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Last Updated: March 28, 2024

LO MINASTRIN FE Drug Patent Profile


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

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
European Patent Office 2305266 Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen) ⤷  Try a Trial
China 101189015 Extended estrogen dosing contraceptive regimen ⤷  Try a Trial
European Patent Office 1877062 REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) ⤷  Try a Trial
Israel 186656 METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT ⤷  Try a Trial
Hong Kong 1205468 延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) ⤷  Try a Trial
China 104248639 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LO MINASTRIN FE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076 C01214076/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0398460 C300221 Netherlands ⤷  Try a Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 122015000093 Germany ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
>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.