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 four branded drugs marketed by Amneal, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, and Mylan Technologies, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.Eight suppliers are listed for this compound.
Summary for ETHINYL ESTRADIOL; NORELGESTROMIN
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 8 |
| Clinical Trials: | 20 |
| DailyMed Link: | ETHINYL ESTRADIOL; NORELGESTROMIN at DailyMed |
Recent Clinical Trials for ETHINYL ESTRADIOL; NORELGESTROMIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mylan Inc. | Phase 3 |
| Mylan Technologies Inc. | Phase 3 |
| Janssen Research & Development, LLC | Phase 4 |
Pharmacology for ETHINYL ESTRADIOL; NORELGESTROMIN
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; NORELGESTROMIN
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORELGESTROMIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ORTHO EVRA | Transdermal System | ethinyl estradiol; norelgestromin | 0.15 mg/0.02 mg per 24 hours | 021180 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | ONSURA | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 213977-001 | Aug 25, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Technologies | XULANE | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 200910-001 | Apr 16, 2014 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Noveltech Inc | ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 214594-001 | Sep 14, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | ORTHO EVRA | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021180-001 | Nov 20, 2001 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 213950-001 | Feb 25, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO EVRA | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021180-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ETHINYL ESTRADIOL; NORELGESTROMIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Gedeon Richter Plc. | Evra | norelgestromin, ethinyl estradiol | EMEA/H/C/000410 Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years. |
Authorised | no | no | no | 2002-08-22 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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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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