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QUARTETTE Drug Profile
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» See Plans and PricingWhich patents cover Quartette, and what generic alternatives are available?
Quartette is a drug marketed by Teva Branded Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-four patent family members in thirteen countries.
The generic ingredient in QUARTETTE 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 Quartette
There have been two 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 QUARTETTE
| International Patents: | 24 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 2 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QUARTETTE |
| Drug Sales Revenues: | Drug sales revenues for QUARTETTE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QUARTETTE |
| DailyMed Link: | QUARTETTE at DailyMed |
Recent Litigation for QUARTETTE
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. Famy Care Ltd. | 2014-07-02 |
Synonyms for QUARTETTE
| 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 |
| 39366-37-5 |
| 8056-51-7 |
| Adepal |
| AG 200-15 |
| AG200-15 |
| aless |
| Alesse |
| 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 |
| Loseasonique |
| 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 |
| 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 |
| 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 QUARTETTE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| QUARTETTE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 204061 | 2013-07-10 |
US Patents and Regulatory Information for QUARTETTE
| 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 | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | QUARTETTE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 204061-001 | Mar 28, 2013 | AB | RX | Yes | Yes | 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 QUARTETTE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2010508275 | Start Trial |
| Taiwan | 200626161 | Start Trial |
| Mexico | 2007004120 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for QUARTETTE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0771217 | 07C0001 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| 1453521 | 15C0050 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
