You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 10, 2024

~ Buy the LO LOESTRIN FE (ethinyl estradiol; norethindrone acetate) Drug Profile, 2024 PDF Report in the Report Store ~

LO LOESTRIN FE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Lo Loestrin Fe, and what generic alternatives are available?

Lo Loestrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in seven countries.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch® Generic Entry Outlook for Lo Loestrin Fe

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for LO LOESTRIN FE?
  • What are the global sales for LO LOESTRIN FE?
  • What is Average Wholesale Price for LO LOESTRIN FE?
Drug patent expirations by year for LO LOESTRIN FE
Drug Prices for LO LOESTRIN FE

See drug prices for LO LOESTRIN FE

Drug Sales Revenue Trends for LO LOESTRIN FE

See drug sales revenues for LO LOESTRIN FE

Recent Clinical Trials for LO LOESTRIN FE

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

SponsorPhase
Bristol-Myers SquibbPhase 1
Eisai Inc.Phase 1
Purdue Pharma LPPhase 1

See all LO LOESTRIN FE clinical trials

Paragraph IV (Patent) Challenges for LO LOESTRIN FE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LO LOESTRIN FE Tablets ethinyl estradiol; norethindrone acetate 1 mg/0.01 mg, 0.01 mg and 75 mg 022501 1 2011-04-29

US Patents and Regulatory Information for LO LOESTRIN FE

LO LOESTRIN FE is protected by one US patents.

Patents protecting LO LOESTRIN FE

Extended estrogen dosing contraceptive regimen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 RX Yes Yes ⤷  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

International Patents for LO LOESTRIN FE

When does loss-of-exclusivity occur for LO LOESTRIN FE?

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

Canada

Patent: 05299
Patent: REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1189015
Patent: Extended estrogen dosing contraceptive regimen
Estimated Expiration: ⤷  Sign Up

Patent: 4248639
Patent: Extended estrogen dosing contraceptive regimen
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 77062
Patent: REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Estimated Expiration: ⤷  Sign Up

Patent: 05266
Patent: Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 05468
Patent: 延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6656
Patent: METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07013137
Patent: REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)
Estimated Expiration: ⤷  Sign Up

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 LO LOESTRIN FE around the world.

Country Patent Number Title Estimated Expiration
China 101189015 Extended estrogen dosing contraceptive regimen ⤷  Sign Up
Israel 186656 METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006115871 ⤷  Sign Up
Hong Kong 1205468 延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) ⤷  Sign Up
China 104248639 Extended estrogen dosing contraceptive regimen ⤷  Sign Up
Mexico 2007013137 REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.) ⤷  Sign Up
European Patent Office 2305266 Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LO LOESTRIN FE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 C01214076/01 Switzerland ⤷  Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521 39/2015 Austria ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 300814 Netherlands ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217 07C0001 France ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301 CA 2009 00017 Denmark ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521 93156 Luxembourg ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.