ETHINYL ESTRADIOL; ETONOGESTREL Drug Patent Profile
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Which patents cover Ethinyl Estradiol; Etonogestrel, and what generic alternatives are available?
Ethinyl Estradiol; Etonogestrel is a drug marketed by Teva Pharms Usa Inc and is included in one NDA.
The generic ingredient in ETHINYL ESTRADIOL; ETONOGESTREL is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ethinyl Estradiol; Etonogestrel
A generic version of ETHINYL ESTRADIOL; ETONOGESTREL was approved as ethinyl estradiol; etonogestrel by TEVA PHARMS USA INC on January 13th, 2021.
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Summary for ETHINYL ESTRADIOL; ETONOGESTREL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 12 |
| DailyMed Link: | ETHINYL ESTRADIOL; ETONOGESTREL at DailyMed |
Recent Clinical Trials for ETHINYL ESTRADIOL; ETONOGESTREL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lupin Research Inc | Phase 2 |
| University of Washington | Phase 1 |
| Wits Reproductive Health and HIV Institute | Phase 1 |
Pharmacology for ETHINYL ESTRADIOL; ETONOGESTREL
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; ETONOGESTREL
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; ETONOGESTREL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NUVARING | Vaginal Ring | ethinyl estradiol; etonogestrel | 0.015 mg/24 hour 0.12 mg/24 hour | 021187 | 1 | 2013-06-17 |
US Patents and Regulatory Information for ETHINYL ESTRADIOL; ETONOGESTREL
| 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 Inc | ETHINYL ESTRADIOL; ETONOGESTREL | ethinyl estradiol; etonogestrel | RING;VAGINAL | 204305-001 | Jan 13, 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 |
