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Generated: May 21, 2018

DrugPatentWatch Database Preview

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - Generic Drug Details

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What are the generic sources for ethinyl estradiol; norethindrone acetate and what is the scope of ethinyl estradiol; norethindrone acetate freedom to operate?

Ethinyl estradiol; norethindrone acetate
is the generic ingredient in fifty branded drugs marketed by Apil, Lupin Atlantis, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs Ltd, Barr Labs Inc, Glenmark Generics, Apotex Inc, Vintage Pharms Llc, Barr, Mayne Pharma, and Parke Davis, and is included in sixty-one NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norethindrone acetate has forty patent family members in twenty-four countries.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone acetate. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.02MG;1MGTABLET, CHEWABLE;ORAL
➤ Try a Free Trial➤ Try a Free Trial0.01MG,0.01MG;1MG,N/ATABLET;ORAL

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 204847-001 Nov 17, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amneal Pharms NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 078267-001 Sep 1, 2009 AB RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Ltd BLISOVI FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 201585-001 Nov 18, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Parke Davis NORLESTRIN 28 1/50 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 016723-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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 ➤ Try a Free Trial ➤ Try a Free Trial
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-002 Oct 15, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
00C/027 Belgium ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2009 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
Baxter
Medtronic
QuintilesIMS
Mallinckrodt
Boehringer Ingelheim
Julphar
Chubb

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