Orange Book product · Brand (NDA)
OFIRMEV
ACETAMINOPHEN
At a glance
Nov 02, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 02, 2010
15 yr 10 mo ago
Today
Patent 10383834 expires
Listed method-of-use patent (U-2262) expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10383834 expires
Listed method-of-use patent (U-2621) expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 9610265 expires
Listed method-of-use patent (U-2263) expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 9987238 expires
Listed method-of-use patent (U-2261) expiration.
Nov 13, 2028
in 2 yr 5 mo
Patent 10383834*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 9610265*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 9987238*PED expires
Listed listed patent expiration.
May 13, 2029
in 2 yr 11 mo
Patent 9399012 expires
Listed method-of-use patent (U-2262) expiration.
Sep 11, 2031
in 5 yr 4 mo
Patent 9399012 expires
Listed method-of-use patent (U-2261) expiration.
Sep 11, 2031
in 5 yr 4 mo
Patent 9399012*PED expires
Listed listed patent expiration.
Mar 11, 2032
in 5 yr 10 mo
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN
Strength
1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 022450
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2022ACETAMINOPHENBrand (NDA)
NDA 206968 · HIKMA
- 2021ACETAMINOPHENBrand (NDA)
NDA 204957 · B BRAUN MEDICAL
- 2021ACETAMINOPHENBrand (NDA)
NDA 206610 · RISING
- 2015ACETAMINOPHENBrand (NDA)
NDA 204767 · FRESENIUS KABI USA
- 1994TYLENOLBrand (NDA)
NDA 019872 · KENVUE BRANDS
- 1986INJECTAPAPBrand (NDA)
NDA 017785 · ORTHO MCNEIL PHARM
- 1983ACETAMINOPHENBrand (NDA)
NDA 018337 · TARO
- —ACEPHENBrand (NDA)
NDA 018060 · COSETTE
- —NEOPAPBrand (NDA)
NDA 016401 · POLYMEDICA
- —TYLENOLBrand (NDA)
NDA 017756 · J AND J CONSUMER INC
- 2025ACETAMINOPHENGeneric (ANDA)
ANDA 219096 · CAPLIN
- 2025ACETAMINOPHENGeneric (ANDA)
ANDA 219215 · GLAND
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10383834 | Nov 13, 2028 | in 2 yr 5 mo | U-2262 |
| 10383834 | Nov 13, 2028 | in 2 yr 5 mo | U-2621 |
| 9610265 | Nov 13, 2028 | in 2 yr 5 mo | U-2263 |
| 9987238 | Nov 13, 2028 | in 2 yr 5 mo | U-2261 |
| 10383834*PED | May 13, 2029 | in 2 yr 11 mo | |
| 9610265*PED | May 13, 2029 | in 2 yr 11 mo | |
| 9987238*PED | May 13, 2029 | in 2 yr 11 mo | |
| 9399012 | Sep 11, 2031 | in 5 yr 4 mo | U-2262 |
| 9399012 | Sep 11, 2031 | in 5 yr 4 mo | U-2261 |
| 9399012*PED | Mar 11, 2032 | in 5 yr 10 mo |
