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SOLOSEC

NDA

SECNIDAZOLE | N209363 | EVOFEM INC

1 strength11 unique patents2 unique exclusivities

Patent Timeline

11 unique patents, 2 exclusivities by expiration date

Active (11)TodayExclusivity

2022

2023

2024

2025

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2027

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Today

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 4, 2035

Sep. 16, 2035

Dec. 11, 2041

NCE

Sep. 15, 2022

GAIN

Sep. 15, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis NCT02147899	Phase 2	Completed	Symbiomix Therapeutics	215	2014-05 → 2014-10
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis NCT03935217	Phase 3	Completed	Lupin Research Inc	147	2019-04-23 → 2020-03-25
Studies of Immune Responses to Orally Administered Vaccines in Developing Country NCT01019083	Phase 1/2	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	1,016	2008-02 → 2010-12
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 NCT02452866	Phase 3	Completed	Symbiomix Therapeutics	325	2015-06 → 2015-10
Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge NCT02111629	Phase 3	Completed	Universidad Nacional de Colombia	118	2012-05 → 2013-05
Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV NCT03937869	Phase 4	Completed	Lupin Research Inc	40	2018-11-28 → 2020-11-05
A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults NCT01733966	Phase 3	Terminated	Quanta Medical	100	2010-05 → 2012-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$282.52

per ea

Lowest NADAC/Unit

$282.52

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69751040001SOLOSEC 2 GM GRANULE PACKET	$282.52	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$172.08

Highest Price

$172.08

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69751-0400-01SOLOSEC 2GM/PKT GRANULES	$172.08	FSS	Evofem Biosciences, Inc.	05/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Solosec (2024)

Total Spending

$56K

Total Claims

190

Beneficiaries

157

Avg Cost/Unit

$280.72

Spending Trend

$143K(2019)→$121K(2020)→$87K(2021)→$83K(2022)→$70K(2023)→$56K(2024)

YoY Change:-5.7%

5yr CAGR:-0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDSECNIDAZOLE

DMF 194502006

CORDEN PHARMA BERGAMO SPASECNIDAZOLE

DMF 273832013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 27, 2022	SUPPL -14	View Letter (PDF)
Jan 27, 2022	SUPPL -16	View Letter (PDF)
Dec 21, 2021	SUPPL -17	View Letter (PDF)
Jul 1, 2021	SUPPL -12	View Letter (PDF)
Jun 15, 2021	SUPPL -15	View Letter (PDF)
Sep 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2GM/PACKET

RLD

11 patents2 exclusivities▴

GRANULE;ORAL | Approved: Sep 15, 2017

Patents (11) · 33 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10335390	Sep 4, 2035	—	—	Yes	—
10682338	Sep 4, 2035	—	—	Yes	—
10849884	Sep 4, 2035	—	—	Yes	—
10857133	Sep 4, 2035	—	—	Yes	—
11000507	Sep 4, 2035	—	—	Yes	—
11000508	Sep 4, 2035	—	—	Yes	—
11020377	Sep 4, 2035	—	—	Yes	—
11324721	Sep 4, 2035	—	—	Yes	—
11602522	Sep 4, 2035	—	—	Yes	—
11684607	Sep 16, 2035	—	—	Yes	—
12280037	Dec 11, 2041	—	—	—	—

Exclusivities (2)

Code	Date	Status
GAIN	Sep 15, 2027	Active
NCE	Sep 15, 2022	Expired