QUARTETTE Drug Patent 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-three 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. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
DrugPatentWatch® 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: | 23 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Patent Applications: | 339 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for QUARTETTE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QUARTETTE |
What excipients (inactive ingredients) are in QUARTETTE? | QUARTETTE excipients list |
DailyMed Link: | QUARTETTE at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for QUARTETTE
Paragraph IV (Patent) Challenges for QUARTETTE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
QUARTETTE | Tablets | ethinyl estradiol; levonorgestrel | 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg | 204061 | 1 | 2013-07-10 |
US Patents and Regulatory Information for QUARTETTE
QUARTETTE is protected by two US patents.
Patents protecting QUARTETTE
Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Branded Pharm | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for QUARTETTE
When does loss-of-exclusivity occur for QUARTETTE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1931
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 05294269
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0516247
Estimated Expiration: ⤷ Try a Trial
Patent: 0716291
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 82530
Estimated Expiration: ⤷ Try a Trial
Patent: 68211
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1068552
Estimated Expiration: ⤷ Try a Trial
Patent: 1626760
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 14556
Estimated Expiration: ⤷ Try a Trial
Patent: 79461
Estimated Expiration: ⤷ Try a Trial
Patent: 92332
Estimated Expiration: ⤷ Try a Trial
Patent: 92333
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8441
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 08515909
Estimated Expiration: ⤷ Try a Trial
Patent: 10508275
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07004120
Estimated Expiration: ⤷ Try a Trial
Patent: 09004616
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 09120528
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 090094437
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 0626161
Estimated Expiration: ⤷ Try a Trial
Patent: 0831107
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering QUARTETTE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200626161 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens | ⤷ Try a Trial |
South Korea | 20090094437 | METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS | ⤷ Try a Trial |
European Patent Office | 2392332 | Procédé de traitement hormonal utilisant des régimes de cycle étendu à dose croissante (Methods of hormonal treatment utilizing ascending-dose extended cycle regimens) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QUARTETTE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |