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Last Updated: March 28, 2024

Viloxazine hydrochloride - Generic Drug Details


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What are the generic sources for viloxazine hydrochloride and what is the scope of freedom to operate?

Viloxazine hydrochloride is the generic ingredient in one branded drug marketed by Supernus Pharms and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Viloxazine hydrochloride has twenty-one patent family members in seven countries.

One supplier is listed for this compound.

Summary for viloxazine hydrochloride
International Patents:21
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 89
Clinical Trials: 11
Patent Applications: 272
What excipients (inactive ingredients) are in viloxazine hydrochloride?viloxazine hydrochloride excipients list
DailyMed Link:viloxazine hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for viloxazine hydrochloride
Generic Entry Date for viloxazine hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for viloxazine hydrochloride

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

SponsorPhase
ApnimedPhase 2
Supernus Pharmaceuticals, Inc.Phase 4
Supernus Pharmaceuticals, Inc.Phase 3

See all viloxazine hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for viloxazine hydrochloride

US Patents and Regulatory Information for viloxazine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-003 Apr 2, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-001 Apr 2, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-003 Apr 2, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-001 Apr 2, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-001 Apr 2, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supernus Pharms QELBREE viloxazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964-001 Apr 2, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

International Patents for viloxazine hydrochloride

Country Patent Number Title Estimated Expiration
Australia 2020233746 Modified release formulations of viloxazine ⤷  Try a Trial
Spain 2459322 ⤷  Try a Trial
Australia 2019216707 Modified release formulations of viloxazine ⤷  Try a Trial
Japan 2018090601 ビロキサジンの緩和放出製剤 (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE) ⤷  Try a Trial
Mexico 356727 FORMULACIONES DE LIBERACION MODIFICADA DE VILOXACINA. (MODIFIED RELEASE FORMULATIONS OF VILOXAZINE.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013119794 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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