| Icosapent Ethyl | Amarin | ||
| 1gm; Capsule, Oral |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
None | ||
|
More Than 5
|
More Than 5
|
||
| Indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( ≥ 500 mg/dL) hypertriglyceridemia. | |||
|
Yes
| |||
| Vascepa | 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 | Patent 14 | Patent 15 | Patent 16 | Patent 17 | Patent 18 | Patent 19 | Patent 20 | Patent 21 | Patent 22 | Patent 23 | Patent 24 | Patent 25 | Patent 26 | Patent 27 | Patent 28 | Patent 29 | Patent 30 | Patent 31 | Patent 32 | Patent 33 | Patent 34 | Patent 35 | Patent 36 | Patent 37 | Patent 38 | Patent 39 | Patent 40 | Patent 41 | Patent 42 | Patent 43 | Patent 44 | Patent 45 | Patent 46 | Patent 47 | Patent 48 | Patent 49 | Patent 50 | Patent 51 | Patent 52 | Patent 53 | Patent 54 | Patent 55 | Patent 56 | Patent 57 | Patent 58 | Patent 59 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| *****(******) | **** *** | *** ********* | *** ** ** | *** ********* | *** ********* | *** ** ** | *** ** ** | *** ** ** | ********* | ********* | ********* | ********* | *** ** ** | ********* | *** ********* | *** ********* | *** ********* | *** ** ** | ********* | ********* | *** ********* | *** ********* | *** ********* | ********* | *** ********* | *** ** ** / ******* ** ** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ** ** / ******* ** ** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ** ** / ******* ** ** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* |
| **** | **** *** | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ** *****'* | *** \ ** | ***** **, **** | *** ** ** & ** | ******** | '** ****' ******** ** **** **, **** |
| *****(******) | *** \ ** | ***** **, **** | *******/********* *** ** ** & ** | ******** | '** ****' ******** ** *** *, **** |
| **** | *** \ ** | ***** **, **** | ******* | ******** | ******** ** *** **, **** |
| Icosapent Ethyl | Amarin | ||
| 500 mg; capsule, Oral |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
None | ||
|
More Than 5
|
More Than 5
|
||
| Indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. | |||
|
Yes
| |||
| Vascepa | 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 | Patent 14 | Patent 15 | Patent 16 | Patent 17 | Patent 18 | Patent 19 | Patent 20 | Patent 21 | Patent 22 | Patent 23 | Patent 24 | Patent 25 | Patent 26 | Patent 27 | Patent 28 | Patent 29 | Patent 30 | Patent 31 | Patent 32 | Patent 33 | Patent 34 | Patent 35 | Patent 36 | Patent 37 | Patent 38 | Patent 39 | Patent 40 | Patent 41 | Patent 42 | Patent 43 | Patent 44 | Patent 45 | Patent 46 | Patent 47 | Patent 48 | Patent 49 | Patent 50 | Patent 51 | Patent 52 | Patent 53 | Patent 54 | Patent 55 | Patent 56 | Patent 57 | Patent 58 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| **** | **** *** | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* |
| *****(******) | *** ********* | *** ********* | *** ** ** | *** ********* | *** ********* | *** ** ** | *** ** ** | *** ** ** | ********* | *** ********* | ********* | **** ** **** **, **** | ********* | *** ********* | *** ********* | *** ********* | *** ** ** | ********* | ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ** ** / ******* ** ** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ** ** / ******* ** ** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ** ** / ******* ** ** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ** *****'* | *** \ ** | *** **,**** | *** ** ** & ** | ******** | *** ****** '**-****' |
| **** | ** \ ** | *** **,**** | ******* | ******** | ******** ** *** **** |
| *****(******) | ** \ ** | *** **, **** | *******/********* *** ** ** & ** | ******** | ******** '**-****' ** *** **, **** |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|