mipomersen Prefilled Syringe
- Brand(s)
- Kynamro
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Genzyme Corporation (2015-04-02)
- Oldest Current Product
- 2013-01-29
- License(s)
- NDA
- RxNORM
- PREFILLED SYRINGE\MIPOMERSEN
- FDAOB
- SUBCUTANEOUS\SOLUTION\MIPOMERSEN SODIUM
- SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\MIPOMERSEN SODIUM
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\MIPOMERSEN
product(s) by strength(s)
1 ml mipomersen sodium 200 mg/ml prefilled syringe
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 584680191 | Kynamro | NDA | Genzyme Corporation | 2013-01-29 | MIPOMERSEN SODIUM | SUBCUTANEOUS | INJECTION, SOLUTION | NDA203568 | 34de65be-f110-4000-a0f1-cb00ec98658f |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA203568 | KYNAMRO | GENZYME CORP | 2013-01-29 | p7511131 p7407943, ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY LIPOPROTEIN-CHOLESTEROL p7015315 p6166197 p7101993 p6222025 p6451991 | ORPHAN DRUG EXCLUSIVITY [2020-01-29] NEW CHEMICAL ENTITY [2018-01-29] | NDA203568_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA203568_001 | RX | MIPOMERSEN SODIUM (200MG/ML) | SUBCUTANEOUS | SOLUTION | True | 2013-01-29 | KYNAMRO |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6166197 (view patent) | 2017-12-26 | NDA203568 |
| 2 | p6222025 (view patent) | 2015-03-06 | NDA203568 |
| 3 | p6451991 (view patent) | 2017-02-11 | NDA203568 |
| 4 | p7015315 (view patent) | 2023-03-21 | NDA203568 |
| 5 | p7101993 (view patent) | 2023-09-05 | NDA203568 |
| 6 | p7407943 (view patent) | 2021-08-01 | NDA203568 |
| 7 | p7511131 (view patent) | 2025-12-13 | NDA203568 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 34de65be-f110-4000-a0f1-cb00ec98658f (view SPL) | These highlights do not include all the information needed to use KYNAMRO safely and effectively. See full prescribing information for KYNAMRO. KYNAMRO (mipomersen sodium) InjectionSolution for Subcutaneous InjectionInitial U.S. Approval: 2013 | prescription | Human Prescription | Genzyme Corporation | analysis, api manufacture, label, manufacture, pack | 2015-04-02 | 4 | 584680191 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII