Doptelet is a drug owned by Akarx Inc. It is protected by 3 US drug patents filed from 2018 to 2019. Out of these, 1 drug patents are active and 2 have expired. Doptelet's patents have been open to challenges since 21 May, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 28, 2027. Details of Doptelet'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. | |||
| US7638536 | 2-Acylaminothiazole derivative or salt thereof |
Jul, 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). | |||
| US8338429 | 2-acylaminothiazole derivative or salt thereof |
Jun, 2023
(1 year, 10 months ago) |
Expired
|
| US8765764 | 2-acylaminothiazole derivative or salt thereof |
Jan, 2023
(2 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 Doptelet's patents.
Latest Legal Activities on Doptelet's Patents
Given below is the list of recent legal activities going on the following patents of Doptelet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 08 Jan, 2024 | US7638536 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 26 Dec, 2023 | US7638536 |
| Requirement for information sent under 37 CFR 1.750 | 08 Dec, 2023 | US7638536 |
| Notice of Final Determination -Eligible | 16 Nov, 2023 | US7638536 |
| FDA Final Eligibility Letter Critical | 14 Nov, 2023 | US7638536 |
| transaction for FDA Determination of Regulatory Review Period | 06 Feb, 2023 | US7638536 |
| Information Disclosure Statement (IDS) Filed Critical | 02 Feb, 2023 | US7638536 |
| transaction for FDA Determination of Regulatory Review Period | 02 Feb, 2023 | US7638536 |
| Interim Patent Term Extension Granted Critical | 11 Jan, 2023 | US7638536 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 09 Jan, 2023 | US7638536 |
FDA has granted several exclusivities to Doptelet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Doptelet, 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 Doptelet.
Exclusivity Information
Doptelet holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Doptelet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-802) | Jun 26, 2022 |
| New Chemical Entity Exclusivity(NCE) | May 21, 2023 |
| Orphan Drug Exclusivity(ODE-246) | Jun 26, 2026 |
US patents provide insights into the exclusivity only within the United States, but Doptelet 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 Doptelet's family patents as well as insights into ongoing legal events on those patents.
Doptelet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Doptelet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 28, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Doptelet Generics:
There are no approved generic versions for Doptelet as of now.
About Doptelet
Doptelet is a drug owned by Akarx Inc. It is used for managing thrombocytopenia in adult patients with chronic immune thrombocytopenia or chronic liver disease scheduled for a procedure. Doptelet uses Avatrombopag Maleate as an active ingredient. Doptelet was launched by Akarx Inc in 2018.
Approval Date:
Doptelet was approved by FDA for market use on 21 May, 2018.
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 Doptelet is 21 May, 2018, its NCE-1 date is estimated to be 21 May, 2022.
Active Ingredient:
Doptelet uses Avatrombopag Maleate as the active ingredient. Check out other Drugs and Companies using Avatrombopag Maleate ingredient
Treatment:
Doptelet is used for managing thrombocytopenia in adult patients with chronic immune thrombocytopenia or chronic liver disease scheduled for a procedure.
Dosage:
Doptelet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |