Details for New Drug Application (NDA): 203568
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The generic ingredient in KYNAMRO is mipomersen sodium. Additional details are available on the mipomersen sodium profile page.
Summary for 203568
Tradename: | KYNAMRO |
Applicant: | Kastle Theraps Llc |
Ingredient: | mipomersen sodium |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203568
Generic Entry Date for 203568*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 200MG/ML (200MG/ML) | ||||
Approval Date: | Jan 29, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 29, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 203568
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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