ETHINYL ESTRADIOL; ETONOGESTREL - Generic Drug Details
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What are the generic drug sources for ethinyl estradiol; etonogestrel and what is the scope of freedom to operate?
Ethinyl estradiol; etonogestrel
is the generic ingredient in six branded drugs marketed by Amneal, Xiromed, Teva Pharms Usa Inc, Dr Reddys Labs Sa, and Organon Usa Organon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.Ten suppliers are listed for this compound.
Summary for ETHINYL ESTRADIOL; ETONOGESTREL
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 5 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 10 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157-001 | Jun 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Sa | VERARING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 207577-001 | Dec 9, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | |||
| Amneal | ELURYNG | ethinyl estradiol; etonogestrel | RING;VAGINAL | 210830-001 | Dec 11, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon Usa Organon | NUVARING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 021187-001 | Oct 3, 2001 | AB | RX | Yes | Yes | ⤷ 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; ETONOGESTREL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Organon | NUVARING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 021187-001 | Oct 3, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >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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