Orange Book product · Brand (NDA)
VABOMERE
MEROPENEM; VABORBACTAM
At a glance
Aug 29, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2017
8 yr 11 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 29, 2022
3 yr 10 mo ago
Today
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Aug 29, 2027
in 1 yr 3 mo
Patent 10172874 expires
Listed drug product patent expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 10183034 expires
Listed method-of-use patent (U-2490) expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 10561675 expires
Listed method-of-use patent (U-2490) expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 11007206 expires
Listed method-of-use patent (U-3128) expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 12171772 expires
Listed drug substance patent expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 9694025 expires
Listed method-of-use patent (U-2120) expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 8680136 expires
Listed drug substance patent expiration.
Aug 29, 2031
in 5 yr 3 mo
Patent 12478606 expires
Listed method-of-use patent (U-3421) expiration.
Jan 08, 2038
in 11 yr 9 mo
Patent 11376237 expires
Listed method-of-use patent (U-3421) expiration.
Apr 06, 2039
in 13 yr
Patent 12533342 expires
Listed method-of-use patent (U-3421) expiration.
May 20, 2039
in 13 yr 1 mo
Pharmaceutical detail
Active ingredient
MEROPENEM; VABORBACTAM
Strength
1GM/VIAL;1GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 209776
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Aug 29, 2022
3 yr 10 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Aug 29, 2027
in 1 yr 3 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10172874 | Aug 08, 2031 | in 5 yr 3 mo | Product |
| 10183034 | Aug 08, 2031 | in 5 yr 3 mo | U-2490 |
| 10561675 | Aug 08, 2031 | in 5 yr 3 mo | U-2490 |
| 11007206 | Aug 08, 2031 | in 5 yr 3 mo | U-3128 |
| 12171772 | Aug 08, 2031 | in 5 yr 3 mo | Substance |
| 9694025 | Aug 08, 2031 | in 5 yr 3 mo | U-2120 |
| 8680136 | Aug 29, 2031 | in 5 yr 3 mo | SubstanceProduct |
| 12478606 | Jan 08, 2038 | in 11 yr 9 mo | U-3421 |
| 11376237 | Apr 06, 2039 | in 13 yr | U-3421 |
| 12533342 | May 20, 2039 | in 13 yr 1 mo | U-3421 |
