Cresemba is a drug owned by Astellas Pharma Us Inc. It is protected by 8 US drug patents filed from 2015 to 2023. Out of these, 7 drug patents are active and 1 has expired. Cresemba's patents will be open to challenges from 08 June, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2031. Details of Cresemba'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. | |||
| US6812238 | N-substituted carbamoyloxyalkyl-azolium derivatives |
Oct, 2025
(11 months from now) | Active |
| US10812238 | Configurable reference signals |
Oct, 2025
(11 months from now) | Active |
| US7459561 | N-substituted carbamoyloxyalkyl-azolium derivatives |
Oct, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10603280 (Pediatric) | Active ingredient containing stabilised solid medicinal forms and methods for the production thereof |
Mar, 2028
(3 years from now) | Active |
|
US10206879 (Pediatric) | Active ingredient containing stabilised solid forms and method for the production thereof |
Mar, 2028
(3 years from now) | Active |
| US10603280 | Active ingredient containing stabilised solid medicinal forms and methods for the production thereof |
Sep, 2027
(2 years from now) | Active |
| US10206879 | Active ingredient containing stabilised solid forms and method for the production thereof |
Sep, 2027
(2 years from now) | Active |
|
US6812238 (Pediatric) | N-substituted carbamoyloxyalkyl-azolium derivatives |
May, 2026
(1 year, 5 months 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 Cresemba's patents.
Latest Legal Activities on Cresemba's Patents
Given below is the list of recent legal activities going on the following patents of Cresemba.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Apr, 2024 | US10812238 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Mar, 2024 | US10812238 |
| Email Notification Critical | 04 Mar, 2024 | US10812238 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Sep, 2023 | US10603280 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Aug, 2022 | US10206879 |
| Recordation of Patent Grant Mailed Critical | 20 Oct, 2020 | US10812238 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Oct, 2020 | US10812238 |
| Email Notification Critical | 01 Oct, 2020 | US10812238 |
| Issue Notification Mailed Critical | 30 Sep, 2020 | US10812238 |
| Application Is Considered Ready for Issue Critical | 15 Sep, 2020 | US10812238 |
FDA has granted several exclusivities to Cresemba. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cresemba, 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 Cresemba.
Exclusivity Information
Cresemba holds 12 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Cresemba's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 06, 2020 |
| Orphan Drug Exclusivity(ODE) | Mar 06, 2022 |
| ODE*(ODE*) | Mar 06, 2022 |
| Orphan Drug Exclusivity(ODE-305) | Mar 06, 2022 |
| Orphan Drug Exclusivity(ODE-90) | Mar 06, 2022 |
| New Patient Population(NPP) | Dec 08, 2026 |
| Generating Antibiotic Incentives Now(GAIN) | Sep 06, 2027 |
| Orphan Drug Exclusivity(ODE-453) | Dec 08, 2030 |
| Orphan Drug Exclusivity(ODE-454) | Dec 08, 2030 |
| Orphan Drug Exclusivity(ODE-458) | Dec 08, 2030 |
| Orphan Drug Exclusivity(ODE-459) | Dec 08, 2030 |
| Pediatric Exclusivity(PED) | Jun 08, 2031 |
Several oppositions have been filed on Cresemba's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Cresemba's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cresemba patents.
Cresemba's Oppositions Filed in EPO
Cresemba has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 03, 2010, by Basilea Pharmaceutica International Ag. This opposition was filed on patent number EP07802308A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07802308A | Dec, 2010 | Basilea Pharmaceutica International AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Cresemba 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 Cresemba's family patents as well as insights into ongoing legal events on those patents.
Cresemba's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cresemba's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 08, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cresemba Generics:
There are no approved generic versions for Cresemba as of now.
About Cresemba
Cresemba is a drug owned by Astellas Pharma Us Inc. Cresemba uses Isavuconazonium Sulfate as an active ingredient. Cresemba was launched by Astellas in 2022.
Approval Date:
Cresemba was approved by FDA for market use on 22 November, 2022.
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 Cresemba is 22 November, 2022, its NCE-1 date is estimated to be 08 June, 2030.
Active Ingredient:
Cresemba uses Isavuconazonium Sulfate as the active ingredient. Check out other Drugs and Companies using Isavuconazonium Sulfate ingredient
Dosage:
Cresemba is available in the following dosage forms - powder form for intravenous use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 74.5MG | CAPSULE | Prescription | ORAL |
| 186MG | CAPSULE | Prescription | ORAL |
| 372MG | POWDER | Prescription | INTRAVENOUS |