DrugPatentWatch Database Preview
LOSEASONIQUE Drug Profile
» See Plans and Pricing
When do Loseasonique patents expire, and when can generic versions of Loseasonique launch?
Loseasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There are three 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 LOSEASONIQUE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-one 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 Loseasonique
There has been one patent litigation case 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 LOSEASONIQUE
| International Patents: | 63 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 2 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LOSEASONIQUE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LOSEASONIQUE |
| What excipients (inactive ingredients) are in LOSEASONIQUE? | LOSEASONIQUE excipients list |
| DailyMed Link: | LOSEASONIQUE at DailyMed |
Paragraph IV (Patent) Challenges for LOSEASONIQUE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LOSEASONIQUE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 022262 | 2009-11-16 |
US Patents and Regulatory Information for LOSEASONIQUE
| 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 | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | AB | RX | No | No | Start Trial | Start Trial | Y | 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 LOSEASONIQUE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1453521 | Start Trial |
| Spain | 2428118 | Start Trial |
| Russian Federation | 2004121155 | Start Trial |
| New Zealand | 533242 | Start Trial |
| Australia | 2010201022 | Start Trial |
| Japan | 2007534622 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LOSEASONIQUE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | C 2015 029 | Romania | Start Trial | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
| 1453521 | C201630040 | Spain | Start Trial | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
| 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 |
| 1214076 | C01214076/01 | Switzerland | Start Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 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 |
| 0771217 | 07C0001 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
