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Last Updated: April 18, 2021

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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

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 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

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Baxter
Harvard Business School
Moodys
Colorcon

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