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LOSEASONIQUE Drug Profile
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When do Loseasonique patents expire, and what generic alternatives are available?
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 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
Loseasonique was eligible for patent challenges on December 31, 1968.
There have been three 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 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 |
| DailyMed Link: | LOSEASONIQUE at DailyMed |
Recent Litigation for LOSEASONIQUE
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. | 2010-01-06 |
Synonyms for LOSEASONIQUE
| 110541-57-6 |
| 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17-alpha)-, mixt. with (17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol |
| 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17-alpha)-(+-)-, mixt. with (17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol |
| 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17-alpha)-(+-)-,mixt. with (17-alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol |
| 37263-36-8 |
| 39366-37-5 |
| 52232-43-6 |
| 55927-62-3 |
| 70208-30-9 |
| 8056-51-7 |
| 8063-84-1 |
| 8064-50-4 |
| AC1L2NM9 |
| Adepal |
| AG 200-15 |
| AG200-15 |
| aless |
| Alesse 28 |
| Altavera |
| Anna |
| Anteovin |
| aviane |
| AVIANE-21 |
| Aviane-21Fe |
| AVIANE-28 |
| Biphasil |
| Biphasil 21 |
| Biphasil 28 |
| C21H28O2.C20H24O2 |
| CCRIS 7261 |
| CRYSELLE |
| dl-Norgestrel mixed with ethinylestradiol |
| DTXSID90192569 |
| Duoluton |
| Ediwal |
| Elifemme |
| ENPRESSE-21 |
| ENPRESSE-28 |
| Ethinyl estradiol mixed with norgestrel |
| Ethinyl estradiol mixture with levonorgestrel |
| Ethinyl estradiol mixture with norgestrel |
| ETHINYL ESTRADIOL-NORGESTREL COMBINATION |
| ethinyl estradiol, levonorgestrel drug combination |
| Ethinyl estradiol/levonorgestrel |
| Ethinylestradiol - levonorgestrel mixt |
| Ethinylestradiol - levonorgestrel mixt. |
| Ethinylestradiol mixed with dl-norgestrel |
| Ethinylestradiol mixture with Levonorgestrel |
| Ethinyloestradiol mixed with norgestrel |
| Eugynon |
| Eugynon 30 |
| Femenal |
| Follimin |
| Follinett |
| Follinyl |
| Gravistat |
| Gynatrol |
| Introvale |
| Jolessa |
| LESSINA-21 |
| LESSINA-28 |
| LEVLITE |
| Levonest |
| Levonorgestrel - ethynylestradiol mixt |
| Levonorgestrel - ethynylestradiol mixt. |
| Levonorgestrel and Ethinyl Estradiol |
| Levonorgestrel and Ethinyl Estradiol tablets |
| Levonorgestrel-ethinyl estradiol mixt |
| Levonorgestrel-ethinyl estradiol mixt. |
| Levonorgestrel, ethinyl estradiol |
| Levonorgestrel/ethinyl estradiol |
| Levora |
| LEVORA 0.15/30-21 |
| LEVORA 0.15/30-28 |
| Lo-Femenal |
| LO/OVRAL-28 |
| LOC 31 |
| LOC 31A |
| Logynon |
| Low-ogestrel |
| LOW-OGESTREL-21 |
| LOW-OGESTREL-28 |
| LS-62088 |
| LS-62092 |
| Lybrel |
| Marlissa |
| Microgynon |
| Microgynon 30 |
| Microvlar 30 |
| Minidril |
| Minigynon |
| Minisiston |
| Neogynon |
| Neovlar |
| Neovletta |
| NORDETTE-21 |
| NORDETTE-28 |
| Nordiol |
| Nordiol-28 |
| Norgestrel and Ethinyl Estradiol |
| Norgestrel mixed with ethinyl estradiol |
| Norgestrel mixed with ethinyloestradiol |
| Norgestrel-ethinyl estradiol |
| Norgestrel-Ethinyl Estradiol Combination |
| Norgestrel-ethynylestradiol mixt |
| Norgestrel-ethynylestradiol mixt. |
| OGESTREL 0.5/50-21 |
| OGESTREL 0.5/50-28 |
| Orasecron |
| Ovidon |
| Ovral 21 |
| Ovral 28 |
| Ovral L |
| OVRAL-28 |
| Ovran |
| Ovranett |
| PC 4 (contraceptive) |
| Pearl Oral Contraceptive |
| Portia |
| PORTIA-21 |
| PORTIA-28 |
| PREVEN EMERGENCY CONTRACEPTIVE KIT |
| Primovlar |
| Pro-Duosterone |
| Quartette |
| Quasense |
| Rigevidon |
| SCHEMBL4451192 |
| Schering PC 4 |
| Sequilar |
| Sequilarum |
| Sequostat |
| SH 71121 |
| SH D00264A |
| SHB 261AB |
| SHB 264AB |
| Sronyx |
| Stederil 30 |
| Stediril |
| Stediril D |
| Tri-Regol |
| Trigynon |
| Trikvilar |
| Trinordiol |
| Triphasil-21 |
| TRIPHASIL-28 |
| Triquilar |
| Trisiston |
| Trisistone R |
| Trisistone-R |
| TRIVORA-21 |
| TRIVORA-28 |
| Twirla |
| Vienva |
| WL 33 |
| WY-E 104 |
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 |
|---|---|---|
| Hungary | 230759 | Start Trial |
| South Africa | 200404249 | Start Trial |
| Japan | 2010180236 | Start Trial |
| Canada | 2524474 | Start Trial |
| China | 101757628 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LOSEASONIQUE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | CA 2006 00038 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 0398460 | C300221 | Netherlands | Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1380301 | 2009C/007 | Belgium | Start Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1380301 | CA 2009 00017 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
