Gimoti is a drug owned by Evoke Pharma Inc. It is protected by 5 US drug patents filed from 2020 to 2023. 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 May 16, 2030. Details of Gimoti'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). | |||
| US8334281 | Nasal formulations of metoclopramide |
May, 2030
(5 years from now) | Active |
| US11020361 | Nasal formulations of metoclopramide |
Dec, 2029
(5 years from now) | Active |
| US11628150 | Nasal formulations of metoclopramide |
Dec, 2029
(5 years from now) | Active |
| US11813231 | Nasal formulations of metoclopramide |
Dec, 2029
(5 years from now) | Active |
| US6770262 | Nasal administration of agents for the treatment of gastroparesis |
Mar, 2021
(3 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 Gimoti's patents.
Latest Legal Activities on Gimoti's Patents
Given below is the list of recent legal activities going on the following patents of Gimoti.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Jun, 2024 | US8334281 |
| Email Notification Critical | 08 Dec, 2023 | US8334281 |
| Change in Power of Attorney (May Include Associate POA) Critical | 08 Dec, 2023 | US8334281 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Dec, 2023 | US11020361 |
| Email Notification Critical | 01 Dec, 2023 | US11813231 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Dec, 2023 | US11628150 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Dec, 2023 | US11813231 |
| Email Notification Critical | 01 Dec, 2023 | US11020361 |
| Email Notification Critical | 01 Dec, 2023 | US11628150 |
| Email Notification Critical | 14 Nov, 2023 | US11813231 |
FDA has granted several exclusivities to Gimoti. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gimoti, 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 Gimoti.
Exclusivity Information
Gimoti holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Gimoti's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 19, 2023 |
US patents provide insights into the exclusivity only within the United States, but Gimoti 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 Gimoti's family patents as well as insights into ongoing legal events on those patents.
Gimoti's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gimoti's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 16, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gimoti Generic API suppliers:
Metoclopramide Hydrochloride is the generic name for the brand Gimoti. 38 different companies have already filed for the generic of Gimoti, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gimoti's generic
How can I launch a generic of Gimoti before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gimoti's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gimoti'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 Gimoti -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg/spray | 30 Dec, 2021 | 1 | 16 May, 2030 |
Alternative Brands for Gimoti
Gimoti which is used for treating diabetic gastroparesis with nasal administration of metoclopramide., has several other brand drugs using the same active ingredient (Metoclopramide Hydrochloride). 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 | |
|---|---|---|
| Meda Pharms |
| |
| Salix Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metoclopramide Hydrochloride, Gimoti's active ingredient. Check the complete list of approved generic manufacturers for Gimoti
About Gimoti
Gimoti is a drug owned by Evoke Pharma Inc. It is used for treating diabetic gastroparesis with nasal administration of metoclopramide. Gimoti uses Metoclopramide Hydrochloride as an active ingredient. Gimoti was launched by Evoke Pharma Inc in 2020.
Approval Date:
Gimoti was approved by FDA for market use on 19 June, 2020.
Active Ingredient:
Gimoti uses Metoclopramide Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metoclopramide Hydrochloride ingredient
Treatment:
Gimoti is used for treating diabetic gastroparesis with nasal administration of metoclopramide.
Dosage:
Gimoti is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 15MG BASE/SPRAY | SPRAY, METERED | Prescription | NASAL |