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 |
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 |
International Patents for KYNAMRO
See the table below for patents covering KYNAMRO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 4848793 | ⤷ Sign Up | |
Australia | 2003251387 | ⤷ Sign Up | |
Australia | 715760 | ⤷ Sign Up | |
Germany | 69433626 | ⤷ Sign Up | |
Australia | 3892395 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |