➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Johnson and Johnson
Dow
Medtronic
Express Scripts

Last Updated: July 10, 2020

DrugPatentWatch Database Preview

ETHINYL ESTRADIOL; NORETHINDRONE - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

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

Ethinyl estradiol; norethindrone is the generic ingredient in one hundred and twelve branded drugs marketed by Apil, Lupin Ltd, Aurobindo Pharma Ltd, Accord Hlthcare, Amneal Pharms, Barr, Mylan Labs Ltd, Allergan, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Mayne Pharma, Glenmark Generics, Vintage Pharms, Vintage Pharms Llc, Novast Labs Ltd, Warner Chilcott Llc, Teva Pharms Usa Inc, Lupin Atlantis, Glenmark Pharms Ltd, Xiromed, Novast Labs, Teva Branded Pharm, Barr Labs Inc, Apotex, Glenmark Pharms, and Parke Davis, and is included in one hundred and forty-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ETHINYL ESTRADIOL; NORETHINDRONE

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

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

See all ETHINYL ESTRADIOL; NORETHINDRONE clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE
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
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORETHINDRONE
Tradename Dosage Ingredient NDA Submissiondate
ORTHO-NOVUM 7/7/7-28 TABLET;ORAL-28 ethinyl estradiol; norethindrone 018985
ORTHO-NOVUM 7/7/7-21 TABLET;ORAL-21 ethinyl estradiol; norethindrone 018985

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORETHINDRONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 076393-001 Feb 4, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202771-001 Nov 6, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AUROVELA 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 207581-001 Jun 26, 2017 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985-001 Apr 4, 1984   Start Trial   Start Trial
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490-001 Nov 14, 2003   Start Trial   Start Trial
Janssen Pharms ORTHO-NOVUM 7/7/7-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018985-002 Apr 4, 1984   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Johnson and Johnson
Dow
Medtronic
Express Scripts

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.