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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Teva
AstraZeneca
McKinsey
UBS
Dow
Johnson and Johnson
Queensland Health
Argus Health

Generated: June 24, 2018

DrugPatentWatch Database Preview

Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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What are the generic drug 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-two 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, Parke Davis, and Glenmark Pharms, and is included in sixty-three 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.
Summary for ethinyl estradiol; norethindrone acetate
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, CHEWABLE;ORAL 210369-001 Dec 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 208639-001 Mar 21, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 RX Yes Yes ➤ 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 MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 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 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
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
C0001 France ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0814 Netherlands ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Cipla
Johnson and Johnson
Mallinckrodt
US Army
Colorcon
Accenture
Cerilliant
Boehringer Ingelheim

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