secnidazole · Evofem Inc · NDA 209363

Solosec

Earliest generic entry, as listed
11 Dec 2041

Blocked by patent: US 12280037. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 33 unexpired

PatentClaimsExpires
US 12280037use U-330211 Dec 2041
US 11684607product, use U-327016 Sep 2035
US 11684607product, use U-316916 Sep 2035
US 11684607product, use U-258316 Sep 2035
US 11684607product, use U-330216 Sep 2035
US 10335390product, use U-25834 Sep 2035
US 10335390product, use U-32704 Sep 2035
US 10682338product, use U-25834 Sep 2035
US 10682338product, use U-32704 Sep 2035
US 10849884product, use U-31694 Sep 2035
US 10849884product, use U-25834 Sep 2035
US 10849884product, use U-32704 Sep 2035
US 10849884product, use U-33024 Sep 2035
US 10857133product, use U-32704 Sep 2035
US 10857133product, use U-25834 Sep 2035
US 11000507product, use U-31694 Sep 2035
US 11000507product, use U-33024 Sep 2035
US 11000507product, use U-32704 Sep 2035
US 11000507product, use U-25834 Sep 2035
US 11000508product, use U-31694 Sep 2035
US 11000508product, use U-25834 Sep 2035
US 11000508product, use U-32704 Sep 2035
US 11000508product, use U-33024 Sep 2035
US 11020377product, use U-32704 Sep 2035
US 11020377product, use U-33024 Sep 2035
US 11020377product, use U-25834 Sep 2035
US 11020377product, use U-31694 Sep 2035
US 11324721product, use U-31694 Sep 2035
US 11324721product, use U-32704 Sep 2035
US 11324721product, use U-25834 Sep 2035
US 11324721product, use U-33024 Sep 2035
US 11602522product, use U-31694 Sep 2035
US 11602522product, use U-33024 Sep 2035

Exclusivities · 1 unexpired

GAINqualified infectious disease product15 Sep 2027

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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
209363 · 001 · RLDgranule, oral2GM/PACKET11 Dec 2041
Expired or delisted (1)
  • NCE · 15 Sep 2022