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Nuzyra (OMADACYCLINE TOSYLATE)
Nuzyra works by inhibiting protein synthesis in bacteria, ultimately leading to their death.
Omadacycline tosylate (Nuzyra), marketed by Paratek Pharmaceuticals, is an advanced tetracycline antibiotic indicated for the treatment of community-acquired bacterial pneumonia (CABP). Its key strength lies in its mechanism of action, which effectively inhibits bacterial protein synthesis, offering a potent alternative to older tetracyclines like demeclocycline and doxycycline. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | OMADACYCLINE TOSYLATE |
|---|---|
| Sponsor | Paratek Pharms |
| Drug class | Tetracycline-class Antibacterial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
NUZYRA is an antibacterial drug [see Microbiology (12.4)].
Approved indications
- Community-Acquired Bacterial Pneumonia (CABP)
- Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Common side effects
- Alanine aminotransferase increased
- Hypertension
- Gamma-glutamyl transferase increased
- Insomnia
- Vomiting
- Constipation
- Nausea
- Aspartate aminotransferase increased
- Headache
- Diarrhea
- Fatigue
- Dizziness
Drug interactions
- Anticoagulant Drugs
- Antacids containing aluminum, calcium, or magnesium
- Bismuth subsalicylate
- Iron-containing preparations
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10111890 | 2037-08-03 | Method of Use |
| 8383610 | 2030-09-23 | Compound |
| 9314475 | 2031-03-18 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nuzyra CI brief — competitive landscape report
- Nuzyra updates RSS · CI watch RSS
- Paratek Pharms portfolio CI