METOCLOPRAMIDE HYDROCHLORIDE Drug Patent Profile
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When do Metoclopramide Hydrochloride patents expire, and what generic alternatives are available?
Metoclopramide Hydrochloride is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm, Novel Labs Inc, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs. and is included in fifty-three NDAs.
The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Metoclopramide Hydrochloride
A generic version of METOCLOPRAMIDE HYDROCHLORIDE was approved as metoclopramide hydrochloride by TEVA on July 29th, 1985.
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Questions you can ask:
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Summary for METOCLOPRAMIDE HYDROCHLORIDE
Recent Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Health Sciences North Research Institute | N/A |
| Wollo University | Phase 4 |
| Adwia Pharma, Egypt | Phase 3 |
Pharmacology for METOCLOPRAMIDE HYDROCHLORIDE
| Drug Class | Dopamine-2 Receptor Antagonist |
| Mechanism of Action | Dopamine D2 Antagonists |
Medical Subject Heading (MeSH) Categories for METOCLOPRAMIDE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for METOCLOPRAMIDE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for METOCLOPRAMIDE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GIMOTI | Metered Nasal Spray | metoclopramide hydrochloride | 15 mg/spray | 209388 | 1 | 2021-12-30 |
| METOZOLV ODT | Orally Disintegrating Tablets | metoclopramide hydrochloride | 5 mg and 10 mg | 022246 | 1 | 2010-08-24 |
US Patents and Regulatory Information for METOCLOPRAMIDE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mutual Pharm | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 070660-001 | Feb 10, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 074478-001 | Oct 5, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 070581-001 | Oct 17, 1985 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 070645-001 | May 11, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
