Solosec Generic: When Will Generic Secnidazole Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Solosec Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2027 About 12 months away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? December 2041 11 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic secnidazole is expected to be available in September 2027, about 12 months away. None is for sale yet.
Why September 2027?
It is when Solosec’s FDA protection for antibiotic incentive (gain) ends. Five more years for a medicine that treats a serious or life-threatening infection. We rate it probable: more likely than not, but it can still move.
If Solosec’s last patent runs to December 2041, how can a generic come sooner?
The 11 patents that run past the expected month, to December 2041 (10,335,390, 10,682,338, 10,849,884, 10,857,133 and 7 more), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Solosec as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Solosec by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $2M a yearSmaller seller
- FDA approved 2017 September 2017 FDA Orange Book
- Patents listed 11 last runs to December 2041 A generic is expected sooner, in September 2027. See why FDA Orange Book
- Pharmacies pay $281.96 each, up 4.1% in a year NADAC, October 2026
- Medicare Part D spent $57.3K in 2025, for 138 people CMS Part D Spending by Drug
- Medicaid prescriptions 565 in the last four reported quarters, $172.2K CMS Medicaid drug utilization, to Q1 2026
Solosec’s Road to a Generic
Solosec has had the market to itself since the FDA approved it in September 2017 (Evofem Inc). Its FDA protection (antibiotic incentive (gain)) runs to September 2027. Its 11 listed patents run to December 2041.
The first generic of Solosec is expected in September 2027.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then. That is about 14 years before the last listed patent runs out, in December 2041.
Why a Generic Can Come Before December 2041
The last listed patent runs to December 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Solosec Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Solosec’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,335,390 | The product’s formulation; a way of using it (U-2583, U-3270) | September 2035 | Active |
| 10,682,338 | The product’s formulation; a way of using it (U-3270, U-2583) | September 2035 | Active |
| 10,849,884 | The product’s formulation; a way of using it (U-3270, U-3302, U-3169, U-2583) | September 2035 | Active |
| 10,857,133 | The product’s formulation; a way of using it (U-3270, U-2583) | September 2035 | Active |
| 11,000,507 | The product’s formulation; a way of using it (U-3302, U-3270, U-3169, U-2583) | September 2035 | Active |
| 11,000,508 | The product’s formulation; a way of using it (U-3302, U-3270, U-3169, U-2583) | September 2035 | Active |
| 11,020,377 | The product’s formulation; a way of using it (U-3302, U-3270, U-3169, U-2583) | September 2035 | Active |
| 11,324,721 | The product’s formulation; a way of using it (U-2583, U-3169, U-3270, U-3302) | September 2035 | Active |
| 11,602,522 | The product’s formulation; a way of using it (U-3169, U-3302) | September 2035 | Active |
| 11,684,607 | The product’s formulation; a way of using it (U-2583, U-3169, U-3270, U-3302) | September 2035 | Active |
| 12,280,037 | A way of using it (U-3302) | December 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | September 2022 | Ended |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | September 2027 | Active |
Source: FDA Orange Book, application 209363. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Secnidazole
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Solosec yet.
Approved by the FDA
Not yet. The FDA has not approved a generic secnidazole. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic secnidazole for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Solosec Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Solosec 2 gm granule packet
$281.96 each in October 2026, up 4.1% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $281.96 |
| September 2026 | $281.96 |
| August 2026 | $281.55 |
| July 2026 | $281.09 |
| June 2026 | $282.53 |
| May 2026 | $282.56 |
| April 2026 | $283.15 |
| March 2026 | $283.15 |
| February 2026 | $283.15 |
| January 2026 | $283.15 |
| February 2024 | $270.76 |
| January 2024 | $270.76 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Solosec today: $281.96 each for Solosec 2 gm granule packet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Dollar figures apply FDA’s median drops to the $281.96 pharmacies pay each today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Solosec
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Solosec, before manufacturer rebates.
- $15K
- January to March 2026, the latest CMS has posted
For 38 people, about $289 per prescription fill - $57.3K
- 2025, the whole year
For 138 people, about $309 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $15,010 | 38 | $288.65 |
| 2025 | $57,256 | 138 | $309.49 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Solosec only, so no generic is counted in it. What CMS says it is used for: Secnidazole is used to treat a certain type of vaginal infection (bacterial vaginosis) in women. It is also used to treat a certain common sexually transmitted infection (trichomoniasis).
Medicaid Prescriptions by Quarter
565 prescriptions in the four quarters to Q1 2026, $172.2K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 193 | $62,452 |
| Q4 2025 | 178 | $53,822 |
| Q3 2025 | 194 | $55,950 |
| Q2 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Solosec’s own package codes.
Solosec Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 2GM/PACKET | Granule | Oral | September 2017 | Prescription reference product |
Source: FDA Orange Book, Evofem Inc. Listed for sale today by Lupin Pharmaceuticals, Inc. and Evofem Inc. (FDA NDC Directory).
Solosec NDC Codes and Packages
Each Solosec package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 27437-0051-01 | 2 g/4.8g granule | packet of 2 g | Lupin Pharmaceuticals, Inc. |
| 27437-0051-02 | 2 g/4.8g granule | packet of 2 g | Lupin Pharmaceuticals, Inc. |
| 69751-0400-01 | SECNIDAZOLE 2 g/4.8g granule | packet of 2 g | Evofem Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Solosec’s own FDA approval (NDA 209363) are listed, never a generic. Some codes belong to companies that repackage Solosec: it is the same medicine in a different package.
What a Generic Solosec Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Solosec as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Solosec”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Solosec
Is there a generic for Solosec right now?
No. As of October 9, 2026 no generic secnidazole is listed for sale in the FDA NDC Directory.
When will Solosec go generic?
September 2027 is the expected month, and that is probable but not certain. It is when Solosec’s FDA protection for antibiotic incentive (gain) ends. Five more years for a medicine that treats a serious or life-threatening infection. The last listed patent runs to December 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic secnidazole be the same as Solosec?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Solosec?
Not yet. The FDA Orange Book lists no approved generic version of Solosec.
When does the Solosec patent expire?
The FDA Orange Book lists 11 patents for Solosec; the last runs to December 2041. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (September 2027) weighs all of that.
How much does Solosec cost now?
Pharmacies paid about $281.96 each for Solosec 2 gm granule packet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected September 2027 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- GloperbaColchicine2027 to 2028
- MacrilenMacimorelin AcetateApril 2028
- TruqapCapivasertibMarch 2035
- QlosiPilocarpine HydrochlorideAugust 2037
- ZimhiNaloxone HydrochlorideMay 2039
- ChloraPrepChlorhexidine Gluconate and Isopropyl AlcoholTBD no date yet
About Solosec
- Generic name secnidazole
- How it is taken By mouth
- Company Evofem Inc
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Solosec
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.