BAXFENDY Drug Patent Profile

When do Baxfendy patents expire, and what generic alternatives are available?

Baxfendy is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in thirty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Baxfendy

Baxfendy will be eligible for patent challenges on May 15, 2030. 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 February 4, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BAXFENDY

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	5
What excipients (inactive ingredients) are in BAXFENDY?	BAXFENDY excipients list
DailyMed Link:	BAXFENDY at DailyMed

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

NDA:

219878

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 BAXFENDY

BAXFENDY is protected by one US patents and one FDA Regulatory Exclusivity.

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
Astrazeneca Ab	BAXFENDY	baxdrostat	TABLET;ORAL	219878-001	May 15, 2026		RX	Yes	No			Y	Y
Astrazeneca Ab	BAXFENDY	baxdrostat	TABLET;ORAL	219878-002	May 15, 2026		RX	Yes	Yes
Astrazeneca Ab	BAXFENDY	baxdrostat	TABLET;ORAL	219878-001	May 15, 2026		RX	Yes	No
Astrazeneca Ab	BAXFENDY	baxdrostat	TABLET;ORAL	219878-002	May 15, 2026		RX	Yes	Yes			Y	Y

International Patents for BAXFENDY

When does loss-of-exclusivity occur for BAXFENDY?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 BAXFENDY around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	087984	DERIVADOS BICICLICOS DE DIHIDROQUINOLINA-2-ONA
Australia	2012311582	New bicyclic dihydroquinoline-2-one derivatives
Brazil	112014006660	novos derivados de dihidroquinolina-2-ona bicíclicos
Canada	2845170	NOUVEAUX DERIVES BICYCLIQUES DE DIHYDROQUINOLINE-2-ONE (NEW BICYCLIC DIHYDROQUINOLINE-2-ONE DERIVATIVES)
Chile	2014000663	Compuestos derivados de 2-oxo-1,2,3,4-tetrahidroquinolina, inhibidores de aldosterona sitasa (cyp11b2 o cyp11b1); proceso para prepararlos; composicion farmaceutica;metodo de tratamiento o profilaxis; y uso para el tratamiento o la profilaxis de una enfermedad renal cronica o fallo cardiaco congestivo, entre otras.
China	103827101	双环二氢喹啉-2-酮衍生物 (New bicyclic dihydroquinoline-2-one derivatives)