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.
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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 |
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 | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | SEASONALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021544-001 | Sep 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Canada | 2256977 | METHODES DE CONTRACEPTION ORALE COMPRENANT UNE UTILISATION PROLONGEE DE L'AGENT CONTRACEPTIF (METHODS OF EXTENDED USE ORAL CONTRACEPTION) | ⤷ Sign Up |
| Spain | 2175650 | ⤷ Sign Up | |
| Denmark | 0911029 | ⤷ Sign Up | |
| Germany | 69804918 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SEASONALE
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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