Generic Synribo Availability
SYNRIBO (omacetaxine mepesuccinate - powder;subcutaneous)
Manufacturer: IVAX INTL
Approval date: October 26, 2012
Strength(s): 3.5MG/VIAL [RLD]
Has a generic version of Synribo been approved?
No. There is currently no therapeutically equivalent version of Synribo available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Synribo. 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: About generic drugs.
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.
Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Issued: January 17, 2006
Inventor(s): Robin; Jean-Pierre & Mahon; François-Xavier & Maisonneuve; Hervé & Maloisel; Frederick & Blanchard; Julie
Assignee(s): Stragen Pharma S.A.
The present invention concerns a method of treating chronic myelogenous leukemia, a related myeloproliferative disorder or a Ph-positive acute lymphocytic leukemia in a subject animal, comprising: (a) selecting or identifying an animal suffering from chronic myelogenous leukemia or a related myeloproliferative disorder and showing resistance or intolerance to treatment with STI571; and (b) administering to the animal homoharringtonine. In a preferred embodiment, the animal is a human being.Patent expiration dates:
- June 28, 2023✓
- June 28, 2023
Cephalotaxane derivatives and their processes of preparation and purification
Issued: September 9, 2014
Assignee(s): IVAX International GmbH
The present invention concerns a new general process for asymmetric hemisynthesis of harringtonines and their analogs, that are alkaloids used in chemotherapy. This process comprises direct esterification of a natural cephalotaxine with an acylating compound constituted of a side chain precursor which backbone and functionalization are entirely preformed. The invention also concerns a natural, synthetic or semi-synthetic harringtonines including their tautomeric forms and their salts of the following formula: wherein n=2 (i.e. harringtonine) or n=3 (i.e. homoharringtonine), in which the total content of impurities, possibly including enantiomeric forms, is lower than 1%, and/or the content of the major impurity is lower than 0.9%, and/or the chromatographic assay exhibits a harringtonines content higher than 97.5%.Patent expiration dates:
- March 16, 2019✓✓✓
- March 16, 2019
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:
- October 26, 2017 - NEW CHEMICAL ENTITY
- October 26, 2019 - ORPHAN DRUG EXCLUSIVITY
More about Synribo (omacetaxine)
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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.|