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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 drug 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

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
>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:

Express Scripts
Boehringer Ingelheim

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.