malathion · Taro · NDA 018613

Ovide

Earliest generic entry, as listed
1 Feb 2027

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 7560445.

Listed patents · 1 unexpired

PatentClaimsExpires
US 7560445substance, product, use U-9861 Feb 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

  • 24 Oct 2026Enters 12-month window basis: patent · 018613-001

Products covered · 1

NDA · productFormStrengthListed expiry
018613 · 001 · RLD · discontinuedlotion, topical0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**1 Feb 2027
Expired or delisted (1)
  • US 7977324 · product · 14 Aug 2026