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 and one Paragraph IV challenge.

This drug has ninety-eight 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-seven 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:	98
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	2
Patent Applications:	1,621
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

Paragraph IV (Patent) Challenges for VALTOCO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VALTOCO	Nasal Spray	diazepam	10 mg/spray	211635	1	2024-02-14

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
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Patent Expiration: ⤷ Sign Up

Administration of benzodiazepine compositions
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Patent Expiration: ⤷ Sign Up

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Patent Expiration: ⤷ Sign Up

Administration of benzodiazepine compositions
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Patent Expiration: ⤷ Sign Up

Absorption enhancers for intranasal administration
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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
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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
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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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
Denmark	2381773		⤷ Sign Up
Japan	6941224		⤷ Sign Up
Japan	2021508670	疾患の処置のための鼻腔内エピネフリン製剤及び方法	⤷ Sign Up
Australia	2024201523	Intranasal epinephrine formulations and methods for the treatment of disease	⤷ Sign Up
Japan	2021130663	ベンゾジアゼピン組成物の投与 (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS)	⤷ Sign Up
Brazil	PI0923403	composições para administração de fármaco	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012174158		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration