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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for QUARTETTE?
- What are the global sales for QUARTETTE?
- What is Average Wholesale Price for QUARTETTE?
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: | 277 |
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 |
![QUARTETTE drug patent expirations Drug patent expirations by year for QUARTETTE](/p/graph/s/t/QUARTETTE-patent-expirations.png)
![Drug Prices for QUARTETTE](/p/graph/drug-price/QUARTETTE.png)
![Drug Sales Revenue Trends for QUARTETTE](/p/graph/drug-sales-revenues/QUARTETTE.png)
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Branded Pharm | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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
Patent: METODOS DE TRATAMIENTO HORMONAL QUE UTILIZAN REGIMENES DE CICLOS EXTENDIDOS CON DOSIS ASCENDENTES
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 05294269
Patent: Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0516247
Patent: métodos de tratamento hormonal, utilizando regimes de ciclo prolongado de dose crescente
Estimated Expiration: ⤷ Sign Up
Patent: 0716291
Patent: MÉTODO DE CONTRACEPÇÃO E KITS FARMACÊUTICOS
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 82530
Patent: PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES A CYCLE ETENDU A AUGMENTATION DE DOSAGE (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS)
Estimated Expiration: ⤷ Sign Up
Patent: 68211
Patent: PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES CYCLIQUES PROLONGES A DOSES CROISSANTES (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1068552
Patent: Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Estimated Expiration: ⤷ Sign Up
Patent: 1626760
Patent: Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 14556
Patent: PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES A CYCLE ETENDU A AUGMENTATION DE DOSAGE (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS)
Estimated Expiration: ⤷ Sign Up
Patent: 79461
Patent: PROCÉDÉS DE TRAITEMENT HORMONAL UTILISANT DES SCHÉMAS POSOLOGIQUES CYCLIQUES PROLONGÉS À DOSES CROISSANTES (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS)
Estimated Expiration: ⤷ Sign Up
Patent: 92332
Patent: Procédé de traitement hormonal utilisant des régimes de cycle étendu à dose croissante (Methods of hormonal treatment utilizing ascending-dose extended cycle regimens)
Estimated Expiration: ⤷ Sign Up
Patent: 92333
Patent: Procédé de traitement hormonal utilisant des régimes de cycle étendu à dose croissante (Methods of hormonal treatment utilizing ascending-dose extended cycle regimens)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8441
Patent: שיטות למניעת הריון בנקבות בשימוש במינונים הורמוניים עולים (Methods of female contraception using ascending hormonal dosages)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08515909
Estimated Expiration: ⤷ Sign Up
Patent: 10508275
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07004120
Patent: METODOS DE TRATAMIENTO HORMONAL UTILIZANDO REGIMENTES DE CICLO PROLONGADO DE DOSIS ASCENDENTE. (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS.)
Estimated Expiration: ⤷ Sign Up
Patent: 09004616
Patent: METODOS DE TRATAMIENTO HORMONAL QUE UTILIZAN REGIMENES DE CICLO EXTENDIDO DE DOSIS ASCENDENTE. (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS.)
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 09120528
Patent: СПОСОБЫ ГОРМОНАЛЬНОЙ ТЕРАПИИ ВОЗРАСТАЮЩИМИ ДОЗАМИ В РЕЖИМЕ ПРОЛОНГИРОВАННОГО ЦИКЛА
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090094437
Patent: METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0626161
Patent: Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Estimated Expiration: ⤷ Sign Up
Patent: 0831107
Patent: Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
Australia | 2005294269 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens | ⤷ Sign Up |
European Patent Office | 2079461 | PROCÉDÉS DE TRAITEMENT HORMONAL UTILISANT DES SCHÉMAS POSOLOGIQUES CYCLIQUES PROLONGÉS À DOSES CROISSANTES (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS) | ⤷ Sign Up |
South Korea | 20090094437 | METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS | ⤷ Sign Up |
Canada | 2668211 | PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES CYCLIQUES PROLONGES A DOSES CROISSANTES (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS) | ⤷ Sign Up |
Brazil | PI0716291 | MÉTODO DE CONTRACEPÇÃO E KITS FARMACÊUTICOS | ⤷ Sign Up |
Mexico | 2007004120 | METODOS DE TRATAMIENTO HORMONAL UTILIZANDO REGIMENTES DE CICLO PROLONGADO DE DOSIS ASCENDENTE. (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS.) | ⤷ Sign Up |
Canada | 2582530 | PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES A CYCLE ETENDU A AUGMENTATION DE DOSAGE (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QUARTETTE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
1453521 | 39/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
0771217 | 07C0001 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
1453521 | 122015000093 | Germany | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
0136011 | 2000C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |