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 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for mipomersen sodium |
| 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
*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
| Sponsor | Phase |
|---|---|
| Ionis Pharmaceuticals, Inc. | Phase 1 |
| Kastle Therapeutics, LLC | Phase 1 |
| Kastle Therapeutics, LLC | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for mipomersen sodium
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 | ⤷ 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 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 | ⤷ 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 |
| 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 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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 03097662 | ⤷ Sign Up | |
| European Patent Office | 2336319 | Modulation anti-sens d'expression B apolipoprotéine (Antisense modulation of apolipoprotein B expression) | ⤷ Sign Up |
| Japan | 2005503142 | ⤷ Sign Up | |
| Japan | 2015198669 | アポリポタンパク質Ｂ発現のアンチセンス調節 (ANTISENSE MODULATION OF APOLIPOPROTEIN B EXPRESSION) | ⤷ Sign Up |
| Japan | 5342493 | ⤷ Sign Up | |
| Canada | 2505801 | MODULATION ANTISENS DE L'EXPRESSION D'APOLIPOPROTEINE B (ANTISENSE MODULATION OF APOLIPOPROTEIN B EXPRESSION) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
