Details for New Drug Application (NDA): 203568
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NDA 203568 describes KYNAMRO, which is a drug marketed by Kastle Theraps Llc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the KYNAMRO profile page.
The generic ingredient in KYNAMRO is mipomersen sodium. There is one drug master file entry for this compound. Additional details are available on the mipomersen sodium profile page.
The generic ingredient in KYNAMRO is mipomersen sodium. There is one drug master file entry for this compound. 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: | ⤷ Start Trial | 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 | ⤷ Start Trial | ⤷ Start Trial |
| Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Kastle Theraps Llc | KYNAMRO | mipomersen sodium | SOLUTION;SUBCUTANEOUS | 203568-001 | Jan 29, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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