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Last Updated: November 2, 2024

ESOMEPRAZOLE SODIUM Drug Patent 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, Deva Holding As, Eugia Pharma, Gland Pharma Ltd, Mylan, Slate Run Pharma, and Sun Pharm. and is included in seven NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Esomeprazole Sodium

A generic version of ESOMEPRAZOLE SODIUM was approved as esomeprazole sodium by EUGIA PHARMA on August 10th, 2016.

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

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

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

See all ESOMEPRAZOLE SODIUM clinical trials

Pharmacology for ESOMEPRAZOLE SODIUM
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
Accord Hlthcare ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 205379-001 Sep 25, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 202686-001 May 17, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657-002 Aug 10, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 202686-002 May 17, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Deva Holding As ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 207181-001 Mar 6, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657-001 Aug 10, 2016 DISCN 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

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