ZANTAC 25 Drug Patent Profile
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When do Zantac 25 patents expire, and what generic alternatives are available?
Zantac 25 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.
The generic ingredient in ZANTAC 25 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zantac 25
A generic version of ZANTAC 25 was approved as ranitidine hydrochloride by SANDOZ on August 29th, 1997.
Summary for ZANTAC 25
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 22 |
Patent Applications: | 2,243 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ZANTAC 25 at DailyMed |
Recent Clinical Trials for ZANTAC 25
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Spaulding Clinical Research LLC | Phase 1 |
Food and Drug Administration (FDA) | Phase 1 |
Nova Scotia Health Authority | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ZANTAC 25
US Patents and Regulatory Information for ZANTAC 25
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ZANTAC 25 | ranitidine hydrochloride | TABLET, EFFERVESCENT;ORAL | 020251-003 | Apr 1, 2004 | 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 |
International Patents for ZANTAC 25
See the table below for patents covering ZANTAC 25 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1077 | AMINOALKYL FURAN DERIVATIVES | ⤷ Try a Trial |
Spain | 470836 | ⤷ Try a Trial | |
Singapore | 21892 | ⤷ Try a Trial | |
Denmark | 148258 | ⤷ Try a Trial | |
Philippines | 21761 | PHARMACEUTICAL COMPOSITION CONTAINING FORM 2 RANITIDINE HYDROCHLORIDE AND PROCESS OF PREPARATION THEREOF | ⤷ Try a Trial |
France | 2491067 | ⤷ Try a Trial | |
France | 2633181 | COMPOSITION PHARMACEUTIQUE A BASE DE RANITIDINE ET SON PROCEDE DE PREPARATION | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |