Xermelo is a drug owned by Tersera Therapeutics Llc. It is protected by 5 US drug patents filed in 2017 out of which none have expired yet. Xermelo's patents have been open to challenges since 28 February, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 28, 2031. Details of Xermelo'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. | |||
| US7709493 | 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use |
Feb, 2031
(5 years from now) | Active |
| US8193204 | Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1- (4-chloro-2-(3-methyl-1H-pyrazol-1-YL)phenyl)2,2,2-trifluoroethoxy)-pyrimidin-4-YL)phenyl)propanoate and methods of their use |
Feb, 2031
(5 years from now) | Active |
| US7553840 | 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use |
Dec, 2027
(2 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). | |||
| US8653094 | Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)-pyrimidin-4-yl)phenyl)propanoate and methods of their use |
Dec, 2028
(3 years from now) | Active |
| US7968559 | Methods of using 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds |
Dec, 2027
(2 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 Xermelo's patents.
Latest Legal Activities on Xermelo's Patents
Given below is the list of recent legal activities going on the following patents of Xermelo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Nov, 2023 | US8193204 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Dec, 2022 | US7968559 |
| Mail Pub Notice re 312 amendment | 01 Mar, 2022 | US7709493 |
| Email Notification Critical | 01 Mar, 2022 | US7709493 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 25 Feb, 2022 | US7709493 |
| Post Issue Communication - Certificate of Correction Denied | 25 Feb, 2022 | US7709493 |
| Patent Term Extension Certificate Critical | 06 Dec, 2021 | US7709493 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Oct, 2021 | US8193204 |
| Email Notification Critical | 27 Oct, 2021 | US8193204 |
| Correspondence Address Change Critical | 25 Oct, 2021 | US8193204 |
FDA has granted several exclusivities to Xermelo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xermelo, 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 Xermelo.
Exclusivity Information
Xermelo holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Xermelo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 28, 2022 |
| Orphan Drug Exclusivity(ODE) | Feb 28, 2024 |
| Orphan Drug Exclusivity(ODE-132) | Feb 28, 2024 |
US patents provide insights into the exclusivity only within the United States, but Xermelo 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 Xermelo's family patents as well as insights into ongoing legal events on those patents.
Xermelo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xermelo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 28, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xermelo Generics:
There are no approved generic versions for Xermelo as of now.
About Xermelo
Xermelo is a drug owned by Tersera Therapeutics Llc. It is used for treating carcinoid syndrome diarrhea in adults inadequately controlled by somatostatin analog therapy. Xermelo uses Telotristat Etiprate as an active ingredient. Xermelo was launched by Tersera in 2017.
Approval Date:
Xermelo was approved by FDA for market use on 28 February, 2017.
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 Xermelo is 28 February, 2017, its NCE-1 date is estimated to be 28 February, 2021.
Active Ingredient:
Xermelo uses Telotristat Etiprate as the active ingredient. Check out other Drugs and Companies using Telotristat Etiprate ingredient
Treatment:
Xermelo is used for treating carcinoid syndrome diarrhea in adults inadequately controlled by somatostatin analog therapy.
Dosage:
Xermelo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 250MG BASE | TABLET | Prescription | ORAL |