Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Cipla
Healthtrust
Baxter
UBS
Fish and Richardson

Generated: August 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203568

  Try a free trial


See Plans and Pricing

« 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 one supplier. There are four patents protecting this drug. Additional details are available on the KYNAMRO profile page.

The generic ingredient in KYNAMRO is mipomersen sodium. One supplier is 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
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.

Pharmacology for NDA: 203568
Physiological EffectDecreased Protein Synthesis
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 Kastle Therapeutics, LLC 70688-0502 70688-0502-1 1 SYRINGE in 1 CARTON (70688-0502-1) > 1 mL in 1 SYRINGE
KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568 NDA Kastle Therapeutics, LLC 70688-0502 70688-0502-2 4 SYRINGE in 1 CARTON (70688-0502-2) > 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage: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)
Patent:  Try a Free TrialPatent Expiration:Mar 21, 2023Product Flag?Substance Flag?YDelist Request?
Patent:  Try a Free TrialPatent Expiration:Sep 5, 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

Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Cantor Fitzgerald
Chubb
Daiichi Sankyo
Healthtrust
Accenture

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.