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Serving leading biopharmaceutical companies globally:

AstraZeneca
Covington
Dow
Chubb
Express Scripts
US Department of Justice
QuintilesIMS
Chinese Patent Office
Fuji
Novartis

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021636

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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-seven drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.
Summary for 021636
Tradename:ZEGERID
Applicant:Santarus Inc
Ingredient:omeprazole; sodium bicarbonate
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 68012-054-30 30 PACKET in 1 CARTON (68012-054-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET

Profile 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 US Patents for NDA 021636

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Subscribe ➤ Subscribe
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Cipla
QuintilesIMS
Citi
Harvard Business School
US Department of Justice
AstraZeneca
UBS
Chinese Patent Office
Mallinckrodt

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