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Last Updated: March 28, 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, Hainan Poly, Mylan, 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. Six 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 SUN PHARM on March 18th, 2013.

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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 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hainan Poly ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 215732-001 Feb 10, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657-002 Aug 10, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 202686-001 May 17, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Deva Holding As ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 207181-001 Mar 6, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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