TASIMELTEON Drug Patent Profile
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Which patents cover Tasimelteon, and when can generic versions of Tasimelteon launch?
Tasimelteon is a drug marketed by Apotex, MSN, and Teva Pharms Usa Inc. and is included in three NDAs.
The generic ingredient in TASIMELTEON is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tasimelteon
A generic version of TASIMELTEON was approved as tasimelteon by TEVA PHARMS USA INC on December 12th, 2022.
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Questions you can ask:
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Summary for TASIMELTEON
Recent Clinical Trials for TASIMELTEON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Saint-Joseph University | Phase 3 |
| Vanda Pharmaceuticals | Phase 2 |
| Vanda Pharmaceuticals | Phase 4 |
Pharmacology for TASIMELTEON
| Drug Class | Melatonin Receptor Agonist |
| Mechanism of Action | Melatonin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for TASIMELTEON
Paragraph IV (Patent) Challenges for TASIMELTEON
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| HETLIOZ LQ | Oral Suspension | tasimelteon | 4 mg/mL | 214517 | 1 | 2024-04-01 |
| HETLIOZ | Capsules | tasimelteon | 20 mg | 205677 | 3 | 2018-01-31 |
US Patents and Regulatory Information for TASIMELTEON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211607-001 | Dec 20, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Msn | TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211654-001 | Jan 12, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa Inc | TASIMELTEON | tasimelteon | CAPSULE;ORAL | 211601-001 | Dec 12, 2022 | 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 |
EU/EMA Drug Approvals for TASIMELTEON
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Vanda Pharmaceuticals Netherlands B.V. | Hetlioz | tasimelteon | EMEA/H/C/003870 Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults., |
Authorised | no | no | yes | 2015-07-03 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
