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 · 11 unexpired

33 Orange Book listing rows for 11 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 12280037	use U-3302 · sets the listed date	11 Dec 2041	listed 19 May 2025
US 11684607	drug product, use U-2583, U-3169, U-3270, U-3302	16 Sep 2035	4 listing rows
US 11684607 listing row	drug product, use U-2583	16 Sep 2035	listed 7 Jul 2023
US 11684607 listing row	drug product, use U-3169	16 Sep 2035	listed 7 Jul 2023
US 11684607 listing row	drug product, use U-3270	16 Sep 2035	listed 7 Jul 2023
US 11684607 listing row	drug product, use U-3302	16 Sep 2035	listed 7 Jul 2023
US 10335390	drug product, use U-2583, U-3270	4 Sep 2035	2 listing rows
US 10335390 listing row	drug product, use U-2583	4 Sep 2035	listed 31 Jul 2019
US 10335390 listing row	drug product, use U-3270	4 Sep 2035	listed 31 Jul 2019
US 10682338	drug product, use U-2583, U-3270	4 Sep 2035	2 listing rows
US 10682338 listing row	drug product, use U-2583	4 Sep 2035	listed 23 Jun 2020
US 10682338 listing row	drug product, use U-3270	4 Sep 2035	listed 23 Jun 2020
US 10849884	drug product, use U-2583, U-3169, U-3270, U-3302	4 Sep 2035	4 listing rows
US 10849884 listing row	drug product, use U-2583	4 Sep 2035	listed 11 Dec 2020
US 10849884 listing row	drug product, use U-3169	4 Sep 2035	listed 11 Dec 2020
US 10849884 listing row	drug product, use U-3270	4 Sep 2035	listed 11 Dec 2020
US 10849884 listing row	drug product, use U-3302	4 Sep 2035	listed 11 Dec 2020
US 10857133	drug product, use U-2583, U-3270	4 Sep 2035	2 listing rows
US 10857133 listing row	drug product, use U-2583	4 Sep 2035	listed 11 Dec 2020
US 10857133 listing row	drug product, use U-3270	4 Sep 2035	listed 11 Dec 2020
US 11000507	drug product, use U-2583, U-3169, U-3270, U-3302	4 Sep 2035	4 listing rows
US 11000507 listing row	drug product, use U-2583	4 Sep 2035	listed 7 Jun 2021
US 11000507 listing row	drug product, use U-3169	4 Sep 2035	listed 7 Jun 2021
US 11000507 listing row	drug product, use U-3270	4 Sep 2035	listed 7 Jun 2021
US 11000507 listing row	drug product, use U-3302	4 Sep 2035	listed 7 Jun 2021
US 11000508	drug product, use U-2583, U-3169, U-3270, U-3302	4 Sep 2035	4 listing rows
US 11000508 listing row	drug product, use U-2583	4 Sep 2035	listed 7 Jun 2021
US 11000508 listing row	drug product, use U-3169	4 Sep 2035	listed 7 Jun 2021
US 11000508 listing row	drug product, use U-3270	4 Sep 2035	listed 7 Jun 2021
US 11000508 listing row	drug product, use U-3302	4 Sep 2035	listed 7 Jun 2021
US 11020377	drug product, use U-2583, U-3169, U-3270, U-3302	4 Sep 2035	4 listing rows
US 11020377 listing row	drug product, use U-2583	4 Sep 2035	listed 16 Jun 2021
US 11020377 listing row	drug product, use U-3169	4 Sep 2035	listed 16 Jun 2021
US 11020377 listing row	drug product, use U-3270	4 Sep 2035	listed 16 Jun 2021
US 11020377 listing row	drug product, use U-3302	4 Sep 2035	listed 16 Jun 2021
US 11324721	drug product, use U-2583, U-3169, U-3270, U-3302	4 Sep 2035	4 listing rows
US 11324721 listing row	drug product, use U-2583	4 Sep 2035	listed 18 May 2022
US 11324721 listing row	drug product, use U-3169	4 Sep 2035	listed 18 May 2022
US 11324721 listing row	drug product, use U-3270	4 Sep 2035	listed 18 May 2022
US 11324721 listing row	drug product, use U-3302	4 Sep 2035	listed 18 May 2022
US 11602522	drug product, use U-3169, U-3302	4 Sep 2035	2 listing rows
US 11602522 listing row	drug product, use U-3169	4 Sep 2035	listed 27 Mar 2023
US 11602522 listing row	drug product, use U-3302	4 Sep 2035	listed 27 Mar 2023

Exclusivities · 1 unexpired

GAIN

qualified infectious disease product

15 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 · product	Form	Strength	Approved	Listed expiry
209363 · 001 · RLD	granule, oral	2GM/PACKET	15 Sep 2017	11 Dec 2041

Expired or delisted (1)

NCE · 15 Sep 2022