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Last Updated: December 9, 2019

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Omeprazole; sodium bicarbonate - Generic Drug Details

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What are the generic drug sources for omeprazole; sodium bicarbonate and what is the scope of patent protection?

Omeprazole; sodium bicarbonate is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Zydus Pharms, Salix, and Bayer Healthcare Llc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are one hundred and thirty-one drug master file entries for omeprazole; sodium bicarbonate. Twenty-four suppliers are listed for this compound.

Recent Clinical Trials for omeprazole; sodium bicarbonate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Food and Drug Administration (FDA)Phase 1
BioPharma Services, IncPhase 1
CTC Bio, Inc.Phase 1

See all omeprazole; sodium bicarbonate clinical trials

Recent Litigation for omeprazole; sodium bicarbonate

Identify potential future generic entrants

District Court Litigation
Case NameDate
ERFINDERGEMEINSCHAFT UROPEP GbR v. Eli Lilly and Company2015-07-01
Takeda Pharmaceutical Co v. Impax Laboratories, Inc.2013-11-19
HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.2011-04-21

See all omeprazole; sodium bicarbonate litigation

Paragraph IV (Patent) Challenges for OMEPRAZOLE; SODIUM BICARBONATE
Tradename Dosage Ingredient NDA Submissiondate
ZEGERID OTC CAPSULE;ORAL omeprazole; sodium bicarbonate 022281 2010-04-20
ZEGERID FOR SUSPENSION;ORAL omeprazole; sodium bicarbonate 021636 2007-11-13
ZEGERID FOR SUSPENSION;ORAL omeprazole; sodium bicarbonate 021636 2007-08-24
ZEGERID CAPSULE;ORAL omeprazole; sodium bicarbonate 021849 2007-04-30

US Patents and Regulatory Information for omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204068-002 Jul 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 201946-001 Jul 15, 2016 OTC No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 205545-001 Jul 27, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204922-002 Aug 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204228-001 Jul 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204922-001 Aug 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 AB RX Yes No   Start Trial   Start Trial   Start 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 omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004   Start Trial   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004   Start Trial   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-002 Feb 27, 2006   Start Trial   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004   Start Trial   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004   Start Trial   Start Trial
Bayer Healthcare Llc ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281-001 Dec 1, 2009   Start Trial   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-001 Feb 27, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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