ZALEPLON Drug Patent Profile
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Which patents cover Zaleplon, and when can generic versions of Zaleplon launch?
Zaleplon is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs. and is included in ten NDAs.
The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zaleplon
A generic version of ZALEPLON was approved as zaleplon by AUROBINDO PHARMA on June 6th, 2008.
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Summary for ZALEPLON
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 10 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 22 |
Patent Applications: | 3,923 |
Drug Prices: | Drug price information for ZALEPLON |
What excipients (inactive ingredients) are in ZALEPLON? | ZALEPLON excipients list |
DailyMed Link: | ZALEPLON at DailyMed |
Recent Clinical Trials for ZALEPLON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Siriraj Hospital | Phase 4 |
The University of Hong Kong | Phase 3 |
Saint-Joseph University | Phase 3 |
Pharmacology for ZALEPLON
Drug Class | gamma-Aminobutyric Acid A Receptor Agonist |
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Anatomical Therapeutic Chemical (ATC) Classes for ZALEPLON
US Patents and Regulatory Information for ZALEPLON
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | ZALEPLON | zaleplon | CAPSULE;ORAL | 078829-001 | Jun 6, 2008 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Upsher Smith Labs | ZALEPLON | zaleplon | CAPSULE;ORAL | 078706-001 | Jun 6, 2008 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Hikma Pharms | ZALEPLON | zaleplon | CAPSULE;ORAL | 078147-001 | Nov 25, 2008 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Chartwell Molecular | ZALEPLON | zaleplon | CAPSULE;ORAL | 077505-002 | Jun 20, 2008 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Orbion Pharms | ZALEPLON | zaleplon | CAPSULE;ORAL | 090374-002 | Sep 17, 2009 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Upsher Smith Labs | ZALEPLON | zaleplon | CAPSULE;ORAL | 078706-002 | Jun 6, 2008 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Hikma Pharms | ZALEPLON | zaleplon | CAPSULE;ORAL | 078147-002 | Nov 25, 2008 | DISCN | 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 |
EU/EMA Drug Approvals for ZALEPLON
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Meda AB | Sonata | zaleplon | EMEA/H/C/000227 Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress. |
Withdrawn | no | no | no | 1999-03-12 | |
Meda AB | Zerene | zaleplon | EMEA/H/C/000228 Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress. |
Withdrawn | no | no | no | 1999-03-12 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
ZALEPLON Market Analysis and Financial Projection Experimental
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