Fitusiran sodium - Generic Drug Details
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What are the generic drug sources for fitusiran sodium and what is the scope of freedom to operate?
Fitusiran sodium
is the generic ingredient in one branded drug marketed by Genzyme Corp and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for fitusiran sodium
| International Patents: | 101 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | fitusiran sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fitusiran sodium
Generic Entry Date for fitusiran sodium*:
Constraining patent/regulatory exclusivity:
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 Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for fitusiran sodium
| Drug Class | Antithrombin-directed RNA Interaction Small Interfering RNA |
| Physiological Effect | Decreased RNA Integrity Increased RNA Degradation |
Anatomical Therapeutic Chemical (ATC) Classes for fitusiran sodium
US Patents and Regulatory Information for fitusiran sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genzyme Corp | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-002 | Mar 28, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genzyme Corp | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-002 | Mar 28, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme Corp | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-001 | Mar 28, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genzyme Corp | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-001 | Mar 28, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genzyme Corp | QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019-001 | Mar 28, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for fitusiran sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2016368289 | ⤷ Start Trial | |
| Australia | 2023200828 | ⤷ Start Trial | |
| Australia | 2025201684 | ⤷ Start Trial | |
| Brazil | 112018011450 | ⤷ Start Trial | |
| Canada | 3007014 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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