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Generated: June 25, 2019

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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-two branded drugs marketed by Apil, Lupin Atlantis, Amneal Pharms, Chemo Research Sl, Glenmark Pharms Ltd, Mylan Labs Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs, Barr Labs Inc, Glenmark Generics, Apotex Inc, Vintage Pharms Llc, Glenmark Pharms, Barr, Mayne Pharma, and Parke Davis, and is included in sixty-five 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-two 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
Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.02MG;1MGTABLET, CHEWABLE;ORAL
➤ Sign Up➤ Sign Up0.01MG,0.01MG;1MG,N/ATABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Barr JUNEL FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076064-001 Sep 18, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mayne Pharma MICROGESTIN 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 075647-002 Jul 30, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms GILDESS 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 090293-001 Dec 1, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mayne Pharma MICROGESTIN FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 075647-001 Feb 5, 2001 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr JUNEL 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 076380-001 May 30, 2003 AB RX No No ➤ 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

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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 ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871-001 Feb 17, 2006 ➤ Sign Up ➤ Sign Up
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 ➤ Sign Up ➤ Sign Up
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 SZ 49/2008 Austria ➤ Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 93156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0771217 07C0001 France ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076 49/2008 Austria ➤ Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 15C0050 France ➤ Sign Up 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

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