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Last Updated: August 14, 2020

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ELESTRIN Drug Profile

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

Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-five patent family members in twenty countries.

The generic ingredient in ELESTRIN is estradiol. There are seventy-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

US ANDA Litigation and Generic Entry Outlook for Elestrin

A generic version of ELESTRIN was approved as estradiol by MAYNE PHARMA on March 14th, 1996.

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Drug patent expirations by year for ELESTRIN
Drug Prices for ELESTRIN

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Drug Sales Revenue Trends for ELESTRIN

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Recent Clinical Trials for ELESTRIN

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SponsorPhase
University of Missouri-ColumbiaN/A

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Pharmacology for ELESTRIN
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ELESTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813-001 Dec 15, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813-001 Dec 15, 2006 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

Supplementary Protection Certificates for ELESTRIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 12/2004 Austria   Start Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0770388 SPC/GB09/026 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Johnson and Johnson
Harvard Business School
Dow
Express Scripts

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