REGLAN Drug Patent Profile
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When do Reglan patents expire, and what generic alternatives are available?
Reglan is a drug marketed by Hikma, Robins Ah, Ani Pharms, and Meda Pharms. and is included in four NDAs.
The generic ingredient in REGLAN 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
A generic version of REGLAN was approved as metoclopramide hydrochloride by TEVA on July 29th, 1985.
Summary for REGLAN
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 34 |
| Patent Applications: | 4,232 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for REGLAN |
| What excipients (inactive ingredients) are in REGLAN? | REGLAN excipients list |
| DailyMed Link: | REGLAN at DailyMed |
Recent Clinical Trials for REGLAN
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 |
Pharmacology for REGLAN
| Drug Class | Dopamine-2 Receptor Antagonist |
| Mechanism of Action | Dopamine D2 Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for REGLAN
US Patents and Regulatory Information for REGLAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 | ||||
| Ani Pharms | REGLAN | metoclopramide hydrochloride | TABLET;ORAL | 017854-002 | May 5, 1987 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-004 | May 28, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Robins Ah | REGLAN | metoclopramide hydrochloride | SOLUTION;ORAL | 018821-001 | Mar 25, 1983 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | ||||
| Ani Pharms | REGLAN | metoclopramide hydrochloride | TABLET;ORAL | 017854-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-004 | May 28, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
