LO LOESTRIN FE Drug Patent Profile
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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
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Questions you can ask:
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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 |
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 |
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 |
Expired US Patents for LO LOESTRIN FE
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.
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 |