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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Baxter
McKesson
Express Scripts
Harvard Business School

Last Updated: October 26, 2020

DrugPatentWatch Database Preview

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 one branded drug marketed by Vanda Pharms Inc and is included in one NDA. There are thirteen 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 forty-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.

Recent Clinical Trials for tasimelteon

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Saint-Joseph UniversityPhase 3
Vanda PharmaceuticalsPhase 2
Vanda PharmaceuticalsPhase 4

See all tasimelteon clinical trials

Generic filers with tentative approvals for TASIMELTEON
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MGCAPSULE; 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
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 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 Y Y   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Moodys
McKesson
McKinsey
Colorcon

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