Is there a generic for Losartan potassium?

Yes. The FDA Orange Book lists 25 approved generic (ANDA) applications for Losartan potassium, referencing the brand ARBLI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Losartan potassium?

ARBLI (NDA 218772, SCIENTURE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Losartan potassium?

The Orange Book lists 3 patents against Losartan potassium products, with the earliest listed expiry in 2041. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Losartan potassium are approved?

Losartan potassium is approved in the following dosage forms: suspension, tablet.

FDA Orange Book · active-ingredient family

Losartan potassium

Losartan potassium is approved as 2 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARBLI · NDA 218772

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension, tablet

Product	Applicant	Application	TE	Approved
ARBLIRLD	SCIENTURE	NDA 218772	—	Mar 13, 2025
COZAARRLD×3	ORGANON	NDA 020386	AB	Apr 14, 1995

Generic (ANDA) products (25)

Product	Applicant	Application	TE	Approved
LOSARTAN POTASSIUM×3	GRAVITI PHARMS	ANDA 219859	AB	Sep 19, 2025
LOSARTAN POTASSIUM×3	APOTEX	ANDA 218551	—	Jun 04, 2024
LOSARTAN POTASSIUM×3	MSN	ANDA 217396	AB	Aug 14, 2023
LOSARTAN POTASSIUM×3	GRANULES	ANDA 215959	AB	Feb 23, 2023
LOSARTAN POTASSIUM×3	HISUN PHARM HANGZHOU	ANDA 204795	—	Apr 04, 2019
LOSARTAN POTASSIUM×3	UNICHEM	ANDA 203030	AB	Oct 14, 2015
LOSARTAN POTASSIUM×3	HETERO LABS LTD V	ANDA 203835	AB	Aug 12, 2015
LOSARTAN POTASSIUM×3	IPCA LABS LTD	ANDA 200290	—	Aug 30, 2013
LOSARTAN POTASSIUM×3	MICRO LABS	ANDA 091541	AB	Sep 24, 2012
LOSARTAN POTASSIUM×3	JUBILANT CADISTA	ANDA 201170	AB	Sep 18, 2012
LOSARTAN POTASSIUM×3	MACLEODS PHARMS LTD	ANDA 202230	AB	May 30, 2012
LOSARTAN POTASSIUM×3	PRINSTON INC	ANDA 091497	AB	Jun 06, 2011
LOSARTAN POTASSIUM×3	AIPING PHARM INC	ANDA 090544	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	ALEMBIC PHARMS LTD	ANDA 090428	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	APOTEX CORP	ANDA 090790	—	Oct 06, 2010
LOSARTAN POTASSIUM×3	AUROBINDO PHARMA	ANDA 090083	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	CHARTWELL RX	ANDA 077424	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	HIKMA	ANDA 077459	—	Oct 06, 2010
LOSARTAN POTASSIUM×3	LUPIN LTD	ANDA 078232	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	MYLAN	ANDA 091590	—	Oct 06, 2010
LOSARTAN POTASSIUM×3	STRIDES PHARMA	ANDA 090382	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	TORRENT PHARMS	ANDA 090467	—	Oct 06, 2010
LOSARTAN POTASSIUM×3	WATSON LABS	ANDA 091129	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	ZYDUS PHARMS USA INC	ANDA 078243	AB	Oct 06, 2010
LOSARTAN POTASSIUM×3	TEVA	ANDA 076958	—	Apr 06, 2010

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12156869	Oct 07, 2041	in 15 yr 6 mo	ProductU-4158
12605365	Oct 07, 2041	in 15 yr 6 mo	ProductU-4159
11890273	Oct 07, 2041	in 15 yr 6 mo	Product

Losartan potassium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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