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Last Updated: April 19, 2024

Naratriptan hydrochloride - Generic Drug Details

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What are the generic sources for naratriptan hydrochloride and what is the scope of patent protection?

Naratriptan hydrochloride is the generic ingredient in two branded drugs marketed by Glaxosmithkline Llc, Ani Pharms, Apotex Corp, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharms, Hikma, Orbion Pharms, Padagis Us, and Sun Pharm Inds Ltd, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for naratriptan hydrochloride. Four suppliers are listed for this compound.

Summary for naratriptan hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	10
Patent Applications:	690
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in naratriptan hydrochloride?	naratriptan hydrochloride excipients list
DailyMed Link:	naratriptan hydrochloride at DailyMed

Recent Clinical Trials for naratriptan hydrochloride

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

Sponsor	Phase
BioHealthonomics Inc.	Phase 2
AgoneX Biopharmaceuticals, Inc.	Phase 2
Ache Laboratorios Farmaceuticos S.A.	Phase 3

See all naratriptan hydrochloride clinical trials

Pharmacology for naratriptan hydrochloride

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 naratriptan hydrochloride

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

US Patents and Regulatory Information for naratriptan hydrochloride

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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
Heritage Pharms	NARATRIPTAN	naratriptan hydrochloride	TABLET;ORAL	200502-001	Feb 28, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex Corp	NARATRIPTAN	naratriptan hydrochloride	TABLET;ORAL	091373-001	Apr 22, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharms	NARATRIPTAN	naratriptan hydrochloride	TABLET;ORAL	200502-002	Feb 28, 2011	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-002	Feb 10, 1998		DISCN	Yes	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 naratriptan hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-002	Feb 10, 1998	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-001	Feb 10, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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