Details for New Drug Application (NDA): 220787
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NDA 220787 describes ZAYNICH, which is a drug marketed by Wockhardt Bio Ag 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 ZAYNICH profile page.
The generic ingredient in ZAYNICH is cefepime hydrochloride; zidebactam. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefepime hydrochloride; zidebactam profile page.
The generic ingredient in ZAYNICH is cefepime hydrochloride; zidebactam. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefepime hydrochloride; zidebactam profile page.
Summary for 220787
| Tradename: | ZAYNICH |
| Applicant: | Wockhardt Bio Ag |
| Ingredient: | cefepime hydrochloride; zidebactam |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220787
Generic Entry Date for 220787*:
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: 220787
Suppliers and Packaging for NDA: 220787
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZAYNICH | cefepime hydrochloride; zidebactam | POWDER;INTRAVENOUS | 220787 | NDA | Wockhardt Suisse USA LLC | 87706-866 | 87706-866-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (87706-866-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (87706-866-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 2GM BASE/VIAL;1GM/VIAL | ||||
| Approval Date: | May 29, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 29, 2036 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | May 29, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 8,822,450 | Patent Expiration: | Aug 24, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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