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Last Updated: August 8, 2020

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ACTIVELLA Drug Profile

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Which patents cover Activella, and when can generic versions of Activella launch?

Activella is a drug marketed by Amneal Pharms Llc 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. Eight suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Drug patent expirations by year for ACTIVELLA
Drug Prices for ACTIVELLA

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Drug Sales Revenue Trends for ACTIVELLA

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Recent Clinical Trials for ACTIVELLA

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SponsorPhase
Gretchen WellsPhase 4
Teva Pharmaceuticals USAPhase 1

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Pharmacology 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 Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-002 Dec 28, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ACTIVELLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011 97C0056 Belgium   Start Trial PRODUCT NAME: OESTROGENES CONJUGUES + MEDROXYPROGESTERONACETAS; NAT. REGISTRATION NO/DATE: 428 IS 194 F 3 19970520; FIRST REGISTRATION: CH 52649 19940826
0136011 SPC/GB00/028 United Kingdom   Start Trial SPC/GB00/028: 20040802, EXPIRES: 20090801
0136011 C00136011/03 Switzerland   Start Trial PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
Baxter
Mallinckrodt
AstraZeneca
McKesson

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