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Last Updated: March 19, 2024

Eletriptan hydrobromide - Generic Drug Details


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What are the generic drug sources for eletriptan hydrobromide and what is the scope of freedom to operate?

Eletriptan hydrobromide is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Aurobindo Pharma, Beximco Pharms Usa, Mylan, Stevens J, Teva Pharms Usa, Yung Shin Pharm, Zydus Pharms, and Upjohn, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for eletriptan hydrobromide. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for eletriptan hydrobromide
US Patents:0
Tradenames:2
Applicants:9
NDAs:9
Drug Master File Entries: 11
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 70
Clinical Trials: 1
Patent Applications: 659
What excipients (inactive ingredients) are in eletriptan hydrobromide?eletriptan hydrobromide excipients list
DailyMed Link:eletriptan hydrobromide at DailyMed
Recent Clinical Trials for eletriptan hydrobromide

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

SponsorPhase
PfizerPhase 1
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Phase 1

See all eletriptan hydrobromide clinical trials

Generic filers with tentative approvals for ELETRIPTAN HYDROBROMIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial20MGTABLET; 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 eletriptan hydrobromide
Paragraph IV (Patent) Challenges for ELETRIPTAN HYDROBROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RELPAX Tablets eletriptan hydrobromide 20 mg and 40 mg 021016 1 2010-03-29

US Patents and Regulatory Information for eletriptan hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Stevens J ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 206787-002 May 25, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Stevens J ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 206787-001 May 25, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 205152-002 Aug 11, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide TABLET;ORAL 202040-001 Jun 27, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 eletriptan hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn RELPAX eletriptan hydrobromide TABLET;ORAL 021016-002 Dec 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn RELPAX eletriptan hydrobromide TABLET;ORAL 021016-002 Dec 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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