~ 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

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-seven 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?

Summary for LO LOESTRIN FE

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	7
Patent Applications:	130
Drug Prices:	Drug price information for LO LOESTRIN FE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO LOESTRIN FE
What excipients (inactive ingredients) are in LO LOESTRIN FE?	LO LOESTRIN FE excipients list
DailyMed Link:	LO LOESTRIN FE at DailyMed

Drug patent expirations by year for LO LOESTRIN FE

Recent Clinical Trials for LO LOESTRIN FE

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Eisai Inc.	Phase 1
Purdue Pharma LP	Phase 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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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

Expired US Patents for LO LOESTRIN FE

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
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
World Intellectual Property Organization (WIPO)	2006115871		⤷ Sign Up
China	101189015	Extended estrogen dosing contraceptive regimen	⤷ Sign Up
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LO LOESTRIN FE

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1214076	49/2008	Austria	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	93156	Luxembourg	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	15C0050	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0771217	CA 2006 00038	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description