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Last Updated: August 13, 2020

DrugPatentWatch Database Preview

ESOMEPRAZOLE SODIUM - Generic Drug Details

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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, 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
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
Aurobindo Pharma Ltd ESOMEPRAZOLE SODIUM esomeprazole sodium INJECTABLE;INTRAVENOUS 204657-001 Aug 10, 2016 DISCN 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
>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 021689-001 Mar 31, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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