FDA Orange Book · active-ingredient family
Omadacycline tosylate
Omadacycline tosylate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NUZYRA · NDA 209817
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
4
Exclusivity periods
Brand (NDA) products · powder, tablet
Marketing exclusivity (4)
- NCENew chemical entity exclusivity (5 years)
Oct 02, 2023
2 yr 9 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Oct 02, 2028
in 2 yr 4 mo
- NCENew chemical entity exclusivity (5 years)
Oct 02, 2023
2 yr 9 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Oct 02, 2028
in 2 yr 4 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10124014 | Mar 05, 2029 | in 2 yr 9 mo | U-2449 |
| 9724358 | Mar 05, 2029 | in 2 yr 9 mo | U-1569 |
| 9265740 | Mar 05, 2029 | in 2 yr 9 mo | Product |
| 8383610 | Sep 23, 2030 | in 4 yr 4 mo | Substance |
| 9314475 | Mar 18, 2031 | in 4 yr 10 mo | Product |
| 10111890 | Aug 03, 2037 | in 11 yr 3 mo | U-2444 |
| 10383884 | Oct 31, 2037 | in 11 yr 6 mo | U-2576 |
| 10835542 | Oct 31, 2037 | in 11 yr 6 mo | U-2576 |
Omadacycline tosylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
