Details for New Drug Application (NDA): 217906
✉ Email this page to a colleague
NDA 217906 describes EMBLAVEO, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the EMBLAVEO profile page.
The generic ingredient in EMBLAVEO is avibactam sodium; aztreonam. One supplier is listed for this compound. Additional details are available on the avibactam sodium; aztreonam profile page.
The generic ingredient in EMBLAVEO is avibactam sodium; aztreonam. One supplier is listed for this compound. Additional details are available on the avibactam sodium; aztreonam profile page.
Summary for 217906
| Tradename: | EMBLAVEO |
| Applicant: | Abbvie |
| Ingredient: | avibactam sodium; aztreonam |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217906
Generic Entry Date for 217906*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
POWDER;INTRAVENOUS |
*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 NDA: 217906
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 217906
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMBLAVEO | avibactam sodium; aztreonam | POWDER;INTRAVENOUS | 217906 | NDA | AbbVie Inc. | 0074-3878 | 0074-3878-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 0.5GM BASE/VIAL;1.5GM/VIAL | ||||
| Approval Date: | Feb 7, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 7, 2033 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Feb 7, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 7, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF COMPLICATED INTRA-ABDOMINAL BACTERIAL INFECTIONS IN ADULT PATIENTS | ||||||||
Complete Access Available with Subscription
