➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Harvard Business School
Colorcon
Johnson and Johnson
Moodys

Last Updated: September 19, 2020

DrugPatentWatch Database Preview

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-four branded drugs marketed by Apil, Teva Pharms Usa Inc, Lupin Atlantis, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Xiromed, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs, Teva Branded Pharm, Barr Labs Inc, Glenmark Generics, Apotex, Vintage Pharms Llc, Glenmark Pharms, Barr, Mayne Pharma, and Parke Davis, and is included in sixty-seven NDAs. There are two 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. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Recent Clinical Trials for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
University of PennsylvaniaPhase 3

See all ETHINYL ESTRADIOL; NORETHINDRONE ACETATE clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.01MG,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.

Pharmacology for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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
Vintage Pharms GILDESS 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 090293-001 Dec 1, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Xiromed NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 209609-001 Jul 16, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202770-001 Feb 19, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Novast Labs LARIN FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 091453-001 Aug 23, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AUROVELA 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 207506-001 Jun 16, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076629-001 Mar 18, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
>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 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Moodys
Johnson and Johnson
Colorcon
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.