OMEPRAZOLE AND SODIUM BICARBONATE Drug Patent Profile

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Omeprazole And Sodium Bicarbonate is a drug marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma, Zydus, and Zydus Pharms. and is included in fifteen NDAs.

The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE 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.

A generic version of OMEPRAZOLE AND SODIUM BICARBONATE was approved as omeprazole; sodium bicarbonate by STRIDES PHARMA on April 19^th, 2013.

US Patents:	0
Applicants:	11
NDAs:	15
Finished Product Suppliers / Packagers:	25
Clinical Trials:	12
What excipients (inactive ingredients) are in OMEPRAZOLE AND SODIUM BICARBONATE?	OMEPRAZOLE AND SODIUM BICARBONATE excipients list
DailyMed Link:	OMEPRAZOLE AND SODIUM BICARBONATE at DailyMed

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

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 1
BioPharma Services, Inc	Phase 1
Ajou University School of Medicine	Phase 1

Drug Class	Proton Pump Inhibitor Osmotic Laxative
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228-001	Jul 15, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-001	May 25, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	079182-002	Apr 19, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurolife Pharma Llc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204922-002	Aug 19, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Anda Repository	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	212587-002	Apr 30, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	207476-001	Dec 6, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	205545-001	Jul 27, 2016	AB	RX	No	No	⤷ 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