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LO LOESTRIN FE Drug Profile

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Lo Loestrin Fe is a drug marketed by Apil and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

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. Sixteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for Tradename: LO LOESTRIN FE

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: LO LOESTRIN FE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 2010RXYes7,704,984<disabled> <disabled>
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Expired Patents for Tradename: LO LOESTRIN FE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 20105,552,394<disabled>
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International Patent Family for Tradename: LO LOESTRIN FE

Country Document Number Estimated Expiration
European Patent Office2305266<disabled in preview>
World Intellectual Property Organization (WIPO)2006115871<disabled in preview>
Israel186656<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LO LOESTRIN FE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0001France<disabled>PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
00C/027Belgium<disabled>PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1214076/01Switzerland<disabled>PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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