| Zanubrutinib | Beigene | ||
| 80 mg ; Capsule |
More Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
None | ||
| None | None | ||
| BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. Waldenström’s macroglobulinemia (WM). Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. | |||
|
Yes
| |||
| Brukinsa | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| *********** ********[*,*-*]*********** ** ******'* ******** ****** ********** | *********** ********[*,*-*]*********** ** ******'* ******** ****** ********** | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****-*************[*,*-*]**********-*-***********, ***********, *** **** ******* | *********** ********[*,*-*]*********** ** ******'* ******** ****** ********** | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****- *************[*,*-*]**********-*-***********, ***********, *** **** ******* | ********* ** * **** ******* ***** * *********** ********** *** ********** | ******* ** ******** *-**** ************* ******** | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****-*************[*,*-*]**********-*-***********, ***********, *** **** ******* | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****- *************[*,*-*]**********-*-***********, ***********, *** **** ******* | ******* ** ******** *-**** ************* ******** | ******* ** ******** *-**** ************* ******** | *********** **** ** (*)-*-(*-*****************-*-**)- *-(*-*************)-*,*,*,*-*****- *************[*,*-*]**********-*-***********, ***********, *** **** ******* |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| *** **** | *** \ ********* | *** **, **** | ******* | **** | ** **** **, **** |
| ****** | *** \ ********* | *** **, **** | ******* | **** | ****** ** **** **, **** |
| Zanubrutinib | BeOne Medicines USA Inc. | ||
| 160 mg ; Tablets |
More Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
None | ||
| None | None | ||
| None | |||
|
No
| |||
| Brukinsa | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 | Patent 13 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ***** ****** | **** *** | **** *** | **** ** *** **, **** | **** *** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** |
| *********** ********[*,*-*]*********** ** ******'* ******** ****** ********** | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****-*************[*,*-*]**********-*-***********, ***********, *** **** ******* | *********** ********[*,*-*]*********** ** ******'* ******** ****** ********** | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****- *************[*,*-*]**********-*-***********, ***********, *** **** ******* | ********* ** * **** ******* ***** * *********** ********** *** ********** | ******* ** ******** *-**** ************* ******** | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****-*************[*,*-*]**********-*-***********, ***********, *** **** ******* | *********** **** ** (*)-*-(*-*****************-*-**)-*-(*-*************)-*,*,*,*-*****- *************[*,*-*]**********-*-***********, ***********, *** **** ******* | ******* ** ******** *-**** ************* ******** | ******* ** ******** *-**** ************* ******** | *********** **** ** (*)-*-(*-*****************-*-**)- *-(*-*************)-*,*,*,*-*****- *************[*,*-*]**********-*-***********, ***********, *** **** ******* | **** ***** ****** ********** ******'* ******** ****** ********* *** *********** ****** ******** |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ***** ****** | *** \ ********* | *** **, **** | ******* | **** | *** ****** *** **** (******** ******) |
Download ParaIV Report
| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
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