Generic Hycamtin Availability
Last updated on Aug 7, 2024.
Hycamtin is a brand name of topotecan, approved by the FDA in the following formulation(s):
HYCAMTIN (topotecan hydrochloride - capsule;oral)
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Manufacturer: SANDOZ
Approval date: October 11, 2007
Strength(s): EQ 0.25MG BASE [RLD], EQ 1MG BASE [RLD]
Has a generic version of Hycamtin been approved?
No. There is currently no therapeutically equivalent version of Hycamtin available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Hycamtin. 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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Compound, corresponding compositions, preparation and/or treatment methods
Patent 8,158,645
Issued: April 17, 2012
Inventor(s): "DellOrco Philip C." & Diederich Ann Marie & Su Qiaogong & Wood Jeffery Lee
Assignee(s): GlaxoSmithKline LLCDisclosed is a novel crystalline form of topotecan monohydrochloride pentahydrate, which is a pentahydrate of 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)dione monohydrochloride, corresponding pharmaceutical compositions, methods preparation and/or use thereof to treat anti-viral and/or cancer-related diseases.
Patent expiration dates:
- December 10, 2024✓
- December 10, 2024
More about Hycamtin (topotecan)
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- During pregnancy
- Drug class: miscellaneous antineoplastics
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Patient resources
- Hycamtin oral/injection drug information
- Hycamtin (Topotecan Intravenous) (Advanced Reading)
- Hycamtin (Topotecan Oral) (Advanced Reading)
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.
