GIMOTI Drug Patent Profile
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Which patents cover Gimoti, and when can generic versions of Gimoti launch?
Gimoti is a drug marketed by Evoke Pharma Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has ten patent family members in seven countries.
The generic ingredient in GIMOTI is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gimoti
A generic version of GIMOTI was approved as metoclopramide hydrochloride by TEVA on July 29th, 1985.
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Summary for GIMOTI
| International Patents: | 10 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Patent Applications: | 1,385 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GIMOTI |
| What excipients (inactive ingredients) are in GIMOTI? | GIMOTI excipients list |
| DailyMed Link: | GIMOTI at DailyMed |
Pharmacology for GIMOTI
| Drug Class | Dopamine-2 Receptor Antagonist |
| Mechanism of Action | Dopamine D2 Antagonists |
Paragraph IV (Patent) Challenges for GIMOTI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GIMOTI | Metered Nasal Spray | metoclopramide hydrochloride | 15 mg/spray | 209388 | 1 | 2021-12-30 |
US Patents and Regulatory Information for GIMOTI
GIMOTI is protected by four US patents.
Patents protecting GIMOTI
Nasal formulations of metoclopramide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
Nasal formulations of metoclopramide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Evoke Pharma Inc | GIMOTI | metoclopramide hydrochloride | SPRAY, METERED;NASAL | 209388-001 | Jun 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Evoke Pharma Inc | GIMOTI | metoclopramide hydrochloride | SPRAY, METERED;NASAL | 209388-001 | Jun 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Evoke Pharma Inc | GIMOTI | metoclopramide hydrochloride | SPRAY, METERED;NASAL | 209388-001 | Jun 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Evoke Pharma Inc | GIMOTI | metoclopramide hydrochloride | SPRAY, METERED;NASAL | 209388-001 | Jun 19, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GIMOTI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Evoke Pharma Inc | GIMOTI | metoclopramide hydrochloride | SPRAY, METERED;NASAL | 209388-001 | Jun 19, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GIMOTI
See the table below for patents covering GIMOTI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 2376075 | ⤷ Sign Up | |
| European Patent Office | 2376075 | FORMULATIONS NASALES DE MÉTOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) | ⤷ Sign Up |
| South Korea | 20030004361 | ⤷ Sign Up | |
| Denmark | 1274414 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2010075444 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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