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 |
|---|---|---|---|
| Poland | 374832 | ⤷ Try a Trial | |
| Brazil | 0107565 | ⤷ 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 |
|---|---|---|---|---|
| 0984957 | CR 2012 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
| 0984957 | C300517 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812 |
| 0984957 | 1290006-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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