ESOMEPRAZOLE SODIUM - Generic Drug Details

What are the generic drug sources for esomeprazole sodium and what is the scope of freedom to operate?

Esomeprazole sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Deva Holding As, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Mylan, Sun Pharm, and Astrazeneca, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for esomeprazole sodium. Five suppliers are listed for this compound.

Summary for ESOMEPRAZOLE SODIUM

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	180
Clinical Trials:	8
Patent Applications:	5,205
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESOMEPRAZOLE SODIUM
What excipients (inactive ingredients) are in ESOMEPRAZOLE SODIUM?	ESOMEPRAZOLE SODIUM excipients list
DailyMed Link:	ESOMEPRAZOLE SODIUM at DailyMed

Recent Clinical Trials for ESOMEPRAZOLE SODIUM

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

Sponsor	Phase
Livzon Pharmaceutical Group Inc.	Phase 3
Food and Drug Administration (FDA)	Phase 1
BioPharma Services, Inc	Phase 1

See all ESOMEPRAZOLE SODIUM clinical trials

Pharmacology for ESOMEPRAZOLE SODIUM

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ESOMEPRAZOLE SODIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ESOMEPRAZOLE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXIUM IV	For Injection	esomeprazole sodium	20 mg/vial and 40 mg/vial	021689	1	2009-11-23

US Patents and Regulatory Information for ESOMEPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	202686-002	May 17, 2017		DISCN	No	No
Sun Pharm	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	200882-002	Mar 18, 2013		DISCN	No	No
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005		DISCN	Yes	No
Mylan	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	202686-001	May 17, 2017		DISCN	No	No
Deva Holding As	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	207181-001	Mar 6, 2017	AP	RX	No	No
Gland Pharma Ltd	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	203349-002	Apr 1, 2020	AP	RX	No	No
Hainan Poly	ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	215732-001	Feb 10, 2022	AP	RX	No	Yes

Expired US Patents for ESOMEPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005