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Last Updated: August 15, 2020

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ETHINYL ESTRADIOL; NORGESTIMATE - Generic Drug Details

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

Ethinyl estradiol; norgestimate is the generic ingredient in eighteen branded drugs marketed by Janssen Pharms, Xiromed, Aurobindo Pharma Ltd, Novast Labs Ltd, Amneal Pharms, Glenmark Generics, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan Labs Ltd, Naari Pte Ltd, Watson Labs, Vintage Pharms Llc, Barr, and Barr Labs Inc, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norgestimate. Eighteen suppliers are listed for this compound.

Recent Clinical Trials for ETHINYL ESTRADIOL; NORGESTIMATE

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

SponsorPhase
Benha UniversityPhase 2/Phase 3
Gilead SciencesPhase 1
Lexicon PharmaceuticalsPhase 1

See all ETHINYL ESTRADIOL; NORGESTIMATE clinical trials

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORGESTIMATE

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORGESTIMATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd TRI-LO-MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205762-001 Nov 4, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Naari Pte Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200383-001 Apr 7, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Xiromed TRI-LO-ESTARYLLA ethinyl estradiol; norgestimate TABLET;ORAL-28 091232-001 Jun 29, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Novast Labs Ltd TRI-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090524-001 May 30, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Barr SPRINTEC ethinyl estradiol; norgestimate TABLET;ORAL-28 075804-001 Sep 25, 2002 AB RX No Yes   Start Trial   Start Trial   Start Trial
Xiromed TRI-ESTARYLLA ethinyl estradiol; norgestimate TABLET;ORAL-28 090793-001 Jan 30, 2013 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; NORGESTIMATE

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Merck
Medtronic
McKesson
Dow

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