Phexxi is a drug owned by Evofem Inc. It is protected by 5 US drug patents filed from 2021 to 2024. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 15, 2033. Details of Phexxi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11439610 | Compositions and methods for enhancing the efficacy of contraceptive microbicides |
Mar, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11337989 | Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound |
Mar, 2033
(8 years from now) | Active |
| US11992472 | Compositions and methods for enhancing the efficacy of contraceptive microbicides |
Mar, 2033
(8 years from now) | Active |
| US10568855 | Compositions and methods for enhancing the efficacy of contraceptive microbicides |
Mar, 2033
(8 years from now) | Active |
| US6706276 | Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa |
Mar, 2024
(7 months ago) |
Expired
|
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 Phexxi's patents.
Latest Legal Activities on Phexxi's Patents
Given below is the list of recent legal activities going on the following patents of Phexxi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Interim Patent Term Extension Granted Critical | 30 Jan, 2024 | US6706276 |
| Email Notification Critical | 08 Sep, 2023 | US11337989 |
| Change in Power of Attorney (May Include Associate POA) Critical | 08 Sep, 2023 | US11337989 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 09 Aug, 2023 | US10568855 |
| Interim Patent Term Extension Granted Critical | 04 Aug, 2023 | US6706276 |
| Email Notification Critical | 28 Feb, 2023 | US6706276 |
| Interim Patent Term Extension Granted Critical | 22 Feb, 2023 | US6706276 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Feb, 2023 | US6706276 |
| Correspondence Address Change Critical | 09 Feb, 2023 | US6706276 |
| Change in Power of Attorney (May Include Associate POA) Critical | 31 Jan, 2023 | US10568855 |
FDA has granted several exclusivities to Phexxi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Phexxi, 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 Phexxi.
Exclusivity Information
Phexxi holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Phexxi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 22, 2023 |
US patents provide insights into the exclusivity only within the United States, but Phexxi 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 Phexxi's family patents as well as insights into ongoing legal events on those patents.
Phexxi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Phexxi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Phexxi Generics:
There are no approved generic versions for Phexxi as of now.
How can I launch a generic of Phexxi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Phexxi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Phexxi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Phexxi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.8%/1%/0.4% | 28 Feb, 2023 | 1 | 15 Mar, 2033 |
Alternative Brands for Phexxi
Phexxi which is used for contraception., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil |
| |||||||||||
| Bayer Hlthcare |
| |||||||||||
| Organon |
| |||||||||||
| Teva Branded Pharm |
| |||||||||||
| Wyeth Pharms Inc |
| |||||||||||
About Phexxi
Phexxi is a drug owned by Evofem Inc. It is used for contraception. Phexxi uses Citric Acid; Lactic Acid; Potassium Bitartrate as an active ingredient. Phexxi was launched by Evofem Inc in 2020.
Can you believe Phexxi received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Phexxi was approved by FDA for market use on 22 May, 2020.
Active Ingredient:
Phexxi uses Citric Acid; Lactic Acid; Potassium Bitartrate as the active ingredient. Check out other Drugs and Companies using Citric Acid; Lactic Acid; Potassium Bitartrate ingredient
Treatment:
Phexxi is used for contraception.
Dosage:
Phexxi is available in gel form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1%;1.8%;0.4% | GEL | Prescription | VAGINAL |