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.
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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: | 4,029 |
| 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 |
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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-002 | Feb 27, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|---|---|---|---|
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-001 | Feb 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Santarus | ZEGERID | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET, CHEWABLE;ORAL | 021850-001 | Mar 24, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Cyprus | 1107512 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 03061584 | ⤷ Sign Up | |
| Brazil | 0107565 | ⤷ Sign Up | |
| Japan | 2012136531 | NEW SUBSTITUTED BENZIMIDAZOLE DOSAGE FORM AND METHOD FOR USING THE SAME | ⤷ Sign Up |
| European Patent Office | 1927354 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEGERID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | 300483 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105 |
| 1499331 | 122014000007 | Germany | ⤷ Sign Up | PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Sign Up | 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 |
| 1499331 | C300615 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220 |
| 1411900 | 2011C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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