DrugPatentWatch Database Preview
SEASONIQUE Drug Profile
» See Plans and Pricing
When do Seasonique patents expire, 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. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
US ANDA Litigation and Generic Entry Outlook for Seasonique
There have been five patent litigation cases 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
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 |
Paragraph IV (Patent) Challenges for SEASONIQUE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SEASONIQUE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 021840 | 2008-01-22 |
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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SEASONIQUE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2005516913 | Start Trial |
| New Zealand | 545130 | Start Trial |
| Israel | 162182 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SEASONIQUE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | C20160011 00192 | Estonia | Start Trial | PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015 |
| 1453521 | 122015000093 | Germany | Start Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 1453521 | 300814 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
