Zemdri is a drug owned by Cipla Usa Inc. It is protected by 4 US drug patents filed in 2018 out of which none have expired yet. Zemdri's patents will be open to challenges from 26 June, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2031. Details of Zemdri'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. | |||
| US8383596 | Antibacterial aminoglycoside analogs |
Jun, 2031
(6 years from now) | Active |
| US9688711 | Antibacterial aminoglycoside analogs |
Nov, 2028
(3 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). | |||
| US8822424 | Antibacterial aminoglycoside analogs |
Nov, 2028
(3 years from now) | Active |
| US9266919 | Antibacterial aminoglycoside analogs |
Nov, 2028
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zemdri's patents.
Latest Legal Activities on Zemdri's Patents
Given below is the list of recent legal activities going on the following patents of Zemdri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| FDA Final Eligibility Letter Critical | 30 Jan, 2024 | US8383596 |
| FDA Final Eligibility Letter Critical | 30 Jan, 2024 | US8822424 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 23 Aug, 2023 | US9266919 |
| transaction for FDA Determination of Regulatory Review Period | 15 May, 2023 | US8383596 |
| transaction for FDA Determination of Regulatory Review Period | 15 May, 2023 | US8822424 |
| transaction for FDA Determination of Regulatory Review Period | 18 Apr, 2023 | US8383596 |
| transaction for FDA Determination of Regulatory Review Period | 18 Apr, 2023 | US8822424 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 02 Mar, 2022 | US8822424 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 28 Dec, 2020 | US9688711 |
| Second letter to regulating agency to determine regulatory review period | 24 Sep, 2020 | US8383596 |
FDA has granted several exclusivities to Zemdri. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zemdri, 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 Zemdri.
Exclusivity Information
Zemdri holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Zemdri's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 25, 2023 |
| Generating Antibiotic Incentives Now(GAIN) | Jun 25, 2028 |
US patents provide insights into the exclusivity only within the United States, but Zemdri 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 Zemdri's family patents as well as insights into ongoing legal events on those patents.
Zemdri's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zemdri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 02, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zemdri Generics:
There are no approved generic versions for Zemdri as of now.
About Zemdri
Zemdri is a drug owned by Cipla Usa Inc. It is used for treating bacterial infections. Zemdri uses Plazomicin Sulfate as an active ingredient. Zemdri was launched by Cipla Usa in 2018.
Approval Date:
Zemdri was approved by FDA for market use on 25 June, 2018.
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 Zemdri is 25 June, 2018, its NCE-1 date is estimated to be 26 June, 2027.
Active Ingredient:
Zemdri uses Plazomicin Sulfate as the active ingredient. Check out other Drugs and Companies using Plazomicin Sulfate ingredient
Treatment:
Zemdri is used for treating bacterial infections.
Dosage:
Zemdri is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |