RHAPSIDO Drug Patent Profile
When do Rhapsido patents expire, and what generic alternatives are available?
Rhapsido is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.
The generic ingredient in RHAPSIDO is remibrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the remibrutinib profile page.
DrugPatentWatch® Generic Entry Outlook for Rhapsido
Rhapsido will be eligible for patent challenges on September 30, 2029. 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 November 13, 2034. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for RHAPSIDO?
- What are the global sales for RHAPSIDO?
- What is Average Wholesale Price for RHAPSIDO?
Summary for RHAPSIDO
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for RHAPSIDO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RHAPSIDO |
| What excipients (inactive ingredients) are in RHAPSIDO? | RHAPSIDO excipients list |
| DailyMed Link: | RHAPSIDO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RHAPSIDO
Generic Entry Date for RHAPSIDO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 RHAPSIDO
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Bruton's Tyrosine Kinase Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for RHAPSIDO
RHAPSIDO is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RHAPSIDO is ⤷ Start Trial.
This potential generic entry date is based on patent 9,512,084.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | RHAPSIDO | remibrutinib | TABLET;ORAL | 218436-001 | Sep 30, 2025 | RX | Yes | Yes | 10,457,647 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novartis | RHAPSIDO | remibrutinib | TABLET;ORAL | 218436-001 | Sep 30, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novartis | RHAPSIDO | remibrutinib | TABLET;ORAL | 218436-001 | Sep 30, 2025 | RX | Yes | Yes | 12,419,889 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novartis | RHAPSIDO | remibrutinib | TABLET;ORAL | 218436-001 | Sep 30, 2025 | RX | Yes | Yes | 9,512,084 | ⤷ 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 RHAPSIDO
When does loss-of-exclusivity occur for RHAPSIDO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8549
Patent: DERIVADOS DE AMINO PIRIMIDINA
Estimated Expiration: ⤷ Start Trial
Australia
Patent: 14356069
Patent: Novel amino pyrimidine derivatives
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2016010397
Patent: derivados de amino pirimidina, seus usos, e composição e combinação farmacêuticas
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 26908
Patent: DERIVES DE PYRIMIDINE AMINEE (AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Chile
Patent: 16001055
Patent: Compuestos derivados de fenil-aminopirimidina, inhibidores de la tirosina quinasa de bruton (btk), composicion farmaceutica; combinacion farmaceutica; útiles en el tratamiento de enfermedades autoinmunes, inflamatorias, alergicas, de las vias aereas, entre otras.
Estimated Expiration: ⤷ Start Trial
China
Patent: 5683181
Patent: 新的氨基嘧啶衍生物 (Novel amino pyrimidine derivatives)
Estimated Expiration: ⤷ Start Trial
Patent: 0172056
Patent: 新的氨基嘧啶衍生物 (Novel amino pyrimidine derivatives)
Estimated Expiration: ⤷ Start Trial
Costa Rica
Patent: 160244
Patent: Derivados Novedosos de Amino Pirimidina
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0171999
Estimated Expiration: ⤷ Start Trial
Patent: 0200775
Estimated Expiration: ⤷ Start Trial
Patent: 0230585
Estimated Expiration: ⤷ Start Trial
Cuba
Patent: 384
Patent: DERIVADOS DE N-(3-(6-AMINOPIRIDIN-4-IL)FENIL)BENZAMIDA COMO INHIBIDORES DE BTK
Estimated Expiration: ⤷ Start Trial
Patent: 160078
Patent: DERIVADOS DE N-(3-(6-AMINOPIRIDIN-4-IL)FENIL)BENZAMIDA COMO INHIBIDORES DE BTK
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 19705
Estimated Expiration: ⤷ Start Trial
Patent: 22924
Estimated Expiration: ⤷ Start Trial
Patent: 26056
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 74386
Estimated Expiration: ⤷ Start Trial
Patent: 99368
Estimated Expiration: ⤷ Start Trial
Patent: 89865
Estimated Expiration: ⤷ Start Trial
Ecuador
Patent: 16054826
Patent: Derivados Novedosos de Amino Pirimidina
Estimated Expiration: ⤷ Start Trial
El Salvador
Patent: 16005206
Patent: DERIVADOS NOVEDOSOS DE AMINO PIRIMIDINA
Estimated Expiration: ⤷ Start Trial
Eurasian Patent Organization
Patent: 1218
Patent: НОВЫЕ ПРОИЗВОДНЫЕ АМИНОПИРИМИДИНА (AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 1691125
Patent: ПРОИЗВОДНЫЕ АМИНОПИРИМИДИНА (AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 74386
Patent: NOUVEAUX DERIVÉS D'AMINO PYRIMIDINES (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 99368
Patent: NOUVEAUX DÉRIVÉS D'AMINO PYRIMIDINE (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 89865
Patent: NOUVEAUX DÉRIVÉS D'AMINO PYRIMIDINE (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 19478
Patent: MÉTHODE DE PREPARATION DE DÉRIVÉS D'AMINO PYRIMIDINE (METHOD OF PREPARING AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 06377
Patent: NOUVEAUX DERIVÉS D'AMINO PYRIMIDINES (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Finland
Patent: 89865
Estimated Expiration: ⤷ Start Trial
Patent: 0265019
Estimated Expiration: ⤷ Start Trial
Hong Kong
Patent: 23368
Patent: 新式氨基嘧啶衍生物 (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 52317
Patent: 新的氨基嘧啶衍生物 (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 37588
Estimated Expiration: ⤷ Start Trial
Patent: 49794
Estimated Expiration: ⤷ Start Trial
Patent: 62248
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 4943
Patent: תולדות n–[3–(5– אוקסי–6–אמינו–פירימידינ–4–יל)פניל]בנזאמיד ותכשירים רוקחיים הכוללים אותן (N-[3-(5-oxy-6-amino-pyrimidin-4-yl)phenyl]benzamide derivatives and pharmaceutical compositions comprising them)
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 42495
Estimated Expiration: ⤷ Start Trial
Patent: 67573
Estimated Expiration: ⤷ Start Trial
Patent: 16538313
Patent: 新規なアミノピリミジン誘導体
Estimated Expiration: ⤷ Start Trial
Patent: 18141005
Patent: 新規なアミノピリミジン誘導体 (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Jordan
Patent: 14
Patent: مشتقات أمينو بيريميدين جديدة (Novel Amino Pyrimidine Derivatives)
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 74386
Estimated Expiration: ⤷ Start Trial
Patent: 99368
Estimated Expiration: ⤷ Start Trial
Patent: 89865
Estimated Expiration: ⤷ Start Trial
Patent: 2026528
Estimated Expiration: ⤷ Start Trial
Malaysia
Patent: 9059
Patent: NOVEL AMINO PYRIMIDINE DERIVATIVES
Estimated Expiration: ⤷ Start Trial
Patent: 1381
Patent: NOVEL AMINO PYRIMIDINE DERIVATIVES
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 7911
Patent: DERIVADOS NOVEDOSOS DE AMINO PIRIMIDINA. (NOVEL AMINO PYRIMIDINE DERIVATIVES.)
