ESZOPICLONE Drug Patent Profile
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When do Eszopiclone patents expire, and what generic alternatives are available?
Eszopiclone is a drug 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, and Teva. and is included in fourteen NDAs.
The generic ingredient in ESZOPICLONE is eszopiclone. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Eszopiclone
A generic version of ESZOPICLONE was approved as eszopiclone by TEVA on May 23rd, 2011.
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Questions you can ask:
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Summary for ESZOPICLONE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 33 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 71 |
| Patent Applications: | 3,637 |
| Drug Prices: | Drug price information for ESZOPICLONE |
| Drug Sales Revenues: | Drug sales revenues for ESZOPICLONE |
| DailyMed Link: | ESZOPICLONE at DailyMed |
See drug prices for ESZOPICLONE
Recent Clinical Trials for ESZOPICLONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Phase 2 |
| National Heart, Lung, and Blood Institute (NHLBI) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | ESZOPICLONE | eszopiclone | TABLET;ORAL | 091169-002 | May 23, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nostrum Labs Inc | ESZOPICLONE | eszopiclone | TABLET;ORAL | 203087-002 | May 8, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Pharms Inc | ESZOPICLONE | eszopiclone | TABLET;ORAL | 091151-001 | Mar 26, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nostrum Labs Inc | ESZOPICLONE | eszopiclone | TABLET;ORAL | 203087-003 | May 8, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Pharms Inc | ESZOPICLONE | eszopiclone | TABLET;ORAL | 091151-002 | Mar 26, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | ESZOPICLONE | eszopiclone | TABLET;ORAL | 208451-001 | Sep 15, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
