VALTOCO Drug Patent Profile

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When do Valtoco patents expire, and what generic alternatives are available?

Valtoco is a drug marketed by Neurelis Inc and is included in one NDA. There are six patents protecting this drug.

This drug has ninety-seven patent family members in twenty-eight countries.

The generic ingredient in VALTOCO is diazepam. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Valtoco

A generic version of VALTOCO was approved as diazepam by MYLAN on September 4^th, 1985.

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Summary for VALTOCO

International Patents:	97
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	2
Patent Applications:	4,156
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VALTOCO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALTOCO
What excipients (inactive ingredients) are in VALTOCO?	VALTOCO excipients list
DailyMed Link:	VALTOCO at DailyMed

Drug patent expirations by year for VALTOCO

Recent Clinical Trials for VALTOCO

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

Sponsor	Phase
University of Cincinnati	Phase 4
Neurelis, Inc.	Phase 1/Phase 2

See all VALTOCO clinical trials

Pharmacology for VALTOCO

Drug Class	Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for VALTOCO

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for VALTOCO

VALTOCO is protected by six US patents and one FDA Regulatory Exclusivity.

Patents protecting VALTOCO

Absorption enhancers for drug administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Administration of benzodiazepine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Administration of benzodiazepine compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Absorption enhancers for intranasal administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: NASAL ADMINISTRATION OF DIAZEPAM FOR TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PATIENTS 6 YEARS OF AGE AND OLDER

Pharmaceutical composition including alkyl glycoside and an anti-seizure agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting VALTOCO

INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial

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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
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		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 VALTOCO

See the table below for patents covering VALTOCO around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2019163273	ベンゾジアゼピン組成物の投与 (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS)	⤷ Try a Trial
Japan	2012513412		⤷ Try a Trial
Spain	2586032		⤷ Try a Trial
South Korea	20240019858	비강내 에피네프린 제제 및 질환의 치료 방법 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)	⤷ Try a Trial
European Patent Office	4169511	FORMULATIONS D'ÉPINÉPHRINE INTRANASALES ET MÉTHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)	⤷ Try a Trial
Japan	5752048		⤷ Try a Trial
European Patent Office	2629786	COMPOSITIONS POUR L'ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration