Solosec is a drug owned by Evofem Inc. It is protected by 10 US drug patents filed from 2019 to 2023 out of which none have expired yet. Solosec's patents will be open to challenges from 15 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 16, 2035. Details of Solosec's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11684607 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US10857133 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US10682338 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US11000508 | Secnidazole for use in the treatment of trichomoniasis |
Sep, 2035
(10 years from now) | Active |
| US11000507 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US11020377 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US10335390 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US11602522 | Secnidazole for use in the treatment of sexually transmitted infection |
Sep, 2035
(10 years from now) | Active |
| US10849884 | Secnidazole for use in the treatment of bacterial vaginosis |
Sep, 2035
(10 years from now) | Active |
| US11324721 | Secnidazole for use in the treatment of trichomoniasis |
Sep, 2035
(10 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Solosec's patents.
Latest Legal Activities on Solosec's Patents
Given below is the list of recent legal activities going on the following patents of Solosec.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jul, 2024 | US11000507 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jul, 2024 | US11000508 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Dec, 2023 | US10849884 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Dec, 2023 | US10857133 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jun, 2023 | US10682338 |
| Electronic Review Critical | 27 Jun, 2023 | US11684607 |
| Email Notification Critical | 27 Jun, 2023 | US11684607 |
| Mail Patent eGrant Notification | 27 Jun, 2023 | US11684607 |
| Patent eGrant Notification | 27 Jun, 2023 | US11684607 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Jun, 2023 | US11684607 |
FDA has granted several exclusivities to Solosec. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Solosec, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Solosec.
Exclusivity Information
Solosec holds 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Solosec's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 15, 2022 |
| New Indication(I-866) | Jun 30, 2024 |
| New Patient Population(NPP) | Jan 26, 2025 |
| Generating Antibiotic Incentives Now(GAIN) | Sep 15, 2027 |
US patents provide insights into the exclusivity only within the United States, but Solosec is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Solosec's family patents as well as insights into ongoing legal events on those patents.
Solosec's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Solosec's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Solosec Generics:
There are no approved generic versions for Solosec as of now.
About Solosec
Solosec is a drug owned by Evofem Inc. It is used for treating bacterial vaginosis and trichomoniasis in women and female patients 12 years of age and older. Solosec uses Secnidazole as an active ingredient. Solosec was launched by Evofem Inc in 2017.
Approval Date:
Solosec was approved by FDA for market use on 15 September, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Solosec is 15 September, 2017, its NCE-1 date is estimated to be 15 September, 2026.
Active Ingredient:
Solosec uses Secnidazole as the active ingredient. Check out other Drugs and Companies using Secnidazole ingredient
Treatment:
Solosec is used for treating bacterial vaginosis and trichomoniasis in women and female patients 12 years of age and older.
Dosage:
Solosec is available in granule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2GM/PACKET | GRANULE | Prescription | ORAL |