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Last Updated: November 23, 2024

KYNAMRO Drug Patent Profile


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Which patents cover Kynamro, and what generic alternatives are available?

Kynamro is a drug marketed by Kastle Theraps Llc and is included in one NDA. There is one patent protecting this drug.

This drug has forty-five patent family members in eleven countries.

The generic ingredient in KYNAMRO is mipomersen sodium. Additional details are available on the mipomersen sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Kynamro

Kynamro was eligible for patent challenges on January 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 29, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for KYNAMRO
International Patents:45
US Patents:1
Applicants:1
NDAs:1
Drug Prices: Drug price information for KYNAMRO
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for KYNAMRO
What excipients (inactive ingredients) are in KYNAMRO?KYNAMRO excipients list
DailyMed Link:KYNAMRO at DailyMed
Drug patent expirations by year for KYNAMRO
Drug Prices for KYNAMRO

See drug prices for KYNAMRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KYNAMRO
Generic Entry Date for KYNAMRO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for KYNAMRO

KYNAMRO is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KYNAMRO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KYNAMRO

Antisense modulation of apolipoprotein B expression
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kastle Theraps Llc KYNAMRO mipomersen sodium SOLUTION;SUBCUTANEOUS 203568-001 Jan 29, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for KYNAMRO

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
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

EU/EMA Drug Approvals for KYNAMRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Genzyme Europe BV Kynamro mipomersen sodium EMEA/H/C/002429
treatment of cholesterol and hypercholesterolaemia
Refused no no no 2013-05-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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