Furosemide - Generic Drug Details

What are the generic sources for furosemide and what is the scope of freedom to operate?

Furosemide is the generic ingredient in three branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Areva Pharms, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Meitheal, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wockhardt, Wyeth Ayerst, Sanofi Aventis Us, Pharmobedient Cnsltg, Scpharmaceuticals, Ani Pharms, Chartwell Rx, Epic Pharma Llc, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Mylan, Prinston Inc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs Teva, and Validus Pharms, and is included in sixty-nine NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Furosemide has twenty-four patent family members in fifteen countries.

There are twenty-two drug master file entries for furosemide. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for furosemide

International Patents:	24
US Patents:	3
Tradenames:	3
Applicants:	43
NDAs:	69
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	269
Patent Applications:	6,466
Drug Prices:	Drug price trends for furosemide
Drug Sales Revenues:	Drug sales revenues for furosemide
What excipients (inactive ingredients) are in furosemide?	furosemide excipients list
DailyMed Link:	furosemide at DailyMed

See drug prices for furosemide

See drug sales revenues for furosemide

Recent Clinical Trials for furosemide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Delaware	N/A
National Heart, Lung, and Blood Institute (NHLBI)	N/A
University Hospital, Tours	Phase 3

See all furosemide clinical trials

Generic filers with tentative approvals for FUROSEMIDE

Applicant	Application No.	Strength	Dosage Form
		80MG PER 2.67ML	INJECTABLE;SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for furosemide

Drug Class	Loop Diuretic
Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for furosemide

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for furosemide

C03CA	Sulfonamides, plain
C03C	HIGH-CEILING DIURETICS
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for furosemide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	FUROSEMIDE	furosemide	TABLET;ORAL	091258-002	Apr 1, 2014		DISCN	No	No
Hikma	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	018267-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
Hospira	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	072080-001	Aug 13, 1991		DISCN	No	No
Wockhardt	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	077941-001	Mar 22, 2007	AP	RX	No	No
Hikma	FUROSEMIDE	furosemide	SOLUTION;ORAL	070433-001	Apr 22, 1987		RX	No	No
Mankind Pharma	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	216860-001	Dec 16, 2022	AP	RX	No	No

Expired US Patents for furosemide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	LASIX	furosemide	INJECTABLE;INJECTION	016363-001	Approved Prior to Jan 1, 1982
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-002	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	LASIX	furosemide	SOLUTION;ORAL	017688-001	Approved Prior to Jan 1, 1982
Validus Pharms	LASIX	furosemide	TABLET;ORAL	016273-003	Approved Prior to Jan 1, 1982

International Patents for furosemide

Country	Patent Number	Title	Estimated Expiration
Spain	2823589
Israel	241917	פורמולציות למתן תת עורי של פורוסמיד (Pharmaceutical formulations for subcutaneous administration of furosemide)
South Korea	20160014592	퓨로세마이드의 피하 투여용 약학 제형 (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
European Patent Office	2981258	FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANÉE DE FUROSÉMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE)
Mexico	367165	FORMULACIONES FARMACÉUTICAS PARA ADMINISTRACIÓN SUBCUTÁNEA DE FUROSEMIDA. (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE.)
Singapore	11201508251R	PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE