Generic Lutathera Availability
Last updated on Apr 10, 2024.
Lutathera is a brand name of lutetium lu 177 dotatate, approved by the FDA in the following formulation(s):
LUTATHERA (lutetium lu 177 dotatate - solution;intravenous)
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Manufacturer: AAA USA INC
Approval date: January 26, 2018
Strength(s): 10mCi/ML [RLD]
Has a generic version of Lutathera been approved?
No. There is currently no therapeutically equivalent version of Lutathera available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lutathera. 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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Stable, concentrated radionuclide complex solutions
Patent 10,596,276
Issued: March 24, 2020
Inventor(s): de Palo Francesco & Fugazza Lorenza & Barbato Donato & Mariani Maurizio & Chicco Daniela & Tesoriere Giovanni & Brambati Clementina
Assignee(s): ADVANCED ACCELERATOR APPLICATIONS (ITALY) S.R.L.The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.
Patent expiration dates:
- July 25, 2038✓
- July 25, 2038
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Stable, concentrated radionuclide complex solutions
Patent 10,596,278
Issued: March 24, 2020
Inventor(s): de Palo Francesco & Fugazza Lorenza & Barbato Donato & Mariani Maurizio & Chicco Daniela & Tesoriere Giovanni & Brambati Clementina
Assignee(s): ADVANCED ACCELERATOR APPLICATIONS (ITALY) S.R.L.The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.
Patent expiration dates:
- July 25, 2038✓
- July 25, 2038
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Patent 11,904,027
Patent expiration dates:
- July 25, 2038✓
- July 25, 2038
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:
- January 26, 2025 - TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
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Glossary
Term | Definition |
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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.