Zaynich is a drug owned by Wockhardt Bio Ag. It is protected by 7 US drug patents filed in 2026 out of which none have expired yet. Zaynich's patents will be open to challenges from 29 May, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be May 29, 2036. Details of Zaynich's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9834557 | Process For Preparation Of (2S, 5R)-7-Oxo-6-Sulphooxy-2-[((3R)-Piperidine-3-Carbonyl)-Hydrazino Carbonyl]-1,6-Diaza-Bicyclo [3.2.1]-Octane |
Oct, 2033
(7 years from now) | Active |
| US9657021 | Process For Preparation Of (2S, 5R)-7-Oxo-6-Sulphooxy-2[((3R)-Piperidine-3-Carbonyl)-Hydrazino Carbonyl]-1,6-Diaza-Bicyclo [3.2.1]-Octane |
Oct, 2033
(7 years from now) | Active |
| US8822450 | 1,6-Diazabicyclo [3,2,1] Octan-7-One Derivatives And Their Use In The Treatment Of Bacterial Infections |
Aug, 2032
(6 years from now) | Active |
| US8853197 | NA |
Aug, 2032
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9381200 | Nitrogen Containing Compounds |
Aug, 2032
(6 years from now) | Active |
| US9132133 | Nitrogen Containing Compounds |
Aug, 2032
(6 years from now) | Active |
| US9827235 | Pharmaceutical Compositions Comprising Antibacterial Agents |
Aug, 2032
(6 years from now) | Active |
FDA has granted several exclusivities to Zaynich. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Zaynich, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Zaynich.
Exclusivity Information
Zaynich holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2036. Details of Zaynich's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 29, 2031 |
| Generating Antibiotic Incentives Now(GAIN) | May 29, 2036 |
US patents provide insights into the exclusivity only within the United States, but
Zaynich is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Zaynich's family patents as well as insights into
ongoing legal events
on those patents.
Zaynich's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zaynich's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 29, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zaynich Generics:
There are no approved generic versions for Zaynich as of now.
About Zaynich
Zaynich is a drug owned by Wockhardt Bio Ag. Zaynich uses Cefepime Hydrochloride; Zidebactam as an active ingredient. Zaynich was launched by Wockhardt in 2026.
Approval Date:
Zaynich was approved by FDA for market use on 29 May, 2026.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zaynich is 29 May, 2026, its NCE-1 date is estimated to be 29 May, 2030.
Active Ingredient:
Zaynich uses Cefepime Hydrochloride; Zidebactam as the active ingredient. Check out other Drugs and Companies using Cefepime Hydrochloride; Zidebactam ingredient
Dosage:
Zaynich is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2GM BASE/VIAL;1GM/VIAL | POWDER | Prescription | INTRAVENOUS |