Phexxi Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Phexxi.

Activity Date Patent Number
Patent litigations
Interim Patent Term Extension Granted 30 Jan, 2024 US6706276
Email Notification 08 Sep, 2023 US11337989
Change in Power of Attorney (May Include Associate POA) 08 Sep, 2023 US11337989
Payment of Maintenance Fee, 4th Yr, Small Entity 09 Aug, 2023 US10568855
Interim Patent Term Extension Granted 04 Aug, 2023 US6706276
Email Notification 28 Feb, 2023 US6706276
Interim Patent Term Extension Granted 22 Feb, 2023 US6706276
Change in Power of Attorney (May Include Associate POA) 10 Feb, 2023 US6706276
Correspondence Address Change 09 Feb, 2023 US6706276
Change in Power of Attorney (May Include Associate POA) 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

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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

Phexxi has patent protection in a total of 23 countries. It's US patent count contributes only to 25.4% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Phexxi.

Family Patents

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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
Taytulla Used for contraception.
Femcon Fe Used for contraception.
Lo Minastrin Fe Used for preventing pregnancy.
Minastrin 24 Fe Used for contraception.
Bayer Hlthcare
Yaz Used for contraception, prevention of pregnancy, and treating premenstrual dysphoric disorder in premenopausal females.
Beyaz Used for contraception, prevention of pregnancy, and treating mood changes and anxiety in women with PMDD who choose oral contraceptives.
Yasmin Used for contraception.
Natazia Used for preventing pregnancy and treating heavy menstrual bleeding in women who use oral contraceptives.
Safyral Used for preventing pregnancy and raising folate levels to reduce the risk of neural tube defects in pregnancy.
Organon
Implanon Used for contraception.
Nexplanon Used for contraception.
Teva Branded Pharm
Quartette Used for contraception.
Seasonale Used for contraception in women.
Seasonique Used for preventing pregnancy in women using oral contraceptives.
Loseasonique Used for contraceptive purposes.
Loestrin 24 Fe Used for preventing pregnancy.
Wyeth Pharms Inc
Lybrel Used for contraception.





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