DrugPatentWatch Database Preview
QUARTETTE Drug Profile
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Which patents cover Quartette, and what generic alternatives are available?
Quartette is a drug marketed by Teva Branded Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-four patent family members in thirteen countries.
The generic ingredient in QUARTETTE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
US ANDA Litigation and Generic Entry Outlook for Quartette
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for QUARTETTE
| International Patents: | 24 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 2 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QUARTETTE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QUARTETTE |
| DailyMed Link: | QUARTETTE at DailyMed |
Paragraph IV (Patent) Challenges for QUARTETTE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| QUARTETTE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 204061 | 2013-07-10 |
US Patents and Regulatory Information for QUARTETTE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for QUARTETTE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2009004616 | Start Trial |
| Israel | 182287 | Start Trial |
| Brazil | PI0716291 | Start Trial |
| Mexico | 2007004120 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for QUARTETTE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 122015000093 | Germany | Start Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 0398460 | C300221 | Netherlands | Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1453521 | 39/2015 | Austria | Start 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 |
| 1214076 | C01214076/01 | Switzerland | Start Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
