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Last Updated: October 18, 2021

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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 are four patents protecting this drug. Additional details are available on the KYNAMRO profile page.

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:4
DrugPatentWatch® Estimated Generic Entry Opportunity 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:DISCNDosage:SOLUTION;SUBCUTANEOUSStrength200MG/ML (200MG/ML)
Approval Date:Jan 29, 2013TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Mar 21, 2023Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Sep 5, 2023Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Aug 1, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY LIPOPROTEIN-CHOLESTEROL, APOLIPOPROTEIN B, TOTAL CHOLESTEROL, AND NON-HIGH DENSITY LIPOPROTEIN CHOLESTEROL IN PTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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