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Last Updated: November 4, 2024

FUROSEMIDE - Generic Drug Details


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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.

Drug Prices for FUROSEMIDE

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Drug Sales Revenue Trends for FUROSEMIDE

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Recent Clinical Trials for FUROSEMIDE

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

SponsorPhase
University of DelawareN/A
National Heart, Lung, and Blood Institute (NHLBI)N/A
University Hospital, ToursPhase 3

See all FUROSEMIDE clinical trials

Generic filers with tentative approvals for FUROSEMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up80MG PER 2.67MLINJECTABLE;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 ClassLoop Diuretic
Physiological EffectIncreased Diuresis at Loop of Henle
Medical Subject Heading (MeSH) Categories for FUROSEMIDE
Anatomical Therapeutic Chemical (ATC) Classes for FUROSEMIDE

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
Hikma FUROSEMIDE furosemide SOLUTION;ORAL 070433-001 Apr 22, 1987 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan FUROSEMIDE furosemide TABLET;ORAL 018487-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma FUROSEMIDE furosemide TABLET;ORAL 070086-001 Jan 24, 1986 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc FUROSEMIDE furosemide TABLET;ORAL 091258-003 Apr 1, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx FUROSEMIDE furosemide TABLET;ORAL 018413-002 Nov 30, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Marsam Pharms Llc FUROSEMIDE furosemide INJECTABLE;INJECTION 074017-001 Jun 30, 1994 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for FUROSEMIDE

Country Patent Number Title Estimated Expiration
South Korea 20210075211 퓨로세마이드의 피하 투여용 약학 제형 (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE) ⤷  Sign Up
European Patent Office 3799869 FORMULATIONS PHARMACEUTIQUES POUR L'ADMINISTRATION SOUS-CUTANÉE DE FUROSÉMIDE (PHARMACEUTICAL FORMULATIONS FOR SUBCUTANEOUS ADMINISTRATION OF FUROSEMIDE) ⤷  Sign Up
Spain 2823589 ⤷  Sign Up
Japan 2016515623 フロセミドの皮下投与用の医薬製剤 ⤷  Sign Up
Australia 2014248164 Pharmaceutical formulations for subcutaneous administration of furosemide ⤷  Sign Up
South Korea 102266460 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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