Exem Foam Kit is a drug owned by Giskit Pharma Bv. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Exem Foam Kit's patents have been open to challenges since 08 November, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 11, 2036. Details of Exem Foam Kit'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). | |||
| US9849199 | Composition and method for medical imaging of body cavities |
Feb, 2036
(11 years from now) | Active |
| US9259494 | Composition and method for medical imaging of body cavities |
May, 2035
(10 years from now) | Active |
| US9034300 | Composition and method for medical imaging of body cavities |
Oct, 2030
(5 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 Exem Foam Kit's patents.
Latest Legal Activities on Exem Foam Kit's Patents
Given below is the list of recent legal activities going on the following patents of Exem Foam Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Nov, 2022 | US9034300 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Jun, 2021 | US9849199 |
| Initial letter Re: PTE Application to regulating agency | 06 Nov, 2020 | US9034300 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Nov, 2018 | US9034300 |
| Recordation of Patent Grant Mailed Critical | 26 Dec, 2017 | US9849199 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Dec, 2017 | US9849199 |
| Email Notification Critical | 07 Dec, 2017 | US9849199 |
| Issue Notification Mailed Critical | 06 Dec, 2017 | US9849199 |
| Dispatch to FDC | 17 Nov, 2017 | US9849199 |
| Application Is Considered Ready for Issue Critical | 17 Nov, 2017 | US9849199 |
FDA has granted several exclusivities to Exem Foam Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exem Foam Kit, 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 Exem Foam Kit.
Exclusivity Information
Exem Foam Kit holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Exem Foam Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 07, 2024 |
US patents provide insights into the exclusivity only within the United States, but Exem Foam Kit 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 Exem Foam Kit's family patents as well as insights into ongoing legal events on those patents.
Exem Foam Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exem Foam Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 11, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exem Foam Kit Generics:
There are no approved generic versions for Exem Foam Kit as of now.
About Exem Foam Kit
Exem Foam Kit is a drug owned by Giskit Pharma Bv. It is used for assessing fallopian tube patency in sonohysterosalpingography. Exem Foam Kit uses Air Polymer-Type A as an active ingredient. Exem Foam Kit was launched by Giskit in 2019.
Approval Date:
Exem Foam Kit was approved by FDA for market use on 07 November, 2019.
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 Exem Foam Kit is 07 November, 2019, its NCE-1 date is estimated to be 08 November, 2023.
Active Ingredient:
Exem Foam Kit uses Air Polymer-type A as the active ingredient. Check out other Drugs and Companies using Air Polymer-type A ingredient
Treatment:
Exem Foam Kit is used for assessing fallopian tube patency in sonohysterosalpingography.
Dosage:
Exem Foam Kit is available in foam form for intrauterine use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10ML | FOAM | Prescription | INTRAUTERINE |