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Last Updated: March 19, 2024

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

Twenty 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
AmgenPhase 1
Gilead SciencesPhase 1

See all ETHINYL ESTRADIOL; NORGESTIMATE clinical trials

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
Barr Labs Inc TRI LO SPRINTEC ethinyl estradiol; norgestimate TABLET;ORAL-28 076784-001 Jun 29, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200538-001 Apr 5, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200494-001 Jun 17, 2011 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 076626-001 Aug 17, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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