mipomersen sodium · Kastle Theraps Llc · NDA 203568
Kynamro
Earliest generic entry, as listed
29 Jan 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7511131.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7511131 | drug substance · sets the listed date | 29 Jan 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Enters 12-month window basis: patent · 203568-001Listed date 29 Jan 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203568 · 001 · RLD · discontinued | solution, subcutaneous | 200MG/ML (200MG/ML) | 29 Jan 2027 |