Generic Qfitlia Availability
Last updated on Aug 6, 2025.
Qfitlia is a brand name of fitusiran, approved by the FDA in the following formulation(s):
QFITLIA (fitusiran sodium - solution;subcutaneous)
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Manufacturer: GENZYME CORP
Approval date: March 28, 2025
Strength(s): EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) [RLD], EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) [RLD]
Is there a generic version of Qfitlia available?
No. There is currently no therapeutically equivalent version of Qfitlia available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qfitlia. 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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Methods and compositions for treating a Serpinc1-associated disorder
Patent 11,091,759
Issued: August 17, 2021
Inventor(s): Akinc; Akin et al.
Assignee(s): Genzyme Corporation (Cambridge, MA)The invention relates to iRNA, e.g., double stranded ribonucleic acid (dsRNA), compositions targeting the Serpinc1 gene, and methods of using such iRNA, e.g., dsRNA, compositions to inhibit expression of Serpinc1 and to treat subjects having a Serpinc1-associated disease, e.g., a bleeding disorder, such as a hemophilia.
Patent expiration dates:
- December 7, 2036✓
- December 7, 2036
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Serpinc1 iRNA compositions and methods of use thereof
Patent 9,127,274
Issued: September 8, 2015
Inventor(s): Akinc; Akin et al.
Assignee(s): Alnylam Pharmaceuticals, Inc. (Cambridge, MA)The invention relates to iRNA, e.g., double-stranded ribonucleic acid (dsRNA), compositions targeting the Serpinc1 gene, and methods of using such iRNA, e.g., dsRNA, compositions to inhibit expression of Serpinc1 and methods of treating subjects having a bleeding disorder, such as a hemophilia.
Patent expiration dates:
- March 22, 2033✓✓✓
- March 22, 2033
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Serpinc1 iRNA compositions and methods of use thereof
Patent 9,376,680
Issued: June 28, 2016
Inventor(s): Akinc; Akin et al.
Assignee(s): Alnylam Pharmaceuticals, Inc. (Cambridge, MA)The invention relates to iRNA, e.g., double-stranded ribonucleic acid (dsRNA), compositions targeting the Serpinc1 gene, and methods of using such iRNA, e.g., dsRNA, compositions to inhibit expression of Serpinc1 and methods of treating subjects having a bleeding disorder, such as a hemophilia.
Patent expiration dates:
- March 15, 2033✓✓✓
- March 15, 2033
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:
- March 28, 2030 - NEW CHEMICAL ENTITY
- March 28, 2032 - ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA B WITH OR WITHOUT FACTOR IX INHIBITORS
- March 28, 2032 - ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A WITH OR WITHOUT FACTOR VIII INHIBITORS
More about Qfitlia (fitusiran)
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- During pregnancy
- FDA approval history
- Drug class: miscellaneous coagulation modifiers
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Related/similar drugs
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.
