SEASONALE Drug Patent Profile
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When do Seasonale patents expire, 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 |
|---|---|---|---|
| Japan | H1129481 | ULTRA LOW DOSAGE CONTRACEPTIVE DECREASING BLEEDING AT MENSES AND HAVING SUSTAINED ACTIVITY | ⤷ Try a Trial |
| Germany | 69804918 | ⤷ Try a Trial | |
| Canada | 2596416 | ⤷ Try a Trial | |
| Norway | 982815 | ⤷ Try a Trial | |
| Japan | 2007197459 | ULTRA LOW DOSE CONTRACEPTIVE WITH LESS MENSTRUAL BLEEDING AND SUSTAINED EFFICACY | ⤷ 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 | 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 |
| 1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0771217 | CA 2006 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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