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Last Updated: March 19, 2024

Mipomersen sodium - Generic Drug Details


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What are the generic sources for mipomersen sodium and what is the scope of freedom to operate?

Mipomersen sodium is the generic ingredient in one branded drug marketed by Kastle Theraps Llc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Mipomersen sodium has forty-five patent family members in eleven countries.

Summary for mipomersen sodium
International Patents:45
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 9
Patent Applications: 857
What excipients (inactive ingredients) are in mipomersen sodium?mipomersen sodium excipients list
DailyMed Link:mipomersen sodium at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for mipomersen sodium
Generic Entry Date for mipomersen sodium*:
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.

Recent Clinical Trials for mipomersen sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kastle Therapeutics, LLCPhase 1
Ionis Pharmaceuticals, Inc.Phase 1
Ionis Pharmaceuticals, Inc.Phase 3

See all mipomersen sodium clinical trials

US Patents and Regulatory Information for mipomersen sodium

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 mipomersen sodium

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

EU/EMA Drug Approvals for mipomersen sodium

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

International Patents for mipomersen sodium

Country Patent Number Title Estimated Expiration
Japan 4986109 ⤷  Try a Trial
Japan 2005503142 ⤷  Try a Trial
Slovenia 2336318 ⤷  Try a Trial
Cyprus 1116385 ⤷  Try a Trial
Cyprus 1114199 ⤷  Try a Trial
European Patent Office 2336145 Modulation par anti-sense de l'expression de apolipoprotĂ©ine B (Antisense modulation of apolipoprotein B expression) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.