SEASONALE Drug Patent Profile
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Which patents cover Seasonale, and when can generic versions of Seasonale launch?
Seasonale is a drug marketed by Teva Branded Pharm and is included in one NDA.
The generic ingredient in SEASONALE 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.
Summary for SEASONALE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 4 |
Formulation / Manufacturing: | see details |
DailyMed Link: | SEASONALE at DailyMed |
Recent Clinical Trials for SEASONALE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Duramed Research | Phase 2 |
The Hospital for Sick Children | Phase 3 |
The Physicians' Services Incorporated Foundation | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for SEASONALE
Paragraph IV (Patent) Challenges for SEASONALE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SEASONALE | Tablets | ethinyl estradiol; levonorgestrel | 0.15 mg/0.03 mg | 021544 | 2004-03-29 |
US Patents and Regulatory Information for SEASONALE
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 | SEASONALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021544-001 | Sep 5, 2003 | 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 SEASONALE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | SEASONALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021544-001 | Sep 5, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Branded Pharm | SEASONALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021544-001 | Sep 5, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SEASONALE
See the table below for patents covering SEASONALE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69804918 | ⤷ Try a Trial | |
Canada | 2256977 | METHODES DE CONTRACEPTION ORALE COMPRENANT UNE UTILISATION PROLONGEE DE L'AGENT CONTRACEPTIF (METHODS OF EXTENDED USE ORAL CONTRACEPTION) | ⤷ Try a Trial |
Norway | 982815 | ⤷ Try a Trial | |
European Patent Office | 0911029 | Contraceptif oral à tres faibles doses, ayant une activité prolongée et provoquant moins d'hemorragies menstruelles (Ultra low dose oral contraceptives with less menstrual bleeding and sustained efficacy) | ⤷ Try a Trial |
Portugal | 911029 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SEASONALE
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 |
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 |
1453521 | 15C0050 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |