eszopiclone - Profile
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What are the generic drug 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 Pharms Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orbion Pharms, Pharmobedient, Sun Pharm, Teva, and Waylis Therap, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.Summary for eszopiclone
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 15 |
| NDAs: | 15 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | ESZOPICLONE | eszopiclone | TABLET;ORAL | 208451-001 | Sep 15, 2016 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aurobindo Pharma | ESZOPICLONE | eszopiclone | TABLET;ORAL | 208451-002 | Sep 15, 2016 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aurobindo Pharma | ESZOPICLONE | eszopiclone | TABLET;ORAL | 208451-003 | Sep 15, 2016 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Chartwell Rx | ESZOPICLONE | eszopiclone | TABLET;ORAL | 091165-001 | Jul 14, 2011 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chartwell Rx | ESZOPICLONE | eszopiclone | TABLET;ORAL | 091165-002 | Jul 14, 2011 | DISCN | 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 |