Estimated Expiration: ⤷ Start Trial
Patent: 16006908
Patent: DERIVADOS NOVEDOSOS DE AMINO PIRIMIDINA. (NOVEL AMINO PYRIMIDINE DERIVATIVES.)
Estimated Expiration: ⤷ Start Trial
Morocco
Patent: 055
Patent: Nouveaux dérivés d'aminopyrimidine
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 8835
Patent: Novel amino pyrimidine derivatives
Estimated Expiration: ⤷ Start Trial
Norway
Patent: 26036
Estimated Expiration: ⤷ Start Trial
Patent: 74386
Estimated Expiration: ⤷ Start Trial
Peru
Patent: 160869
Patent: DERIVADOS NOVEDOSOS DE AMINO PIRIMIDINA
Estimated Expiration: ⤷ Start Trial
Philippines
Patent: 016500791
Patent: NOVEL AMINO PYRIMIDINE DERIVATIVES
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 74386
Estimated Expiration: ⤷ Start Trial
Patent: 99368
Estimated Expiration: ⤷ Start Trial
Patent: 89865
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 74386
Estimated Expiration: ⤷ Start Trial
Patent: 99368
Estimated Expiration: ⤷ Start Trial
Patent: 89865
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 657
Patent: NOVI DERIVATI AMINO PIRIMIDINA (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 251
Patent: NOVI DERIVATI AMINOPIRIMIDINA (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 275
Patent: NOVI DERIVATI AMINOPIRIMIDINA (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 74386
Estimated Expiration: ⤷ Start Trial
Patent: 99368
Estimated Expiration: ⤷ Start Trial
Patent: 89865
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 1602275
Patent: NOVEL AMINO PYRIMIDINE DERIVATIVES
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2380539
Estimated Expiration: ⤷ Start Trial
Patent: 2421388
Estimated Expiration: ⤷ Start Trial
Patent: 160088877
Patent: 신규 아미노 피리미딘 유도체 (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Patent: 220044370
Patent: 신규 아미노 피리미딘 유도체 (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 55527
Estimated Expiration: ⤷ Start Trial
Patent: 91525
Estimated Expiration: ⤷ Start Trial
Patent: 47770
Estimated Expiration: ⤷ Start Trial
Patent: 40769
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 1609666
Patent: Novel amino pyrimidine derivatives
Estimated Expiration: ⤷ Start Trial
Patent: 52261
Estimated Expiration: ⤷ Start Trial
Tunisia
Patent: 16000128
Patent: NOVEL AMINO PYRIMIDINE DERIVATIVES.
Estimated Expiration: ⤷ Start Trial
Ukraine
Patent: 7256
Patent: ПОХІДНІ АМІНОПІРИМІДИНУ (NOVEL AMINO PYRIMIDINE DERIVATIVES)
Estimated Expiration: ⤷ Start Trial
Uruguay
Patent: 858
Patent: NUEVOS DERIVADOS DE AMINO PIRIMIDINA
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 RHAPSIDO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 098549 | ⤷ Start Trial | |
| Australia | 2014356069 | ⤷ Start Trial | |
| Brazil | 112016010397 | ⤷ Start Trial | |
| Canada | 2926908 | ⤷ Start Trial | |
| Chile | 2016001055 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RHAPSIDO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3299368 | C20265019 | Finland | ⤷ Start Trial | |
| 3299368 | CA 2026 00037 | Denmark | ⤷ Start Trial | PRODUCT NAME: REMIBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/26/2024 20260424 |
| 3299368 | PA2026528 | Lithuania | ⤷ Start Trial | PRODUCT NAME: REMIBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/26/2024 20260423 |
| 3299368 | LUC50061 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: REMIBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/26/2024 20260424 |
| 3299368 | 301397 | Netherlands | ⤷ Start Trial | PRODUCT NAME: REMIBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/26/2024 20260424 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for RHAPSIDO
Make Better Decisions: Try a trial or see plans & pricing
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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