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Last Updated: March 29, 2024

LO MINASTRIN FE Drug Patent Profile


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When do Lo Minastrin Fe patents expire, and when can generic versions of Lo Minastrin Fe launch?

Lo Minastrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has nine patent family members in seven countries.

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

DrugPatentWatch® Generic Entry Outlook for Lo Minastrin Fe

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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

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US Patents and Regulatory Information for LO MINASTRIN FE

LO MINASTRIN FE is protected by one US patents.

Patents protecting LO MINASTRIN FE

Extended estrogen dosing contraceptive regimen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil LO MINASTRIN FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE, TABLET;ORAL 204654-001 Jul 24, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 MINASTRIN FE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil LO MINASTRIN FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE, TABLET;ORAL 204654-001 Jul 24, 2013 ⤷  Try a Trial ⤷  Try a Trial
Apil LO MINASTRIN FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE, TABLET;ORAL 204654-001 Jul 24, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LO MINASTRIN FE

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

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

Canada

Patent: 05299
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1189015
Estimated Expiration: ⤷  Try a Trial

Patent: 4248639
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 77062
Estimated Expiration: ⤷  Try a Trial

Patent: 05266
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 05468
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6656
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07013137
Estimated Expiration: ⤷  Try a Trial

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 MINASTRIN FE around the world.

Country Patent Number Title Estimated Expiration
Mexico 2007013137 REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.) ⤷  Try a Trial
Canada 2605299 REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) ⤷  Try a Trial
Israel 186656 METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LO MINASTRIN FE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 39/2015 Austria ⤷  Try a Trial 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 93156 Luxembourg ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.