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  1. pharmadog
  2. ›drugs
  3. ›Nuzyra
drug · small molecule
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omadacycline tosylate

Marketedupdated 3mo ago
by Paratek Pharmaceuticals Inc🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for skin disease and bacterial pneumonia and 1 investigational indication.

targets

Bacterial 70S ribosome

all catalysts(0)

nothing on the calendar yet

Trials studying omadacycline tosylate

  • phase1Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infectionscompletedn=23
  • phase4Pharmacokinetics of Omadacycline in Cystic Fibrosiscompletedn=9

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 2, 2028
~2.1 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (13)

  • Oct 31, 2037method-of-use (U-2576)US 10383884
  • Oct 31, 2037method-of-use (U-2576)US 10383884
  • Oct 31, 2037method-of-use (U-2576)US 10835542
  • Oct 31, 2037method-of-use (U-2576)US 10835542
  • Aug 3, 2037method-of-use (U-2444)US 10111890
  • Mar 18, 2031formulationUS 93144754.6y
  • Oct 24, 2030formulationUS 92657404.2y
  • Sep 23, 2030compositionUS 83836104.1y
  • Mar 5, 2029method-of-use (U-2449)US 101240142.6y
  • Mar 5, 2029method-of-use (U-2449)US 101240142.6y
  • Mar 5, 2029formulationUS 92657402.6y
  • Mar 5, 2029method-of-use (U-1569)US 97243582.6y
  • Mar 5, 2029method-of-use (U-1569)US 97243582.6y

FDA exclusivities (4)

  • Oct 2, 2028GAINGAIN Antibiotic (5y)2.1y
  • Oct 2, 2028GAINGAIN Antibiotic (5y)2.1y
  • Oct 2, 2023NCENew Chemical Entity (5y)
  • Oct 2, 2023NCENew Chemical Entity (5y)

News(0)

no news has mentioned this drug yet

brand
Nuzyra
trade names
Nuzyra
generic
omadacycline tosylate
MOA
Bacterial 70S ribosome inhibitor
indication
Mycobacterium Infections
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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