Generic Yondelis Availability
Last updated on Oct 6, 2021.
YONDELIS (trabectedin - powder;intravenous)
Manufacturer: JANSSEN PRODS
Approval date: October 23, 2015
Strength(s): 1MG/VIAL [RLD]
Has a generic version of Yondelis been approved?
No. There is currently no therapeutically equivalent version of Yondelis available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Yondelis. 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.
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.
Pharmaceutical formulations of ecteinascidin compounds
Issued: November 25, 2014
Assignee(s): Pharma Mar, S.A., Sociedad Unipersonal
Ecteinascidin formulations, methods of preparing the same, articles of manufacture and kits with such formulations, and methods of treating proliferative diseases with the same formulations are provided.
Patent expiration dates:
- January 7, 2028✓
- July 7, 2028✓
- January 7, 2028
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:
- April 23, 2021 - PEDIATRIC EXCLUSIVITY
- June 29, 2021 - INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
- December 29, 2021 - PEDIATRIC EXCLUSIVITY
- October 23, 2022 -
- April 23, 2023 - PEDIATRIC EXCLUSIVITY
More about Yondelis (trabectedin)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: alkylating agents
- FDA Approval History
Related treatment guides
|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.|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.