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 five patents protecting this drug.
This drug has seventy-five patent family members in twenty countries.
The generic ingredient in VALTOCO is diazepam. There are eight drug master file entries for this compound. Thirty-nine 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 4th, 1985.
Summary for VALTOCO
| International Patents: | 75 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 2 |
| 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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for VALTOCO
US Patents and Regulatory Information for VALTOCO
VALTOCO is protected by five US patents and two FDA Regulatory Exclusivities.
Patents protecting VALTOCO
Absorption enhancers for drug administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Administration of benzodiazepine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Administration of benzodiazepine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Absorption enhancers for intranasal administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting VALTOCO
NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing
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: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-003 | Jan 10, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-001 | Jan 10, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2629786 | COMPOSITIONS POUR L'ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) | See Plans and Pricing |
| Germany | 112019000683 | See Plans and Pricing | |
| European Patent Office | 2457580 | Activateurs de l'absorption pour l'administration de médicaments (Absorption enhancers for drug administration) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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