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Tasimelteon - Generic Drug Details
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What are the generic drug sources for tasimelteon and what is the scope of patent protection?
Tasimelteon
is the generic ingredient in two branded drugs marketed by Vanda Pharms Inc and is included in two NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tasimelteon has one hundred and sixty-two patent family members in thirty-one countries.
There are three drug master file entries for tasimelteon. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for tasimelteon
| International Patents: | 162 |
| US Patents: | 15 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 18 |
| Patent Applications: | 396 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tasimelteon |
| What excipients (inactive ingredients) are in tasimelteon? | tasimelteon excipients list |
| DailyMed Link: | tasimelteon at DailyMed |
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 |
Generic filers with tentative approvals for TASIMELTEON
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 20MG | CAPSULE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for tasimelteon
| Drug Class | Melatonin Receptor Agonist |
| Mechanism of Action | Melatonin Receptor Agonists |
Paragraph IV (Patent) Challenges for TASIMELTEON
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HETLIOZ | CAPSULE;ORAL | tasimelteon | 205677 | 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 LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ | tasimelteon | CAPSULE;ORAL | 205677-001 | Jan 31, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vanda Pharms Inc | HETLIOZ LQ | tasimelteon | SUSPENSION;ORAL | 214517-001 | Dec 1, 2020 | RX | Yes | Yes | 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 |
International Patents for tasimelteon
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2014001992 | Start Trial |
| Chile | 2015001700 | Start Trial |
| South Korea | 20150093236 | Start Trial |
| Japan | 2020079248 | Start Trial |
| South Korea | 102171965 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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