Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Citi
Fuji
Chinese Patent Office
McKinsey
Argus Health
QuintilesIMS
Dow
Covington
Novartis
Healthtrust

Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021636

« Back to Dashboard
NDA 021636 describes ZEGERID, which is a drug marketed by Santarus Inc, Santarus, and Bayer Healthcare Llc, and is included in five NDAs. It is available from four suppliers. There are seven patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ZEGERID profile page.

The generic ingredient in ZEGERID is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and thirty-six drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for NDA: 021636

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:7
Formulation / Manufacturing:see details

Pharmacology for NDA: 021636

Suppliers and Packaging for NDA: 021636

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL 021636 NDA Santarus, Inc.. 68012-052 68012-052-30 30 PACKET in 1 CARTON (68012-052-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL 021636 NDA Santarus, Inc.. 68012-054 68012-054-03 3 PACKET in 1 CARTON (68012-054-03) > 1 POWDER, FOR SUSPENSION in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength20MG/PACKET;1.68GM/PACKET
Approval Date:Jun 15, 2004TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jul 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS; MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
Patent:► SubscribePatent Expiration:Jul 15, 2016Product Flag?YSubstance Flag?Delist Request?Y
Patented Use:SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS; MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
Patent:► SubscribePatent Expiration:Jul 15, 2016Product Flag?YSubstance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021636

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Medtronic
Merck
Harvard Business School
Healthtrust
Argus Health
Cerilliant
Baxter
Colorcon

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot