Minocycline
Amzeeq, Arestin, Minocin, Minolira, Solodyn, Ximino, 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
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
respiratory tract diseases | D012140 |
eye diseases | D005128 |
urogenital diseases | D000091642 |
skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Amzeeq, Arestin, Minocin, Minolira, Solodyn, Ximino, Zilxi (generic drugs available since 1990-07-31)
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 |
SOLODYN | Bausch Health Companies | N-050808 RX | 2009-07-23 | 5 products, RLD, RS |
MINOLIRA | Novan | N-209269 RX | 2017-05-08 | 2 products, RS |
XIMINO | Journey Medical | N-201922 RX | 2012-07-11 | 3 products |
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 |
MINOCIN | REMPEX | N-050444 RX | 1982-01-01 | 1 products, RLD, RS |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
amzeeq | New Drug Application | 2023-01-25 |
arestin | New Drug Application | 2020-06-01 |
dynacin | ANDA | 2014-12-18 |
minocin | New Drug Application | 2021-03-18 |
minocycline hydrochloride | ANDA | 2023-06-19 |
minolira extended release | New Drug Application | 2019-09-04 |
solodyn | New Drug Application | 2017-09-12 |
ximino | New Drug Application | 2021-01-18 |
zilxi | New Drug Application | 2022-09-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
acne vulgaris | EFO_0003894 | D000152 | L70 |
anthrax | — | D000881 | A22 |
borrelia infections | EFO_1000842 | D001899 | — |
chancroid | — | D002602 | A57 |
cholera | — | D002771 | A00 |
escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
meningococcal infections | EFO_0004249 | D008589 | A39 |
mycoplasma infections | — | D009175 | — |
plague | EFO_0007481 | D010930 | A20 |
psittacosis | EFO_0007410 | D009956 | A70 |
Show 4 more
Agency Specific
FDA
EMA
No data
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
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 2 | 3 | 1 | 1 | 1 | 7 |
Low cardiac output | D002303 | 1 | 2 | 2 | 1 | 1 | 6 | ||
Cardiogenic shock | D012770 | R57.0 | 1 | — | — | 2 | — | 3 | |
Septic shock | D012772 | A48.3 | — | 1 | — | 1 | — | 2 | |
Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | — | — | 1 | — | 2 |
Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 1 | — | 1 | |
Pulmonary edema | D011654 | EFO_1001134 | J81 | — | — | — | 1 | — | 1 |
Hemodynamics | D006439 | — | — | — | 1 | — | 1 | ||
Anesthesia | D000758 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cardiac surgical procedures | D006348 | — | — | 1 | — | — | 1 | ||
Mitral valve insufficiency | D008944 | HP_0001653 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Heart failure | D006333 | EFO_0003144 | I50 | 4 | 3 | — | — | 1 | 6 |
Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 3 | — | — | — | 3 |
Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | 1 | — | — | 1 | 2 |
Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | 1 | — | — | 1 | 2 |
Intracranial vasospasm | D020301 | EFO_1000994 | G45.9 | — | 1 | — | — | 1 | 2 |
Right ventricular dysfunction | D018497 | 1 | 1 | — | — | — | 2 | ||
Cardio-renal syndrome | D059347 | — | 1 | — | — | — | 1 | ||
Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
Heart transplantation | D016027 | EFO_0010673 | — | 1 | — | — | — | 1 | |
Myocardial reperfusion injury | D015428 | EFO_0002687 | 1 | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 1 | 1 |
Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | — | — | — | 1 | 1 |
Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | — | 1 | 1 |
Physiologic monitoring | D008991 | — | — | — | — | 1 | 1 | ||
Hepatectomy | D006498 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | MINOCYCLINE |
INN | minocycline |
Description | Minocycline zwitterion is a zwitterion obtained by transfer of a proton from the 2-hydroxy group to the 1-amino group of minocycline. It is the major microspecies at pH 7.3 (according to Marvin v 6.2.0.). It is a zwitterion and an a tetracycline zwitterion. It is a conjugate acid of a minocycline(1-). It is a tautomer of a minocycline. |
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 | 6980 |
ChEMBL ID | CHEMBL1434 |
ChEBI ID | 50694 |
PubChem CID | 51537604 |
DrugBank | DB01017 |
UNII ID | FYY3R43WGO (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Amzeeq - Fortress Biotech, Inc.
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Minolira - Novan
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Minocin - MELINTA THERAPEUTICS, INC. /NEW/
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Ximino - Fortress Biotech, Inc.
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Ximino - Journey Medical
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Zilxi - Fortress Biotech, Inc.
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Safety
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Adverse Events
Top Adverse Reactions
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545 adverse events reported
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