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Ethinyl estradiol; norelgestromin - Generic Drug Details
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What are the generic 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
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 26 |
Suppliers / Packagers: | 1 |
Clinical Trials: | 18 |
DailyMed Link: | ethinyl estradiol; norelgestromin at DailyMed |
Recent Clinical Trials for ethinyl estradiol; norelgestromin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Research & Development, LLC | Phase 4 |
Boston Medical Center | Phase 4 |
Janssen Research & Development, LLC | Phase 1 |
Pharmacology for ethinyl estradiol; norelgestromin
Drug Class | Progestin Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
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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