OJEMDA Drug Patent Profile

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Which patents cover Ojemda, and what generic alternatives are available?

Ojemda is a drug marketed by Day One Biopharms and is included in two NDAs. There are two patents protecting this drug.

This drug has forty-nine patent family members in twenty-seven countries.

The generic ingredient in OJEMDA is tovorafenib. One supplier is listed for this compound. Additional details are available on the tovorafenib profile page.

DrugPatentWatch^® Generic Entry Outlook for Ojemda

Ojemda will be eligible for patent challenges on April 23, 2028. 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 23, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OJEMDA

International Patents:	49
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Applications:	79
What excipients (inactive ingredients) are in OJEMDA?	OJEMDA excipients list
DailyMed Link:	OJEMDA at DailyMed

Drug patent expirations by year for OJEMDA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OJEMDA

Generic Entry Dates for OJEMDA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION NDA: 218033 Dosage: FOR SUSPENSION;ORAL
Generic Entry Dates for OJEMDA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION NDA: 217700 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.

US Patents and Regulatory Information for OJEMDA

OJEMDA is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OJEMDA is ⤷ Subscribe.

This potential generic entry date is based on TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OJEMDA

Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe

Compounds useful as Raf kinase inhibitors
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe

FDA Regulatory Exclusivity protecting OJEMDA

TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION
Exclusivity Expiration: ⤷ Subscribe

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Subscribe

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Day One Biopharms	OJEMDA	tovorafenib	FOR SUSPENSION;ORAL	218033-001	Apr 23, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Day One Biopharms	OJEMDA	tovorafenib	TABLET;ORAL	217700-001	Apr 23, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Day One Biopharms	OJEMDA	tovorafenib	FOR SUSPENSION;ORAL	218033-001	Apr 23, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Day One Biopharms	OJEMDA	tovorafenib	TABLET;ORAL	217700-001	Apr 23, 2024		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 OJEMDA

When does loss-of-exclusivity occur for OJEMDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7354
Patent: COMPUESTOS UTILES COMO INHIBIDORES DE LA RAF QUINASA
Estimated Expiration: ⤷ Subscribe

Australia

Patent: 08273002
Patent: Pyrimidine derivatives useful as Raf kinase inhibitors
Estimated Expiration: ⤷ Subscribe

Brazil

Patent: 0813499
Patent: COMPOSTOS ÚTEIS COMO INIBIDORES DA QUINASE RAF
Estimated Expiration: ⤷ Subscribe

Canada

Patent: 93182
Patent: COMPOSES UTILES EN TANT QU'INHIBITEURS DE LA KINASE RAF (COMPOUNDS USEFUL AS RAF KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe

Chile

Patent: 08001933
Patent: Compuestos derivados de pirimidina, inhibidores de la raf quinasa; compuestos intermediarios; procedimiento de preparacion; composicion farmaceutica; y su uso para tratar trastornos proliferativos, cardiacos, neurodegenerativos, inflamatorios, oseos, inmunologicos enfermedad viral, entre otros.
Estimated Expiration: ⤷ Subscribe

China

Patent: 1784545
Patent: Compounds useful as raf kinase inhibitors
Estimated Expiration: ⤷ Subscribe

Patent: 4370828
Patent: COMPOUNDS USEFUL AS RAF KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe

Patent: 6957314
Patent: 用作RAF激酶抑制剂的嘧啶衍生物 (Compounds useful as Raf kinase inhibitors)
Estimated Expiration: ⤷ Subscribe

Denmark

Patent: 31798
Estimated Expiration: ⤷ Subscribe

European Patent Office

Patent: 67489
Patent: COMPOSÉS UTILES EN TANT QU'INHIBITEURS DE LA KINASE RAF (PYRIMIDINE DERIVATIVES USEFUL AS RAF KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe

