➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
McKinsey
Medtronic
Colorcon
Harvard Business School

Last Updated: August 9, 2020

DrugPatentWatch Database Preview

Esomeprazole sodium - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Esomeprazole sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Aurobindo Pharma Ltd, Deva Holding As, Gland Pharma Ltd, Mylan Labs Ltd, Sun Pharma Global, and Astrazeneca Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-four drug master file entries for esomeprazole sodium. Six suppliers are listed for this compound.

Recent Clinical Trials for esomeprazole sodium

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

SponsorPhase
Food and Drug Administration (FDA)Phase 1
BioPharma Services, IncPhase 1
TTY BiopharmPhase 4

See all esomeprazole sodium clinical trials

Pharmacology for esomeprazole sodium
Paragraph IV (Patent) Challenges for ESOMEPRAZOLE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM IV INJECTABLE;INTRAVENOUS esomeprazole sodium 021689 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
Aurobindo Pharma Ltd ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657-001 Aug 10, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Deva Holding As ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 207181-001 Mar 6, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-001 Mar 31, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 203349-002 Apr 1, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 205379-001 Sep 25, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 200882-001 Mar 18, 2013 DISCN No 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 esomeprazole sodium

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Medtronic
Merck
Mallinckrodt
McKesson

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 verification 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.