Generic Cresemba Availability
Last updated on Aug 7, 2024.
Cresemba is a brand name of isavuconazonium, approved by the FDA in the following formulation(s):
CRESEMBA (isavuconazonium sulfate - capsule;oral)
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Manufacturer: ASTELLAS
Approval date: March 6, 2015
Strength(s): 186MG [RLD] -
Manufacturer: ASTELLAS
Approval date: November 22, 2022
Strength(s): 74.5MG [RLD]
CRESEMBA (isavuconazonium sulfate - powder;intravenous)
Has a generic version of Cresemba been approved?
No. There is currently no therapeutically equivalent version of Cresemba available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cresemba. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Active ingredient containing stabilised solid forms and method for the production thereof
Patent 10,206,879
Issued: February 19, 2019
Inventor(s): Gruber Peter & Spickermann Dirk
Assignee(s): Losan Pharma GmbHThe invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.
Patent expiration dates:
- September 14, 2027✓
- September 14, 2027
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Active ingredient containing stabilised solid forms and method for the production thereof
Patent 10206879*PE
Issued: February 19, 2019
Inventor(s): Gruber Peter & Spickermann Dirk
Assignee(s): Losan Pharma GmbHThe invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.
Patent expiration dates:
- March 14, 2028
- March 14, 2028
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Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Patent 10,603,280
Issued: March 31, 2020
Inventor(s): Gruber Peter & Spickermann Dirk
Assignee(s): Losan Pharma GmbHThe invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.
Patent expiration dates:
- September 14, 2027✓
- September 14, 2027
-
Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Patent 10603280*PE
Issued: March 31, 2020
Inventor(s): Gruber Peter & Spickermann Dirk
Assignee(s): Losan Pharma GmbHThe invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.
Patent expiration dates:
- March 14, 2028
- March 14, 2028
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Patent 6,812,238
Patent expiration dates:
- October 31, 2025✓
- October 31, 2025
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Patent 6812238*PED
Patent expiration dates:
- May 1, 2026✓
- May 1, 2026
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- March 6, 2020 - NEW CHEMICAL ENTITY
- September 6, 2020 - PEDIATRIC EXCLUSIVITY
- March 6, 2022 - TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
- March 6, 2022 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- March 6, 2022 - TREATMENT OF INVASIVE ASPERGILLOSIS
- September 6, 2022 - PEDIATRIC EXCLUSIVITY
- September 6, 2025 - GENERATING ANTIBIOTIC INCENTIVES NOW
- December 8, 2026 - NEW PATIENT POPULATION
- June 8, 2027 - PEDIATRIC EXCLUSIVITY
- September 6, 2027 - GENERATING ANTIBIOTIC INCENTIVES NOW
- December 8, 2030 - TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KG AND GREATER
- December 8, 2030 - TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
- December 8, 2030 - TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER
- December 8, 2030 - TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
- June 8, 2031 - PEDIATRIC EXCLUSIVITY
More about Cresemba (isavuconazonium)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (2)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: azole antifungals
- En español
Patient resources
- Cresemba drug information
- Cresemba (Isavuconazonium Intravenous) (Advanced Reading)
- Cresemba (Isavuconazonium Oral) (Advanced Reading)
- Cresemba (Isavuconazonium Sulfate Capsules)
Professional resources
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
