QALSODY Drug Patent Profile
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When do Qalsody patents expire, and when can generic versions of Qalsody launch?
Qalsody is a drug marketed by Biogen Ma and is included in one NDA. There are three patents protecting this drug.
This drug has seventy-three patent family members in thirty countries.
The generic ingredient in QALSODY is tofersen. One supplier is listed for this compound. Additional details are available on the tofersen profile page.
DrugPatentWatch® Generic Entry Outlook for Qalsody
Qalsody will be eligible for patent challenges on April 25, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 1, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for QALSODY?
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Summary for QALSODY
| International Patents: | 73 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for QALSODY |
| What excipients (inactive ingredients) are in QALSODY? | QALSODY excipients list |
| DailyMed Link: | QALSODY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QALSODY
Generic Entry Date for QALSODY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRATHECAL |
*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.
Recent Clinical Trials for QALSODY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biogen | PHASE4 |
Pharmacology for QALSODY
| Drug Class | Antisense Oligonucleotide |
US Patents and Regulatory Information for QALSODY
QALSODY is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of QALSODY is ⤷ Start Trial.
This potential generic entry date is based on patent 10,385,341.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | 10,968,453 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Biogen Ma | QALSODY | tofersen | SOLUTION;INTRATHECAL | 215887-001 | Apr 25, 2023 | RX | Yes | Yes | 10,669,546 | ⤷ Start Trial | ⤷ 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 QALSODY
When does loss-of-exclusivity occur for QALSODY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15240761
Patent: Compositions for modulating SOD-1 expression
Estimated Expiration: ⤷ Start Trial
Patent: 19268063
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Patent: 22200002
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Patent: 24202423
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2016021848
Patent: COMPOSIÇÕES PARA MODULAÇÃO DE EXPRESSÃO DE SOD-1
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 42394
Patent: COMPOSITIONS MODULANT L'EXPRESSION DE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 50848
Estimated Expiration: ⤷ Start Trial
Chile
Patent: 16002509
Patent: Composiciones para modular la expresión de sod-1
Estimated Expiration: ⤷ Start Trial
Patent: 18001897
Patent: Composiciones para modular la expresión de sod-1 (divisional solicitud 201602509)
Estimated Expiration: ⤷ Start Trial
Patent: 19002535
Patent: Composiciones para modular la expresión de sod-1.(divisional solicitud 201801897).
Estimated Expiration: ⤷ Start Trial
China
Patent: 6459972
Patent: 用于调节SOD‑1表达的组合物 (Compositions for modulating SOD-1 expression)
Estimated Expiration: ⤷ Start Trial
Patent: 1440798
Patent: 用于调节SOD-1表达的组合物 (Compositions for modulating SOD-1 expression)
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0201078
Estimated Expiration: ⤷ Start Trial
Patent: 0220798
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 23288
Estimated Expiration: ⤷ Start Trial
Patent: 25507
Estimated Expiration: ⤷ Start Trial
Patent: 24029
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 26499
Estimated Expiration: ⤷ Start Trial
Patent: 57214
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 26499
Patent: COMPOSITIONS MODULANT L'EXPRESSION DE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 57214
Patent: COMPOSITIONS POUR MODULER L'EXPRESSION DE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 37573
Patent: COMPOSITIONS POUR MODULER L'EXPRESSION DE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Finland
Patent: 0240035
Estimated Expiration: ⤷ Start Trial
France
Patent: C1039
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 50704
Estimated Expiration: ⤷ Start Trial
Patent: 59109
Estimated Expiration: ⤷ Start Trial
Patent: 400035
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 7714
Patent: תכשירים למודולציה של ביטוי sod-1 (Compositions for modulating sod-1 expression)
Estimated Expiration: ⤷ Start Trial
Patent: 3404
Patent: תכשירים למודולציה של ביטוי sod-1 (Compositions for modulating sod-1 expression)
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 22214
Estimated Expiration: ⤷ Start Trial
Patent: 98298
Estimated Expiration: ⤷ Start Trial
Patent: 17513469
Patent: ＳＯＤ−１発現を調節するための組成物
Estimated Expiration: ⤷ Start Trial
Patent: 19201664
Patent: ＳＯＤ−１発現を調節するための組成物 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 21072840
Patent: ＳＯＤ−１発現を調節するための組成物 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 23027299
Patent: ＳＯＤ－１発現を調節するための組成物
Estimated Expiration: ⤷ Start Trial
Patent: 24105714
Patent: ＳＯＤ－１発現を調節するための組成物 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 26035746
Patent: ＳＯＤ－１発現を調節するための組成物
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 26499
Estimated Expiration: ⤷ Start Trial
Patent: 57214
Estimated Expiration: ⤷ Start Trial
Patent: 2024531
Estimated Expiration: ⤷ Start Trial
Luxembourg
Patent: 0359
Estimated Expiration: ⤷ Start Trial
Malaysia
Patent: 5665
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Patent: 2634
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 3908
Patent: COMPOSICIONES PARA MODULAR LA EXPRESION DE SOD-1. (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 16012922
Patent: COMPOSICIONES PARA MODULAR LA EXPRESION DE SOD-1. (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION.)
Estimated Expiration: ⤷ Start Trial
Patent: 20007166
Patent: COMPOSICIONES PARA MODULAR LA EXPRESION DE SOD-1. (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION.)
Estimated Expiration: ⤷ Start Trial
Netherlands
Patent: 1293
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 4100
Patent: Compositions for modulating sod-1 expression
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 26499
Estimated Expiration: ⤷ Start Trial
Patent: 57214
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 26499
Estimated Expiration: ⤷ Start Trial
Patent: 57214
Estimated Expiration: ⤷ Start Trial
Russian Federation
Patent: 04619
Patent: COMPOSITIONS FOR MODULATING EXPRESSION OF SOD-1
Estimated Expiration: ⤷ Start Trial
Patent: 16142532
Patent: КОМПОЗИЦИИ ДЛЯ МОДУЛИРОВАНИЯ ЭКСПРЕССИИ SOD-1 (COMPOSITIONS FOR MODULATING EXPRESSION OF SOD-1)
Estimated Expiration: ⤷ Start Trial
San Marino
Patent: 02000456
Estimated Expiration: ⤷ Start Trial
Patent: 02200479
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 707
Patent: KOMPOZICIJE ZA MODULACIJU EKSPRESIJE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 487
Patent: KOMPOZICIJE ZA MODULACIJU EKSPRESIJE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 201906520R
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Patent: 201910844S
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Patent: 201608109T
Patent: COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 26499
Estimated Expiration: ⤷ Start Trial
Patent: 57214
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2285629
Estimated Expiration: ⤷ Start Trial
Patent: 170012207
Patent: SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 210097225
Patent: SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 220077933
Patent: SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 230085222
Patent: SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 240111010
Patent: SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Patent: 250113519
Patent: SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 18236
Estimated Expiration: ⤷ Start Trial
Patent: 26869
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering QALSODY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2015240761 | ⤷ Start Trial | |
| Australia | 2019268063 | ⤷ Start Trial | |
| Australia | 2022200002 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QALSODY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3126499 | CR 2024 00038 | Denmark | ⤷ Start Trial | PRODUCT NAME: TOFERSEN; REG. NO/DATE: EU/1/23/1783 20240603 |
| 3126499 | 301293 | Netherlands | ⤷ Start Trial | PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 20240603 |
| 3126499 | LUC00359 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: TOFERSEN; AUTHORISATION NUMBER AND DATE: EU/1/23/1783 20240603 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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