Nuzyra generics — when can they launch?
Nuzyra (OMADACYCLINE TOSYLATE) · Paratek Pharms · 13 active US patents · 0 expired
Where Nuzyra sits in the generic timeline
Imminent generic cliff: earliest active US patent for Nuzyra expires in 2029 (~3 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 10 patents
- Formulation — 2 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Nuzyra patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2449 | (no description) |
U-1569 | (no description) |
U-2444 | (no description) |
U-2576 | (no description) |
Sample patent estate
Showing 6 of 13 active US patents. View full estate on the Nuzyra drug page →
-
This patent protects methods and compositions for using a tetracycline compound, specifically 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline, to treat bacterial infections.USPTO title: Minocycline compounds and methods of use thereof
-
This patent protects a method of treating bacterial infections, including MSSA, MRSA, and others, using the drug 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof.USPTO title: Minocycline compounds and methods of use thereof
-
This patent protects a method of treating bacterial infections, including MSSA, MRSA, and certain streptococci and enterococci, using the drug 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof.USPTO title: Minocycline compounds and methods of use thereof
-
This patent protects a method of treating bacterial infections, including MSSA, MRSA, and others, using the drug 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof.USPTO title: Minocycline compounds and methods of use thereof
-
This patent protects a method of treating bacterial infections, including MSSA, MRSA, and certain streptococci and enterococci, using the drug 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof.USPTO title: Minocycline compounds and methods of use thereof
-
This patent protects crystalline forms, including salts and polymorphs, of a compound useful in treating bacterial infections and other conditions responsive to tetracycline compounds.USPTO title: Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
Sources
- FDA Orange Book — patents listed against Nuzyra (NDA filed 2018)
- Nuzyra drug profile — full patent estate, indications, clinical trials, pricing
- Paratek Pharms patent portfolio
- Patent cliff 2029 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
Get generic entry alerts
Free Pharma CI alerts on Nuzyra — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →