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Last Updated: March 28, 2024

Eszopiclone - Generic Drug Details


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What are the generic sources for eszopiclone and what is the scope of freedom to operate?

Eszopiclone is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Generics, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Orbion Pharms, Sun Pharm, Teva, and Woodward, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for eszopiclone. Thirty-two suppliers are listed for this compound.

Drug Prices for eszopiclone

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Drug Sales Revenue Trends for eszopiclone

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Recent Clinical Trials for eszopiclone

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SponsorPhase
Brigham and Women's HospitalPhase 1/Phase 2
Laboratorios Andromaco S.A.Phase 1
VA Office of Research and DevelopmentPhase 3

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Medical Subject Heading (MeSH) Categories for eszopiclone
Paragraph IV (Patent) Challenges for ESZOPICLONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LUNESTA Tablets eszopiclone 1 mg, 2 mg and 3 mg 021476 10 2008-12-15

US Patents and Regulatory Information for eszopiclone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc ESZOPICLONE eszopiclone TABLET;ORAL 091151-003 Mar 26, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd ESZOPICLONE eszopiclone TABLET;ORAL 202929-002 Jan 30, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc ESZOPICLONE eszopiclone TABLET;ORAL 091151-001 Mar 26, 2013 AB 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

Expired US Patents for eszopiclone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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