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NAYZILAM Drug Profile
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See Plans and PricingWhen 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.
US ANDA Litigation and Generic Entry Outlook for Nayzilam
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 17, 2026. This may change due to patent challenges or generic licensing.
There is one tentative approval for the generic drug (midazolam), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for NAYZILAM
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 37 |
| Patent Applications: | 4,238 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NAYZILAM |
| DailyMed Link: | NAYZILAM at DailyMed |
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 Class | Benzodiazepine |
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 | |||
| 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 |
