METOCLOPRAMIDE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for metoclopramide hydrochloride and what is the scope of freedom to operate?
Metoclopramide hydrochloride
is the generic ingredient in ten branded drugs marketed by Roxane, Avet Lifesciences, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Hikma, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Teva, Vistapharm, Robins Ah, Evoke Pharma Inc, Novel Labs Inc, Salix Pharms, Meda Pharms, Quantum Pharmics, King Pharms, 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 sixty-five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Metoclopramide hydrochloride has ten patent family members in seven countries.
There are six drug master file entries for metoclopramide hydrochloride. Thirty-two suppliers are listed for this compound.
Summary for METOCLOPRAMIDE HYDROCHLORIDE
International Patents: | 10 |
US Patents: | 4 |
Tradenames: | 10 |
Applicants: | 43 |
NDAs: | 65 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 32 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 266 |
Patent Applications: | 182 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METOCLOPRAMIDE HYDROCHLORIDE |
What excipients (inactive ingredients) are in METOCLOPRAMIDE HYDROCHLORIDE? | METOCLOPRAMIDE HYDROCHLORIDE excipients list |
DailyMed Link: | METOCLOPRAMIDE HYDROCHLORIDE at DailyMed |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bedford | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | INJECTABLE;INJECTION | 072155-001 | Mar 30, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Quantum Pharmics | CLOPRA | metoclopramide hydrochloride | TABLET;ORAL | 070294-001 | Jul 29, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 070184-001 | Jul 29, 1985 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell Molecular | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | SOLUTION;ORAL | 073680-001 | Oct 27, 1992 | 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 |
Expired US Patents for METOCLOPRAMIDE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-001 | Jun 10, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-001 | Jun 10, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-002 | Jun 10, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for METOCLOPRAMIDE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2984736 | FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) | ⤷ Sign Up |
European Patent Office | 2376075 | FORMULATIONS NASALES DE MÉTOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2010075444 | ⤷ Sign Up | |
Denmark | 2376075 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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