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Last Updated: October 31, 2020

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ESOMEPRAZOLE SODIUM Drug Profile

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When do Esomeprazole Sodium patents expire, and what generic alternatives are available?

Esomeprazole Sodium is a drug marketed by Accord Hlthcare, Aurobindo Pharma Ltd, Deva Holding As, Gland Pharma Ltd, Mylan Labs Ltd, and Sun Pharma Global. and is included in six NDAs.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Esomeprazole Sodium

A generic version of ESOMEPRAZOLE SODIUM was approved as esomeprazole sodium by SUN PHARMA GLOBAL on March 18th, 2013.

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Drug patent expirations by year for ESOMEPRAZOLE SODIUM
Recent Clinical Trials for ESOMEPRAZOLE SODIUM

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SponsorPhase
BioPharma Services, IncPhase 1
Food and Drug Administration (FDA)Phase 1
Chang Gung Memorial HospitalPhase 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
Accord Hlthcare ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 205379-001 Sep 25, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 202686-001 May 17, 2017 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
Mylan Labs Ltd ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 202686-002 May 17, 2017 AP RX 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

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Boehringer Ingelheim

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