FDA Orange Book · active-ingredient family
Larotrectinib sulfate
Larotrectinib sulfate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VITRAKVI · NDA 210861
2
Brand (NDA)
0
Generics (ANDA)
20
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VITRAKVIRLD×2 | BAYER HLTHCARE | NDA 210861 | — | Nov 26, 2018 | |
| VITRAKVIRLD | BAYER HEALTHCARE | NDA 211710 | — | Nov 26, 2018 |
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10047097 | Oct 21, 2029 | in 3 yr 5 mo | U-2474 |
| 8865698 | Oct 21, 2029 | in 3 yr 5 mo | U-2469 |
| 10005783 | Oct 21, 2029 | in 3 yr 5 mo | U-2472 |
| 9447104 | Oct 21, 2029 | in 3 yr 5 mo | U-2470 |
| 9676783 | Oct 21, 2029 | in 3 yr 5 mo | U-2469 |
| 10774085 | Oct 21, 2029 | in 3 yr 5 mo | U-2470 |
| 9127013 | Oct 21, 2029 | in 3 yr 5 mo | SubstanceProduct |
| 8513263 | Dec 23, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 9782414 | Nov 16, 2035 | in 9 yr 7 mo | U-2475 |
| 10285993 | Nov 16, 2035 | in 9 yr 7 mo | U-2470 |
| 10813936 | Nov 16, 2035 | in 9 yr 7 mo | U-2987 |
| 10172861 | Nov 16, 2035 | in 9 yr 7 mo | SubstanceProduct |
| 10799505 | Aug 15, 2036 | in 10 yr 4 mo | SubstanceProduct |
| 10045991 | Apr 04, 2037 | in 10 yr 11 mo | U-2473 |
| 11484535 | Apr 04, 2037 | in 10 yr 11 mo | U-2470 |
| 11191766 | Apr 04, 2037 | in 10 yr 11 mo | U-2471 |
| 10668072 | Apr 04, 2037 | in 10 yr 11 mo | Product |
| 10137127 | Apr 04, 2037 | in 10 yr 11 mo | Product |
| 11974998 | May 16, 2037 | in 11 yr 1 mo | U-4124 |
| 11337967 | May 16, 2037 | in 11 yr 1 mo | U-4123 |
Larotrectinib sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
