Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Dow
Daiichi Sankyo
Teva
Fish and Richardson
QuintilesIMS
Baxter
Argus Health

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203568

« Back to Dashboard

NDA 203568 describes KYNAMRO, which is a drug marketed by Kastle Theraps Llc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the KYNAMRO profile page.

The generic ingredient in KYNAMRO is mipomersen sodium. Two suppliers are listed 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:4
Pharmacology for NDA: 203568
Suppliers and Packaging for NDA: 203568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568 NDA Genzyme Corporation 58468-0191 N 58468-0191-2
KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568 NDA Genzyme Corporation 58468-0191 N 58468-0191-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength200MG/ML (200MG/ML)
Approval Date:Jan 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 29, 2020
Regulatory Exclusivity Use:ADJUNCT TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LDL-C, APOLIPOPROTEIN B (APO B), TOTAL CHOLESTEROL (TC), AND NON-HIGH DENSITY LIPOPROTEIN-CHOLESTEROL (NON-HDL-C) IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
Regulatory Exclusivity Expiration:Jan 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Mar 21, 2023Product Flag?Substance Flag?YDelist 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 ➤ Try a Free Trial ➤ Try a Free Trial
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
US Army
Merck
Chinese Patent Office
Cerilliant
Chubb
Julphar
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.