Gimoti Patent Expiration

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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6770262 Nasal administration of agents for the treatment of gastroparesis
Mar, 2021

(3 years ago)

Expired
US11628150 Nasal formulations of metoclopramide
Dec, 2029

(5 years from now)

Active
US11813231 Nasal formulations of metoclopramide
Dec, 2029

(5 years from now)

Active
US11020361 Nasal formulations of metoclopramide
Dec, 2029

(5 years from now)

Active
US8334281 Nasal formulations of metoclopramide
May, 2030

(5 years from now)

Active


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

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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

Gimoti has patent protection in a total of 7 countries. It has a significant patent presence in the US with 55.6% of its patents being US patents. Click below to unlock the full patent family tree for Gimoti.

Family Patents

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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 Generics:

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




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.

Market Authorisation 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