REGLAN ODT Drug Patent Profile
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When do Reglan Odt patents expire, and what generic alternatives are available?
Reglan Odt is a drug marketed by Meda Pharms and is included in one NDA.
The generic ingredient in REGLAN ODT is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Reglan Odt
A generic version of REGLAN ODT was approved as metoclopramide hydrochloride by TEVA on July 29th, 1985.
Summary for REGLAN ODT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 34 |
| Patent Applications: | 116 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REGLAN ODT |
| DailyMed Link: | REGLAN ODT at DailyMed |
Recent Clinical Trials for REGLAN ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mercy Health System | Phase 4 |
| Women and Infants Hospital of Rhode Island | Phase 2 |
| Emory University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for REGLAN ODT
US Patents and Regulatory Information for REGLAN ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-001 | Jun 10, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-002 | Jun 10, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 REGLAN ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-002 | Jun 10, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-002 | Jun 10, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-001 | Jun 10, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Meda Pharms | REGLAN ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793-001 | Jun 10, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REGLAN ODT
See the table below for patents covering REGLAN ODT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 6896998 | ⤷ Try a Trial | |
| European Patent Office | 2266538 | Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form) | ⤷ Try a Trial |
| Japan | 5072513 | ⤷ Try a Trial | |
| Spain | 2525720 | ⤷ Try a Trial | |
| Japan | 2008001726 | RAPIDLY DISSOLVING ROBUST DOSAGE FORM | ⤷ Try a Trial |
| Denmark | 2266538 | ⤷ Try a Trial | |
| Denmark | 2147669 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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