seasonique Drug Patent Profile
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Which patents cover Seasonique, and what generic alternatives are available?
Seasonique 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 sixty-three patent family members in twenty-two countries.
The generic ingredient in SEASONIQUE 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 Seasonique
Annual sales in 2021 were $6mm indicating the motivation for generic entry (peak sales were $109mm in 2011).
There has been one patent litigation case 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
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Questions you can ask:
- What is the 5 year forecast for seasonique?
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- What is Average Wholesale Price for seasonique?
Summary for seasonique
International Patents: | 63 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 5 |
Drug Prices: | Drug price information for seasonique |
Drug Sales Revenues: | Drug sales revenues for seasonique |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for seasonique |
What excipients (inactive ingredients) are in seasonique? | seasonique excipients list |
DailyMed Link: | seasonique at DailyMed |
![seasonique drug patent expirations Drug patent expirations by year for seasonique](/p/graph/s/t/seasonique-patent-expirations.png)
![Drug Prices for seasonique](/p/graph/drug-price/seasonique.png)
See drug prices for seasonique
![Drug Sales Revenue Trends for seasonique](/p/graph/drug-sales-revenues/seasonique.png)
Recent Clinical Trials for seasonique
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Duramed Research | Phase 3 |
Duramed Research | Phase 2 |
Paragraph IV (Patent) Challenges for SEASONIQUE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SEASONIQUE | Tablets | ethinyl estradiol; levonorgestrel | 0.15 mg/0.03 mg/0.01 mg | 021840 | 2008-01-22 |
US Patents and Regulatory Information for seasonique
seasonique is protected by two US patents.
Patents protecting seasonique
Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION
Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
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 | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | 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 seasonique
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for seasonique
See the table below for patents covering seasonique around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2524474 | METHODES DE TRAITEMENT HORMONAL FAISANT APPEL A DES SCHEMAS CONTRACEPTIFS A CYCLE PROLONGE (METHODS OF HORMONAL TREATMENT UTILIZING EXTENDED CYCLE CONTRACEPTIVE REGIMENS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 03049744 | ⤷ Sign Up | |
Slovenia | 1453521 | ⤷ Sign Up | |
China | 100581550 | ⤷ Sign Up | |
New Zealand | 533242 | Oral extended regime contraceptive package | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2005007112 | ⤷ Sign Up | |
Australia | 2010201022 | Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for seasonique
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1214076 | SZ 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
1453521 | C20160011 00192 | Estonia | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015 |
1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
0771217 | 07C0001 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
1453521 | C 2015 029 | Romania | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |