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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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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.
ISSN: 2162-2639
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