Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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NAYZILAM Drug Profile

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

Nayzilam is a drug marketed by Ucb Inc and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in NAYZILAM is midazolam. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the midazolam profile page.

Summary for NAYZILAM
Drug patent expirations by year for NAYZILAM
Generic Entry Opportunity Date for NAYZILAM
Generic Entry Date for NAYZILAM*:
Constraining patent/regulatory exclusivity:
ACUTE TREATMENT 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 12 YEARS OF AGE AND OLDER
NDA:
Dosage:
SPRAY;NASAL

*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.

Pharmacology for NAYZILAM
Drug ClassBenzodiazepine

US Patents and Regulatory Information for NAYZILAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc NAYZILAM midazolam SPRAY;NASAL 211321-001 May 17, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ucb Inc NAYZILAM midazolam SPRAY;NASAL 211321-001 May 17, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ucb Inc NAYZILAM midazolam SPRAY;NASAL 211321-001 May 17, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Colorcon
Medtronic

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 verifification 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.