octreotide acetate · Novartis · NDA 021008
Sandostatin Lar
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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
- Generic approved · ANDA 216589, Mylan Labs Ltd · 021008-001Approved 12 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021008 · 001 · RLD | injectable, injection | EQ 10MG BASE/VIAL | open |
| 021008 · 002 · RLD | injectable, injection | EQ 20MG BASE/VIAL | open |
| 021008 · 003 · RLD | injectable, injection | EQ 30MG BASE/VIAL | open |