ACTIVELLA Drug Patent Profile
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Which patents cover Activella, and when can generic versions of Activella launch?
Activella is a drug marketed by Amneal and is included in one NDA.
The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Activella
A generic version of ACTIVELLA was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17th, 2008.
Summary for ACTIVELLA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 6 |
Patent Applications: | 5,659 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ACTIVELLA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTIVELLA |
What excipients (inactive ingredients) are in ACTIVELLA? | ACTIVELLA excipients list |
DailyMed Link: | ACTIVELLA at DailyMed |
Recent Clinical Trials for ACTIVELLA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AbbVie | Phase 3 |
Gretchen Wells | Phase 4 |
AbbVie | Phase 2 |
Pharmacology for ACTIVELLA
Drug Class | Estrogen Progestin |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ACTIVELLA
US Patents and Regulatory Information for ACTIVELLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-002 | Dec 28, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for ACTIVELLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTIVELLA
See the table below for patents covering ACTIVELLA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 10199010 | ⤷ Try a Trial | |
Germany | 10075037 | ⤷ Try a Trial | |
Germany | 19775086 | ⤷ Try a Trial | |
Luxembourg | 90107 | ⤷ Try a Trial | |
Denmark | 165390 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTIVELLA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0136011 | 2000C/027 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
0136011 | SPC/GB98/034 | United Kingdom | ⤷ Try a Trial | SPC/GB98/034: 20040802, EXPIRES: 20090801 |
0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
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 |
0136011 | 980038 | Netherlands | ⤷ Try a Trial | 980038, 20090801, EXPIRES: 20130305 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |