Orange Book product · Brand (NDA)
TYMLOS
ABALOPARATIDE
At a glance
Apr 28, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2017
9 yr 3 mo ago
Today
Patent 8748382 expires
Listed method-of-use patent (U-3543) expiration.
Oct 03, 2027
in 1 yr 4 mo
Patent 8748382 expires
Listed method-of-use patent (U-2009) expiration.
Oct 03, 2027
in 1 yr 4 mo
Patent 8148333 expires
Listed drug product patent expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 7803770 expires
Listed method-of-use patent (U-2009) expiration.
Apr 28, 2031
in 4 yr 11 mo
Patent RE49444 expires
Listed method-of-use patent (U-2009) expiration.
Apr 28, 2031
in 4 yr 11 mo
Patent RE49444 expires
Listed method-of-use patent (U-3543) expiration.
Apr 28, 2031
in 4 yr 11 mo
Patent 10996208 expires
Listed drug product patent expiration.
Apr 30, 2038
in 12 yr
Patent 11782041 expires
Listed drug product patent expiration.
Apr 30, 2038
in 12 yr
Patent 11782041 expires
Listed drug product patent expiration.
Apr 30, 2038
in 12 yr
Patent 11977067 expires
Listed drug product patent expiration.
Apr 30, 2038
in 12 yr
Patent 11255842 expires
Listed method-of-use patent (U-3322) expiration.
Jan 10, 2040
in 13 yr 9 mo
Patent 11680942 expires
Listed method-of-use patent (U-3322) expiration.
Jan 10, 2040
in 13 yr 9 mo
Pharmaceutical detail
Active ingredient
ABALOPARATIDE
Strength
3.12MG/1.56ML (2MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 208743
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.
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8748382 | Oct 03, 2027 | in 1 yr 4 mo | U-3543 |
| 8748382 | Oct 03, 2027 | in 1 yr 4 mo | U-2009 |
| 8148333 | Nov 08, 2027 | in 1 yr 5 mo | Product |
| 7803770 | Apr 28, 2031 | in 4 yr 11 mo | U-2009 |
| RE49444 | Apr 28, 2031 | in 4 yr 11 mo | U-2009 |
| RE49444 | Apr 28, 2031 | in 4 yr 11 mo | U-3543 |
| 10996208 | Apr 30, 2038 | in 12 yr | Product |
| 11782041 | Apr 30, 2038 | in 12 yr | ProductU-2009 |
| 11782041 | Apr 30, 2038 | in 12 yr | ProductU-3543 |
| 11977067 | Apr 30, 2038 | in 12 yr | Product |
| 11255842 | Jan 10, 2040 | in 13 yr 9 mo | U-3322 |
| 11680942 | Jan 10, 2040 | in 13 yr 9 mo | U-3322 |
