Mytesi is a drug owned by Napo Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 3 have expired. Mytesi's patents have been open to challenges since 31 December, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 31, 2031. Details of Mytesi'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). | |||
| US8962680 | Methods and compositions for treating HIV-associated diarrhea |
Oct, 2031
(6 years from now) | Active |
| US9585868 | Methods and compositions for treating HIV-associated diarrhea |
Oct, 2031
(6 years from now) | Active |
| US7341744 | Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer |
Jun, 2018
(6 years ago) |
Expired
|
| US7323195 | Enteric formulations of proanthocyanidin polymer antidiarrheal compositions |
Jun, 2018
(6 years ago) |
Expired
|
| US8574634 | Compositions and methods of treatment with proanthocyanidin polymer antidiarrheal compositions |
Jan, 2018
(7 years 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 Mytesi's patents.
Latest Legal Activities on Mytesi's Patents
Given below is the list of recent legal activities going on the following patents of Mytesi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 13 Dec, 2021 | US8574634 |
| Maintenance Fee Reminder Mailed Critical | 28 Jun, 2021 | US8574634 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 31 Aug, 2020 | US9585868 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Jul, 2020 | US9585868 |
| Email Notification Critical | 01 Jul, 2020 | US9585868 |
| Correspondence Address Change Critical | 29 Jun, 2020 | US8574634 |
| Correspondence Address Change Critical | 29 Jun, 2020 | US9585868 |
| Expire Patent Critical | 02 Mar, 2020 | US7323195 |
| Maintenance Fee Reminder Mailed Critical | 16 Sep, 2019 | US7323195 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Mar, 2017 | US9585868 |
FDA has granted several exclusivities to Mytesi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mytesi, 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 Mytesi.
Exclusivity Information
Mytesi holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Mytesi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 31, 2017 |
US patents provide insights into the exclusivity only within the United States, but Mytesi 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 Mytesi's family patents as well as insights into ongoing legal events on those patents.
Mytesi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mytesi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 31, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mytesi Generics:
There are no approved generic versions for Mytesi as of now.
About Mytesi
Mytesi is a drug owned by Napo Pharmaceuticals Inc. It is used for providing symptomatic relief for non-infectious diarrhea. Mytesi uses Crofelemer as an active ingredient. Mytesi was launched by Napo Pharms Inc in 2012.
Approval Date:
Mytesi was approved by FDA for market use on 31 December, 2012.
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 Mytesi is 31 December, 2012, its NCE-1 date is estimated to be 31 December, 2016.
Active Ingredient:
Mytesi uses Crofelemer as the active ingredient. Check out other Drugs and Companies using Crofelemer ingredient
Treatment:
Mytesi is used for providing symptomatic relief for non-infectious diarrhea.
Dosage:
Mytesi is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 125MG | TABLET, DELAYED RELEASE | Prescription | ORAL |