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Last Updated: November 2, 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 Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte Ltd, Watson Labs, Endo Operations, 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-two 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
Lupin Pharms NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200541-001 Jun 25, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Naari Pte Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200383-001 Apr 7, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma TRI-LO-MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205762-001 Nov 4, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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-21 019697-002 Jul 3, 1992 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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