Phexx 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 Phexx'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
(6 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
(6 years from now) | Active |
| US11992472 | Compositions and methods for enhancing the efficacy of contraceptive microbicides |
Mar, 2033
(6 years from now) | Active |
| US10568855 | Compositions and methods for enhancing the efficacy of contraceptive microbicides |
Mar, 2033
(6 years from now) | Active |
| US6706276 | Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa |
Mar, 2024
(2 years ago) |
Expired
|
FDA has granted several exclusivities to Phexx. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Phexx, 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
Phexx.
Exclusivity Information
Phexx holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Phexx'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
Phexx 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 Phexx's family patents as well as insights into
ongoing legal events
on those patents.
Phexx's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Phexx'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)
Phexx Generics:
There are no approved generic versions for Phexx as of now.
How can I launch a generic of Phexx before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Phexx's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Phexx'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 Phexx -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 Feb, 2023 | 15 Mar, 2033 | Extinguished | Less |
Alternative Brands for Phexx
There are several other brand drugs in the same treatment category as Phexx. 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 Phexx
Phexx is a drug owned by Evofem Inc. Phexx uses Citric Acid; Lactic Acid; Potassium Bitartrate as an active ingredient. Phexx was launched by Evofem in 2020.
Approval Date:
Phexx was approved by FDA for market use on 22 May, 2020.
Active Ingredient:
Phexx 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
Dosage:
Phexx 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 |