LILETTA Drug Patent Profile
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Which patents cover Liletta, and when can generic versions of Liletta launch?
Liletta is a drug marketed by Medicines360 and is included in one NDA. There are three patents protecting this drug.
This drug has thirty-three patent family members in nineteen countries.
The generic ingredient in LILETTA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Liletta
A generic version of LILETTA was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.
Summary for LILETTA
International Patents: | 33 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 2 |
Patent Applications: | 4,459 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LILETTA |
What excipients (inactive ingredients) are in LILETTA? | LILETTA excipients list |
DailyMed Link: | LILETTA at DailyMed |
Recent Clinical Trials for LILETTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eastern Virginia Medical School | Phase 4 |
CONRAD | Phase 4 |
United States Agency for International Development (USAID) | Phase 4 |
Pharmacology for LILETTA
Drug Class | Progestin Progestin-containing Intrauterine System |
Physiological Effect | Inhibit Ovum Fertilization |
Anatomical Therapeutic Chemical (ATC) Classes for LILETTA
US Patents and Regulatory Information for LILETTA
LILETTA is protected by three US patents and one FDA Regulatory Exclusivity.
Patents protecting LILETTA
Intrauterine systems, IUD insertion devices, and related methods and kits therefor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR PREVENTION OF PREGNANCY
Methods for using intrauterine systems and IUD insertion devices
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR PREVENTION OF PREGNANCY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting LILETTA
TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR UP TO 5 YEARS IN PATIENTS WHO CHOOSE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medicines360 | LILETTA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 206229-001 | Feb 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Medicines360 | LILETTA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 206229-001 | Feb 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Medicines360 | LILETTA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 206229-001 | Feb 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Medicines360 | LILETTA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 206229-001 | Feb 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 LILETTA
See the table below for patents covering LILETTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2015221468 | Intrauterine systems, IUD insertion devices, and related methods and kits therefor | ⤷ Try a Trial |
European Patent Office | 2731562 | SYSTÈMES INTRA-UTÉRINS, DISPOSITIFS D'INTRODUCTION DE DISPOSITIF INTRA-UTÉRIN (IUD), ET TROUSSES POUR CEUX-CI (INTRAUTERINE SYSTEMS, IUD INSERTION DEVICES, AND KITS THEREFOR) | ⤷ Try a Trial |
Brazil | 112020019403 | dispositivos de introdução de diu, e métodos relacionados e kits para os mesmos | ⤷ Try a Trial |
Brazil | 112014000440 | sistemas intrauterinos, dispositivos de inserção de diu, e métodos relativos e kits para os mesmos | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LILETTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 93156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
1453521 | 39/2015 | Austria | ⤷ Try a 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 |
1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |