NUVARING Drug Patent Profile
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When do Nuvaring patents expire, and what generic alternatives are available?
Nuvaring is a drug marketed by Organon Usa Organon and is included in one NDA.
The generic ingredient in NUVARING is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nuvaring
A generic version of NUVARING was approved as ethinyl estradiol; etonogestrel by TEVA PHARMS USA INC on January 13th, 2021.
Summary for NUVARING
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 28 |
| Patent Applications: | 169 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NUVARING |
| Drug Sales Revenues: | Drug sales revenues for NUVARING |
| What excipients (inactive ingredients) are in NUVARING? | NUVARING excipients list |
| DailyMed Link: | NUVARING at DailyMed |
Recent Clinical Trials for NUVARING
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lupin Research Inc | Phase 2 |
| Andrea Roe, MD, MPH | Phase 4 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 4 |
Pharmacology for NUVARING
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for NUVARING
Paragraph IV (Patent) Challenges for NUVARING
| 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 NUVARING
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organon Usa Organon | NUVARING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 021187-001 | Oct 3, 2001 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for NUVARING
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NUVARING
See the table below for patents covering NUVARING around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 6075198 | ⤷ Try a Trial | |
| Australia | 726934 | ⤷ Try a Trial | |
| Czech Republic | 294099 | ⤷ Try a Trial | |
| Israel | 123813 | DRUG DELIVERY SYSTEM FOR TWO OR MORE ACTIVE SUBSTANCES | ⤷ Try a Trial |
| Argentina | 011709 | UN SISTEMA DE APLICACION DE DROGAS, DE PREFERENCIA CON FORMA DE ANILLO, ADECUADO PARA LA ADMINISTRACION VAGINAL | ⤷ Try a Trial |
| China | 1163222 | ⤷ Try a Trial | |
| Hong Kong | 1016886 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NUVARING
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 1380301 | CA 2009 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 1453521 | 39/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0136011 | 2000C/027 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
| 1453521 | 93156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1214076 | 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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