Orange Book product · Brand (NDA)
VITRAKVI
LAROTRECTINIB SULFATE
At a glance
Nov 26, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 26, 2018
7 yr 8 mo ago
Today
Patent 10005783 expires
Listed method-of-use patent (U-2472) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 10047097 expires
Listed method-of-use patent (U-2474) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 10774085 expires
Listed method-of-use patent (U-2470) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 8865698 expires
Listed method-of-use patent (U-2469) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 9127013 expires
Listed drug substance patent expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 9447104 expires
Listed method-of-use patent (U-2470) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 9676783 expires
Listed method-of-use patent (U-2469) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent 8513263 expires
Listed drug substance patent expiration.
Dec 23, 2029
in 3 yr 7 mo
Patent 10172861 expires
Listed drug substance patent expiration.
Nov 16, 2035
in 9 yr 7 mo
Patent 9782414 expires
Listed method-of-use patent (U-2471) expiration.
Nov 16, 2035
in 9 yr 7 mo
Patent 10799505 expires
Listed drug substance patent expiration.
Aug 15, 2036
in 10 yr 4 mo
Patent 10045991 expires
Listed method-of-use patent (U-2473) expiration.
Apr 04, 2037
in 10 yr 11 mo
Patent 10137127 expires
Listed drug product patent expiration.
Apr 04, 2037
in 10 yr 11 mo
Patent 10668072 expires
Listed drug product patent expiration.
Apr 04, 2037
in 10 yr 11 mo
Patent 11191766 expires
Listed method-of-use patent (U-2471) expiration.
Apr 04, 2037
in 10 yr 11 mo
Patent 11484535 expires
Listed method-of-use patent (U-2470) expiration.
Apr 04, 2037
in 10 yr 11 mo
Patent 11337967 expires
Listed method-of-use patent (U-4123) expiration.
May 16, 2037
in 11 yr 1 mo
Patent 11974998 expires
Listed method-of-use patent (U-4124) expiration.
May 16, 2037
in 11 yr 1 mo
Pharmaceutical detail
Active ingredient
LAROTRECTINIB SULFATE
Strength
EQ 20MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 211710
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 (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10005783 | Oct 21, 2029 | in 3 yr 5 mo | U-2472 |
| 10047097 | Oct 21, 2029 | in 3 yr 5 mo | U-2474 |
| 10774085 | Oct 21, 2029 | in 3 yr 5 mo | U-2470 |
| 8865698 | Oct 21, 2029 | in 3 yr 5 mo | U-2469 |
| 9127013 | Oct 21, 2029 | in 3 yr 5 mo | SubstanceProduct |
| 9447104 | Oct 21, 2029 | in 3 yr 5 mo | U-2470 |
| 9676783 | Oct 21, 2029 | in 3 yr 5 mo | U-2469 |
| 8513263 | Dec 23, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 10172861 | Nov 16, 2035 | in 9 yr 7 mo | Substance |
| 9782414 | Nov 16, 2035 | in 9 yr 7 mo | U-2471 |
| 10799505 | Aug 15, 2036 | in 10 yr 4 mo | Substance |
| 10045991 | Apr 04, 2037 | in 10 yr 11 mo | U-2473 |
| 10137127 | Apr 04, 2037 | in 10 yr 11 mo | Product |
| 10668072 | Apr 04, 2037 | in 10 yr 11 mo | Product |
| 11191766 | Apr 04, 2037 | in 10 yr 11 mo | U-2471 |
| 11484535 | Apr 04, 2037 | in 10 yr 11 mo | U-2470 |
| 11337967 | May 16, 2037 | in 11 yr 1 mo | U-4123 |
| 11974998 | May 16, 2037 | in 11 yr 1 mo | U-4124 |
