ZEGERID OTC Drug Patent Profile
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When do Zegerid Otc patents expire, and what generic alternatives are available?
Zegerid Otc is a drug marketed by Riley Consumer and is included in two NDAs.
The generic ingredient in ZEGERID OTC is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zegerid Otc
A generic version of ZEGERID OTC was approved as omeprazole; sodium bicarbonate by STRIDES PHARMA on April 19th, 2013.
Summary for ZEGERID OTC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 13 |
| Patent Applications: | 25 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ZEGERID OTC? | ZEGERID OTC excipients list |
| DailyMed Link: | ZEGERID OTC at DailyMed |
Recent Clinical Trials for ZEGERID OTC
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 OTC
| Drug Class | Osmotic Laxative Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Osmotic Activity Proton Pump Inhibitors |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Anatomical Therapeutic Chemical (ATC) Classes for ZEGERID OTC
Paragraph IV (Patent) Challenges for ZEGERID OTC
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZEGERID OTC | Capsules | omeprazole; sodium bicarbonate | 20 mg/1100 mg | 022281 | 1 | 2010-04-20 |
US Patents and Regulatory Information for ZEGERID OTC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | OTC | 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 OTC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZEGERID OTC
See the table below for patents covering ZEGERID OTC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2003519656 | ⤷ Try a Trial | |
| Brazil | 0210971 | ⤷ Try a Trial | |
| Poland | 357144 | ⤷ Try a Trial | |
| European Patent Office | 2201952 | ⤷ Try a Trial | |
| Mexico | PA02006780 | FORMAS DE DOSIS DE BENCIMIDAZOL SUBSTITUIDO NOVEDOSAS Y METODO PARA USAR LAS MISMAS. (NOVEL SUBSTITUTED BENZIMIDAZOLE DOSAGE FORMS AND METHOD OF USING SAME.) | ⤷ Try a Trial |
| European Patent Office | 1927354 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEGERID OTC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | SPC/GB11/013 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >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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