You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Merck
Baxter
McKesson
McKinsey

Last Updated: August 13, 2020

DrugPatentWatch Database Preview

ETHINYL ESTRADIOL; LEVONORGESTREL - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-two branded drugs marketed by Agile, Exeltis Usa Inc, Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Novast Labs, Sun Pharm, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, and Vintage Pharms Llc, and is included in seventy NDAs. There are sixteen patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has one hundred and sixty-one patent family members in thirty countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ETHINYL ESTRADIOL; LEVONORGESTREL
Recent Clinical Trials for ETHINYL ESTRADIOL; LEVONORGESTREL

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

SponsorPhase
Society of Family PlanningPhase 4
Oregon Health and Science UniversityPhase 4
Laboratorios Andromaco S.A.Phase 1

See all ETHINYL ESTRADIOL; LEVONORGESTREL clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL
  Start Trial  Start Trial0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,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; LEVONORGESTREL
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; LEVONORGESTREL
Tradename Dosage Ingredient NDA Submissiondate
QUARTETTE TABLET;ORAL ethinyl estradiol; levonorgestrel 204061 2013-07-10
LOSEASONIQUE TABLET;ORAL ethinyl estradiol; levonorgestrel 022262 2009-11-16
SEASONIQUE TABLET;ORAL ethinyl estradiol; levonorgestrel 021840 2008-01-22
LYBREL TABLET;ORAL ethinyl estradiol; levonorgestrel 021864 2007-10-05
SEASONALE TABLET;ORAL ethinyl estradiol; levonorgestrel 021544 2004-03-29

US Patents and Regulatory Information for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-21 075862-001 Apr 29, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm QUARTETTE ethinyl estradiol; levonorgestrel TABLET;ORAL 204061-001 Mar 28, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Cadence Health ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-21 020683-001 Mar 27, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glenmark Generics LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 202791-001 Apr 9, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Novast Labs SETLAKIN ethinyl estradiol; levonorgestrel TABLET;ORAL 090716-001 Sep 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Duramed Pharms Barr ENPRESSE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075809-002 Jul 16, 2001 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; LEVONORGESTREL

Supplementary Protection Certificates for ETHINYL ESTRADIOL; LEVONORGESTREL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 39/2015 Austria   Start 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
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
>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:

Dow
Medtronic
Colorcon
Johnson and Johnson
Harvard Business School
Mallinckrodt

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.