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Last Updated: August 13, 2020

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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 Inc, Apotex Corp, Chartwell Rx, Heritage Pharms Inc, Hikma, Mylan Pharms Inc, Orchid Hlthcare, Paddock Llc, 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.

Recent Clinical Trials for naratriptan hydrochloride

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

SponsorPhase
BioHealthonomics Inc.Phase 2
Ache Laboratorios Farmaceuticos S.A.Phase 3
Roxane LaboratoriesN/A

See all naratriptan hydrochloride clinical trials

Pharmacology for naratriptan hydrochloride

US Patents and Regulatory Information for naratriptan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc AMERGE naratriptan hydrochloride TABLET;ORAL 020763-001 Feb 10, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Chartwell Rx NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090288-001 Jul 7, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 078751-002 Jul 7, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Chartwell Rx NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090288-002 Jul 7, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090381-002 Jul 7, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 091552-001 Feb 14, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Corp NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 091373-002 Apr 22, 2011 DISCN No No   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

Expired US Patents for naratriptan hydrochloride

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Boehringer Ingelheim
Medtronic
Baxter
Colorcon

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