DrugPatentWatch Database Preview
SEASONIQUE Drug Profile
Which patents cover Seasonique, and when can generic versions of Seasonique launch?
Seasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There are four 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for SEASONIQUE
| International Patents: | 63 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 5 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SEASONIQUE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SEASONIQUE |
| DailyMed Link: | SEASONIQUE at DailyMed |
See drug prices for SEASONIQUE
Recent Clinical Trials for SEASONIQUE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duramed Research | Phase 3 |
| Duramed Research | Phase 2 |
Recent Litigation for SEASONIQUE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teva Women's Health, Inc. v. Famy Care Ltd. | 2014-12-05 |
| TEVA WOMEN'S HEALTH, INC. v. MYLAN PHARMACEUTICALS, INC. | 2010-03-09 |
| TEVA WOMEN'S HEALTH, INC. v. LUPIN, LTD. | 2010-02-03 |
US Patents and Regulatory Information for SEASONIQUE
| 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 | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for SEASONIQUE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 0.15 mg/0.03 mg/0.01 mg | ➤ Subscribe | Start Trial |
International Patents for SEASONIQUE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 585546 | Start Trial |
| Denmark | 1453521 | Start Trial |
| Canada | 2524474 | Start Trial |
| Russian Federation | 2010118424 | Start Trial |
| European Patent Office | 1648382 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SEASONIQUE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1380301 | 2009C/007 | Belgium | Start Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1453521 | 39/2015 | Austria | Start Trial | 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 | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| 1453521 | 300814 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY |
| 0136011 | 2000C/027 | Belgium | Start Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
