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Last Updated: February 28, 2020

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Ethinyl estradiol; norelgestromin - Generic Drug Details

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

Ethinyl estradiol; norelgestromin is the generic ingredient in two branded drugs marketed by Janssen Pharms and Mylan Technologies, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norelgestromin. One supplier is listed for this compound.

Summary for ethinyl estradiol; norelgestromin
Recent Clinical Trials for ethinyl estradiol; norelgestromin

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

SponsorPhase
Janssen Research & Development, LLCPhase 4
Boston Medical CenterPhase 4
Janssen Research & Development, LLCPhase 1

See all ethinyl estradiol; norelgestromin clinical trials

Pharmacology for ethinyl estradiol; norelgestromin
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORELGESTROMIN
Tradename Dosage Ingredient NDA Submissiondate
ORTHO EVRA FILM, EXTENDED RELEASE;TRANSDERMAL ethinyl estradiol; norelgestromin 021180 2007-03-22

US Patents and Regulatory Information for ethinyl estradiol; norelgestromin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Technologies XULANE ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 200910-001 Apr 16, 2014 RX No Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 DISCN Yes 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; norelgestromin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001   Start Trial   Start Trial
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Medtronic
Colorcon
Dow
Mallinckrodt

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