Generic Faslodex Availability
Faslodex is a brand name of fulvestrant, approved by the FDA in the following formulation(s):
FASLODEX (fulvestrant - injectable; intramuscular)
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Manufacturer: ASTRAZENECA
Approval date: April 25, 2002
Strength(s): 50MG/ML [RLD]
Has a generic version of Faslodex been approved?
No. There is currently no therapeutically equivalent version of Faslodex available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Faslodex. 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.
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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Formulation
Patent 6,774,122
Issued: August 10, 2004
Inventor(s): John R; Evans & Rosalind U; Grundy
Assignee(s): AstraZeneca AB
The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7&agr;-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17&bgr;-diol, more particularly to a formulation adapted for administration by injection containing the compound 7&agr;-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17&bgr;-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.Patent expiration dates:- January 9, 2021✓
- July 9, 2021✓
- January 9, 2021
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Formulation
Patent 7,456,160
Issued: November 25, 2008
Inventor(s): Evans; John R & Grundy; Rosalind U
Assignee(s): AstraZeneca AB
The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.Patent expiration dates:- January 9, 2021✓
- July 9, 2021✓
- January 9, 2021
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Formulation
Patent 8,329,680
Issued: December 11, 2012
Inventor(s): Evans; John R & Grundy; Rosalind U
Assignee(s): AstraZeneca AB
The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.Patent expiration dates:- January 9, 2021✓
- July 9, 2021✓
- January 9, 2021
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:
- September 9, 2013 - CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG
- March 9, 2014 - PEDIATRIC EXCLUSIVITY
- May 17, 2014 - SAFETY, EFFICACY AND PHARMACOKINETIC INFO FOR FASLODEX IN THE PEDIATRIC POPULATION, SPECIFICALLY FOR GIRLS WITH PROGRESSIVE PRECOCIOUS PUBERTY ASSOCIATED WITH MCCUNE-ALBRIGHT SYNDROME ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING
- November 17, 2014 - PEDIATRIC EXCLUSIVITY
- November 9, 2015 - UPDATED RESULTS OF OVERALL SURVIVAL FROM 'CONFIRM' STUDY
See also...
- Faslodex Consumer Information (Drugs.com)
- Faslodex Consumer Information (Wolters Kluwer)
- Faslodex Consumer Information (Cerner Multum)
- Faslodex Advanced Consumer Information (Micromedex)
- Faslodex AHFS DI Monographs (ASHP)
- Fulvestrant Consumer Information (Wolters Kluwer)
- Fulvestrant Consumer Information (Cerner Multum)
- Fulvestrant Intramuscular Advanced Consumer Information (Micromedex)
- Fulvestrant AHFS DI Monographs (ASHP)
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. |
