ZANTAC 300 Drug Patent Profile
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When do Zantac 300 patents expire, and when can generic versions of Zantac 300 launch?
Zantac 300 is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in two NDAs.
The generic ingredient in ZANTAC 300 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 300
A generic version of ZANTAC 300 was approved as ranitidine hydrochloride by SANDOZ on August 29th, 1997.
Summary for ZANTAC 300
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 35 |
Clinical Trials: | 22 |
Patent Applications: | 2,243 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ZANTAC 300 at DailyMed |
Recent Clinical Trials for ZANTAC 300
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Food and Drug Administration (FDA) | Phase 1 |
Spaulding Clinical Research LLC | Phase 1 |
Nova Scotia Health Authority | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ZANTAC 300
US Patents and Regulatory Information for ZANTAC 300
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | ZANTAC 300 | ranitidine hydrochloride | CAPSULE;ORAL | 020095-002 | Mar 8, 1994 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | DISCN | Yes | 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 ZANTAC 300
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | ZANTAC 300 | ranitidine hydrochloride | CAPSULE;ORAL | 020095-002 | Mar 8, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ZANTAC 300 | ranitidine hydrochloride | CAPSULE;ORAL | 020095-002 | Mar 8, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ZANTAC 300 | ranitidine hydrochloride | CAPSULE;ORAL | 020095-002 | Mar 8, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ZANTAC 300 | ranitidine hydrochloride | TABLET;ORAL | 018703-002 | Dec 9, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZANTAC 300
See the table below for patents covering ZANTAC 300 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 402069 | ⤷ Try a Trial | |
Ireland | 51604 | AMINOALKYL FURAN DERIVATIVE | ⤷ Try a Trial |
Japan | S6132315 | ⤷ Try a Trial | |
United Kingdom | 1565966 | ⤷ Try a Trial | |
Sweden | 7708521 | ⤷ Try a Trial | |
Philippines | 26972 | Pharmaceutical compositions containing ranitidine | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |