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Last Updated: July 8, 2020

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Estradiol; norgestimate - Generic Drug Details

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

Estradiol; norgestimate is the generic ingredient in two branded drugs marketed by Barr and Teva Womens, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; norgestimate has eighteen patent family members in sixteen countries.

There are seventy-five drug master file entries for estradiol; norgestimate. One supplier is listed for this compound.

Summary for estradiol; norgestimate
International Patents:18
US Patents:2
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 75
Suppliers / Packagers: 1
Clinical Trials: 28
DailyMed Link:estradiol; norgestimate at DailyMed
Recent Clinical Trials for estradiol; norgestimate

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

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

See all estradiol; norgestimate clinical trials

Paragraph IV (Patent) Challenges for ESTRADIOL; NORGESTIMATE
Tradename Dosage Ingredient NDA Submissiondate
PREFEST TABLET;ORAL estradiol; norgestimate 021040

US Patents and Regulatory Information for estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 DISCN Yes No   Start Trial   Start Trial   Start Trial
Barr ESTRADIOL AND NORGESTIMATE estradiol; norgestimate TABLET;ORAL 076812-001 Apr 29, 2005 RX No Yes   Start Trial   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 DISCN Yes No   Start Trial   Start Trial Y   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 estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for estradiol; norgestimate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 97C0002 Belgium   Start Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 C201630040 Spain   Start Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Colorcon
McKesson
Johnson and Johnson
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.