LO MINASTRIN FE Drug Patent Profile
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When do Lo Minastrin Fe patents expire, 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
Summary for LO MINASTRIN FE
International Patents: | 9 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Patent Applications: | 166 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LO MINASTRIN FE |
DailyMed Link: | LO MINASTRIN FE at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for LO MINASTRIN FE
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 |
---|---|---|---|
Israel | 186656 | METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT | ⤷ Try a Trial |
Canada | 2605299 | REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) | ⤷ 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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LO MINASTRIN FE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
0136011 | 2000C/027 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1453521 | 15C0050 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |