Minocycline
Amzeeq, Arestin, Minocin, Minocycline, Zilxi (minocycline) is a small molecule pharmaceutical. Minocycline was first approved as Minocin on 1982-01-01. It is used to treat acne vulgaris, anthrax, borrelia infections, chancroid, and cholera amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Amzeeq, Arestin, Minocin, Minocycline, Zilxi (discontinued: Dynacin, Minocin, Minocycline, Minolira, Solodyn, Ximino)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Minocycline hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MINOCIN | Bausch Health Companies | N-050649 RX | 1990-05-31 | 2 products, RLD |
| AMZEEQ | Journey Medical | N-212379 RX | 2019-10-18 | 1 products, RLD, RS |
| ZILXI | Journey Medical | N-213690 RX | 2020-05-28 | 1 products, RLD, RS |
| ARESTIN | Orapharma | N-050781 RX | 2001-02-16 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amzeeq | New Drug Application | 2023-01-25 |
| arestin | New Drug Application | 2024-05-31 |
| dynacin | ANDA | 2014-12-18 |
| minocin | New Drug Application | 2021-07-28 |
| minocycline | ANDA | 2024-07-08 |
| minocycline hydrochloride | ANDA | 2024-10-21 |
| minolira extended release | New Drug Application | 2022-11-02 |
| solodyn | New Drug Application | 2011-04-04 |
| zilxi | New Drug Application | 2024-02-09 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Minocycline Hydrochloride, Amzeeq, Journey | |||
| 10398641 | 2037-09-08 | U-2647 | |
| 10849847 | 2037-09-08 | U-2647 | |
| 8865139 | 2030-10-01 | DP | U-1631, U-2647 |
| 8945516 | 2030-10-01 | DP | |
| 8992896 | 2030-10-01 | DP | U-1631, U-2647 |
| 9675700 | 2030-10-01 | DP | U-1631, U-2647 |
| 10086080 | 2030-10-01 | U-2647 | |
| 10137200 | 2030-10-01 | U-2647 | |
| 10213512 | 2030-10-01 | DP | U-1631, U-2647 |
| 10265404 | 2030-10-01 | DP | |
| 10517882 | 2030-10-01 | U-2647 | |
| 10821187 | 2030-10-01 | U-2647 | |
| Minocycline Hydrochloride, Minolira, Epi Hlth | |||
| 11103517 | 2036-04-07 | DP | |
| Minocycline Hydrochloride, Solodyn, Bausch | |||
| 9192615 | 2031-11-17 | DP | |
| 7541347 | 2027-04-02 | U-917 | |
| 7544373 | 2027-04-02 | DP | |
| 7919483 | 2027-03-07 | U-124, U-1078 | |
| 7790705 | 2025-06-24 | U-124, U-1078 | |
| 8252776 | 2025-06-24 | U-124 | |
| 8268804 | 2025-06-24 | U-124, U-1078 | |
| 8722650 | 2025-06-24 | U-1078 | |
| Minocycline Hydrochloride, Minocin, Rempex | |||
| 9084802 | 2031-05-12 | U-282 | |
| 9278105 | 2031-05-12 | U-282 | |
| Minocycline Hydrochloride, Zilxi, Journey | |||
| 10322186 | 2030-10-01 | U-1631 | |
| 10946101 | 2030-10-01 | U-1631 | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB23: Minocycline
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AF: Antiinfectives for treatment of acne
— D10AF07: Minocycline
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01A: Tetracycline antibiotics
— J01AA: Tetracyclines
— J01AA08: Minocycline
HCPCS
Code | Description |
|---|---|
| J2265 | Injection, minocycline hydrochloride, 1 mg |
Clinical
Clinical Trials
296 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Minocycline |
| INN | minocycline |
| Description | Minocycline is a tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5. It has a role as an antibacterial drug, an Escherichia coli metabolite and a geroprotector. It is a member of tetracyclines, a tetracenomycin and a tertiary alpha-hydroxy ketone. It is a conjugate acid of a minocycline(1-). It is a tautomer of a minocycline zwitterion. |
| Classification | Small molecule |
| Drug class | antibiotics (tetracycline derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)c1ccc(O)c2c1C[C@H]1C[C@H]3[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C2=O |
Identifiers
| PDB | — |
| CAS-ID | 10118-90-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1434 |
| ChEBI ID | 50694 |
| PubChem CID | 54675783 |
| DrugBank | DB01017 |
| UNII ID | FYY3R43WGO (ChemIDplus, GSRS) |
Target
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Minocin – Melinta Therapeutics /new/
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Ximino – Fortress Biotech
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Ximino – Journey Medical
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Amzeeq – Fortress Biotech
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Amzeeq – Journey Medical
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Minolira – Novan
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Zilxi – Fortress Biotech
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Zilxi – Journey Medical
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Tabular view
Estimated US medical usage
Minocycline
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 33,136 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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8,837 adverse events reported
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