ESZOPICLONE - Generic Drug Details
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What are the generic sources for eszopiclone and what is the scope of patent protection?
Eszopiclone
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, 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 Waylis Therap, 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-four suppliers are listed for this compound.
Summary for ESZOPICLONE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 15 |
NDAs: | 15 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 34 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 71 |
Patent Applications: | 6,618 |
Drug Prices: | Drug price trends for ESZOPICLONE |
Drug Sales Revenues: | Drug sales revenues for ESZOPICLONE |
What excipients (inactive ingredients) are in ESZOPICLONE? | ESZOPICLONE excipients list |
DailyMed Link: | ESZOPICLONE at DailyMed |
Recent Clinical Trials for ESZOPICLONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
University of California, Los Angeles | Phase 2 |
Siriraj Hospital | Phase 4 |
Medical Subject Heading (MeSH) Categories for ESZOPICLONE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | ESZOPICLONE | eszopiclone | TABLET;ORAL | 205504-003 | Jan 4, 2024 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Hetero Labs Ltd V | ESZOPICLONE | eszopiclone | TABLET;ORAL | 205504-002 | Jan 4, 2024 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Chartwell Rx | ESZOPICLONE | eszopiclone | TABLET;ORAL | 091165-001 | Jul 14, 2011 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Ipca Labs Ltd | ESZOPICLONE | eszopiclone | TABLET;ORAL | 206222-003 | Dec 29, 2023 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Hetero Labs Ltd V | ESZOPICLONE | eszopiclone | TABLET;ORAL | 205504-001 | Jan 4, 2024 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 |
---|---|---|---|---|---|---|---|
Waylis Therap | LUNESTA | eszopiclone | TABLET;ORAL | 021476-003 | Dec 15, 2004 | 6,444,673*PED | ⤷ Subscribe |
Waylis Therap | LUNESTA | eszopiclone | TABLET;ORAL | 021476-002 | Dec 15, 2004 | 6,319,926*PED | ⤷ Subscribe |
Waylis Therap | LUNESTA | eszopiclone | TABLET;ORAL | 021476-003 | Dec 15, 2004 | 6,319,926*PED | ⤷ Subscribe |
Waylis Therap | LUNESTA | eszopiclone | TABLET;ORAL | 021476-001 | Dec 15, 2004 | 6,319,926*PED | ⤷ Subscribe |
Waylis Therap | LUNESTA | eszopiclone | TABLET;ORAL | 021476-002 | Dec 15, 2004 | 6,864,257*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
ESZOPICLONE Market Analysis and Financial Projection Experimental
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