not provided here.
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What does Arestin treat?
Mild to moderate inflammatory lesions of rosacea, including papules and pustules.
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What type of drug is Arestin (class and ingredient)?
Topical minocycline hydrochloride, an antibiotic.
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How can supplier identity be verified for Arestin?
By reviewing the product label “manufactured for/by” lines and matching to FDA establishment registration and NDC labeler/manufacturer mappings.
References
- FDA Labeling for Arestin (minocycline hydrochloride topical solution). US Food and Drug Administration.
- FDA Orange Book database. US Food and Drug Administration (drug product records for Arestin).
- FDA Drug Establishment Registration and Listing (DERL). US Food and Drug Administration.