Patent: 31798
Patent: DÉRIVÉS DE THIAZOLE UTILES DANS LA PRÉPARATION DES INHIBITEURS DE LA KINASE RAF (THIAZOLE INTERMEDIATES USEFUL IN THE PREPARATION OF RAF KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe

Israel

Patent: 2835
Patent: נגזרות פירימידין,הרכבים רוקחיים שלהם, תהליך להכנתם ושימושיהם כמעכבי raf קינאז (Pyrimidine derivatives , pharmaceutical compositions thereof, process for their manufacture and uses thereof as raf kinase inhibitors)
Estimated Expiration: ⤷ Subscribe

Japan

Patent: 49445
Estimated Expiration: ⤷ Subscribe

Patent: 62622
Estimated Expiration: ⤷ Subscribe

Patent: 10532380
Estimated Expiration: ⤷ Subscribe

Patent: 13256534
Patent: COMPOUNDS USEFUL AS RAF KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe

Patent: 15117249
Patent: ＲＡＦキナーゼ阻害剤として有用な化合物 (COMPOUND USEFUL AS RAF KINASE INHIBITOR)
Estimated Expiration: ⤷ Subscribe

New Zealand

Patent: 2352
Patent: PYRIMIDINE DERIVATIVES USEFUL AS RAF KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe

Russian Federation

Patent: 92166
Patent: СОЕДИНЕНИЯ, ПОДХОДЯЩИЕ ДЛЯ ПРИМЕНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ RAF (COMPOUNDS SUITABLE FOR USE AS RAF KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe

Patent: 09149214
Patent: СОЕДИНЕНИЯ, ПОДХОДЯЩИЕ ДЛЯ ПРИМЕНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ RAF
Estimated Expiration: ⤷ Subscribe

South Africa

Patent: 0909223
Patent: PYRIMIDINE DERIVATIVES USEFUL AS RAF KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe

South Korea

Patent: 1650140
Estimated Expiration: ⤷ Subscribe

Patent: 1764076
Estimated Expiration: ⤷ Subscribe

Patent: 100033384
Patent: PYRIMIDINE DERIVATIVES USEFUL AS RAF KINASE INHIBITORS
Estimated Expiration: ⤷ Subscribe

Patent: 160027992
Patent: ＲＡＦ 카나아제 억제제로서 유용한 화합물 (PYRIMIDINE DERIVATIVES USEFUL AS RAF KINASE INHIBITORS)
Estimated Expiration: ⤷ Subscribe

Spain

Patent: 35729
Estimated Expiration: ⤷ Subscribe

Patent: 76169
Estimated Expiration: ⤷ Subscribe

Taiwan

Patent: 44379
Estimated Expiration: ⤷ Subscribe

Patent: 0916467
Patent: Compounds useful as Raf kinase inhibitors
Estimated Expiration: ⤷ Subscribe

Ukraine

Patent: 1478
Patent: СОЕДИНЕНИЯ, ПОЛЕЗНЫЕ КАК ИНГИБИТОРЫ RAF-КИНАЗЫ;СПОЛУКИ, КОРИСНІ ЯК ІНГІБІТОРИ Raf-КІНАЗИ (COMPOUNDS USEFUL AS INHIBITORS OF RAF PROTEIN KINASE)
Estimated Expiration: ⤷ Subscribe

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 OJEMDA around the world.

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Country	Patent Number	Title	Estimated Expiration
Costa Rica	20160483	FORMULACIONES FARMACÉUTICAS, PROCESOS PARA LA PREPARACIÓN Y MÉTODOS DE USO	⤷ Subscribe
Dominican Republic	P2016000254	FORMULACIONES FARMECEUTICAS DE INHIBIDOR DE LA QUINASA PAN-RAF, PROCEDIMIENTOS PARA SU PREPARACION, Y METODOS DE USO.	⤷ Subscribe
Colombia	2016003340	Formulaciones farmacéuticas, procesos para la preparación y métodos de uso	⤷ Subscribe
South Korea	101764076		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration