ZEGERID Drug Patent Profile
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Which patents cover Zegerid, and when can generic versions of Zegerid launch?
Zegerid is a drug marketed by Salix, Santarus, and Riley Consumer. and is included in five NDAs.
The generic ingredient in ZEGERID is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.
Summary for ZEGERID
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 225 |
Clinical Trials: | 13 |
Patent Applications: | 3,381 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZEGERID |
What excipients (inactive ingredients) are in ZEGERID? | ZEGERID excipients list |
DailyMed Link: | ZEGERID at DailyMed |
Recent Clinical Trials for ZEGERID
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Syndax Pharmaceuticals | Phase 1 |
Population Health Research Institute | Phase 3 |
Norgine | Phase 3 |
Pharmacology for ZEGERID
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZEGERID
Paragraph IV (Patent) Challenges for ZEGERID
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZEGERID | Powder for Oral Suspension | omeprazole; sodium bicarbonate | 20mg/1680mg per packet | 021636 | 1 | 2007-11-13 |
ZEGERID | Powder for Oral Suspension | omeprazole; sodium bicarbonate | 40 mg/1680 mg per packet | 021636 | 1 | 2007-08-24 |
ZEGERID | Capsules | omeprazole; sodium bicarbonate | 20 mg/1100 mg and 40 mg/1100 mg | 021849 | 1 | 2007-04-30 |
US Patents and Regulatory Information for ZEGERID
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-001 | Feb 27, 2006 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | 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 ZEGERID
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Santarus | ZEGERID | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET, CHEWABLE;ORAL | 021850-001 | Mar 24, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Santarus | ZEGERID | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET, CHEWABLE;ORAL | 021850-001 | Mar 24, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZEGERID
See the table below for patents covering ZEGERID around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2003519656 | ⤷ Try a Trial | |
Brazil | 0210971 | ⤷ Try a Trial | |
Poland | 357144 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEGERID
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
0984957 | 122012000017 | Germany | ⤷ Try a Trial | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812 |
1499331 | 13C0055 | France | ⤷ Try a Trial | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |