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-eight 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.
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Questions you can ask:
- What is the 5 year forecast for VALTOCO?
- What are the global sales for VALTOCO?
- What is Average Wholesale Price for VALTOCO?
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: | 4,152 |
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 |
Pharmacology for VALTOCO
Drug Class | Benzodiazepine |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Administration of benzodiazepine compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Administration of benzodiazepine compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Absorption enhancers for intranasal administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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 | ||||
>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 |
---|---|---|---|
Australia | 2011317202 | Compositions for drug administration | ⤷ Sign Up |
Spain | 2935684 | ⤷ Sign Up | |
Lithuania | 3678649 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |