ETHINYL ESTRADIOL AND NORELGESTROMIN Drug Patent Profile
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When do Ethinyl Estradiol And Norelgestromin patents expire, and when can generic versions of Ethinyl Estradiol And Norelgestromin launch?
Ethinyl Estradiol And Norelgestromin is a drug marketed by Amneal and Zydus Noveltech Inc and is included in two NDAs.
The generic ingredient in ETHINYL ESTRADIOL AND NORELGESTROMIN is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ethinyl Estradiol And Norelgestromin
A generic version of ETHINYL ESTRADIOL AND NORELGESTROMIN was approved as ethinyl estradiol; norelgestromin by AMNEAL on February 25th, 2021.
Summary for ETHINYL ESTRADIOL AND NORELGESTROMIN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 6 |
| Clinical Trials: | 20 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ETHINYL ESTRADIOL AND NORELGESTROMIN at DailyMed |
Recent Clinical Trials for ETHINYL ESTRADIOL AND 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 |
See all ETHINYL ESTRADIOL AND NORELGESTROMIN clinical trials
Pharmacology for ETHINYL ESTRADIOL AND NORELGESTROMIN
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL AND NORELGESTROMIN
US Patents and Regulatory Information for ETHINYL ESTRADIOL AND NORELGESTROMIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 213950-001 | Feb 25, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Noveltech Inc | ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 214594-001 | Sep 14, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ETHINYL ESTRADIOL AND 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 |
