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Last Updated: March 1, 2021

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ESTRASORB Drug Profile

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When do Estrasorb patents expire, and when can generic versions of Estrasorb launch?

Estrasorb is a drug marketed by Exeltis Usa Inc and is included in one NDA.

The generic ingredient in ESTRASORB is estradiol hemihydrate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol hemihydrate profile page.

US Patents and Regulatory Information for ESTRASORB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exeltis Usa Inc ESTRASORB estradiol hemihydrate EMULSION;TOPICAL 021371-001 Oct 9, 2003 DISCN Yes No   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 ESTRASORB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0770388 2009/012 Ireland   Start Trial PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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