tasimelteon - Profile
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What are the generic sources for tasimelteon and what is the scope of patent protection?
Tasimelteon
is the generic ingredient in three branded drugs marketed by Vanda Pharms Inc, Apotex, MSN, and Teva Pharms Usa Inc, and is included in five NDAs. There are thirty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tasimelteon has two hundred and seventeen patent family members in twenty-four countries.
Summary for tasimelteon
| International Patents: | 217 |
| US Patents: | 33 |
| Tradenames: | 3 |
| Applicants: | 4 |
| NDAs: | 5 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 9,539,234 | ⤷ Start Trial | ⤷ Start Trial | |||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 9,855,241 | ⤷ Start Trial | ⤷ Start Trial | |||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | RE46604 | ⤷ Start Trial | ⤷ Start Trial | |||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 10,149,829 | ⤷ Start Trial | ⤷ Start Trial | |||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 9,730,910 | ⤷ Start Trial | ⤷ Start Trial | |||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | AB | RX | Yes | Yes | 9,060,995 | ⤷ 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 |
Expired US Patents for tasimelteon
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | 5,856,529 | ⤷ Start Trial |
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | 5,856,529 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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/003870Hetlioz 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 |
International Patents for tasimelteon
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3105212 | TASIMELTÉON DE QUALITÉ PHARMACEUTIQUE, HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| European Patent Office | 3470405 | TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉE (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| European Patent Office | 4223747 | TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| Japan | 2017506642 | 高純度医薬品等級タシメルテオン | ⤷ Start Trial |
| Japan | 2020079248 | 高純度医薬品等級タシメルテオン (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON) | ⤷ Start Trial |
| Japan | 2022088624 | 高純度医薬品等級タシメルテオン | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
