ZEGERID OTC Drug Patent Profile
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Which patents cover Zegerid Otc, and when can generic versions of Zegerid Otc launch?
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-eight 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.
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Questions you can ask:
- What is the 5 year forecast for ZEGERID OTC?
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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: | 24 |
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 |
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 | ⤷ 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 | ||||
>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 | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 022281-001 | Dec 1, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Riley Consumer | ZEGERID OTC | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 022283-001 | Jun 17, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
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 |
>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 | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |