Icon

Rydapt - (25 mg; Capsule, Oral)

Midostaurin Novartis
25 mg; Capsule, Oral
Less Than $1000 mn
Less Than 5
Less Than 5
More Than 5
Less Than 5
Less Than 5
None
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: • Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutationpositive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation (1.1). Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. • Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2)
Yes
**** ******* **. *****'* *** **** *********. **, **. ***** *** ****** **** ********. ***** ** ******* *********** *** ***** **** ** ******. *** ******-***** **** ** **** **** (**** **. *****'*) ***** ****** ** ******* **** ******** **, ****. *** ********** **** ********** ******** ** *** ******** ******* ******** ******* ** ******* **** ******* **, **** (***** *** ***-**** ***** **** *** *** ******** ** ***** **, ****). *** ** *.*.*. § ***(*)(*)(*)(**).
Rydapt Patent 1 Patent 2 Patent 3
***** ****** ******* ******* *******
***** *** ********* *** ********* *******
** *****'* ******* *** ********* *** *********
Company FTF Status / 180 days exclusivity 30-Months stay Current Litigation Status Current Approval Status Likelihood of launch
***** ****** ***\ ********* *** **, **** ******* ********* ******** ******* *** **** *** *** ****
** *****'* ***\ ********* *** **, **** ******* ******** ******* *** **** *** *** ****
***** ***\ ********* *** **, **** ******* ******** ******* *** **** *** *** ****
  1. *** **, **** : ******** **** ** *****'* ** ****** '*** (*** **,****) *** ***** ** ****** '*** (*** *, ****).
  2. *** **, **** : ******** **** ***** *** **** ** ******* '***(*** **, ****), '*** (*** **, ****) *** '*** (*** *, ****).
  3. *** **, **** : ******** ********* **** ******* ** *****'*
  4. *** **, **** : ****** (*****) ******** ******** ***** *** **** ** ****** **** ****** '*** (*** **, ****)
  5. *** *, **** : ******** ******* **** ***** ** ****** ******* ** ******* *****.
  6. *** *, **** : ******** **** ****** (*****) **** ************ ** ****** '*** (*** **, ****)
  7. *** **, **** : ******** ********* ********** ******* ****** (*****). ** ****** ********* ** ** ****** ** ****** (*****)
  8. *** **, **** : ********* ** **'* ******* *********, **** ****** ************ ** ****** '*** *** '***. ******** *** **** **** ******* *********** **** ******* *****.
  9. *** *, **** : ********* ** **'* ******* *********, **** ****** ************ ** ****** '*** *** '***. ******** *** **** **** ******* *********** **** ******* *****.
  10. *** *, **** : ********* ** **'* ******* *********, ***** ****** ************ ** ****** '***. ******** *** **** **** ******* *********** **** ******* *****.
  11. *** **, **** : ********* ** **'* ******* *********, **. ****** ****** ************ ** ****** '***. ******** *** **. ****** **** ******* *********** **** ******* *****.
  12. *** **, **** : ******** *** ***** ****** **** ******* ********** **** ******* *****.
  13. *** **, **** : ******** *** ****** (*****) **** ******* ********** **** ******* *****.

Download ParaIV Report


Download ParaIV Detailed Report


To get detailed report Contact Us

ParaIV Advanced Search






Drug Name Generic Name Dosage Route of Administration Probable FTF Known Para IV Filers Other ANDA Developers

Please contact contact@researchdelta.com to get more details.