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. Twelve 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:	12
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	1
Patent Applications:	629
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

Sponsor	Phase
Pfizer	Phase 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
⤷ Sign Up	⤷ Sign Up	40MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	20MG	TABLET; 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

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for eletriptan hydrobromide

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	202040-001	Jun 27, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	210708-002	Jan 15, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	206409-002	Jun 16, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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