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Last Updated: October 20, 2020

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EXEMESTANE - Generic Drug Details

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What are the generic sources for exemestane and what is the scope of freedom to operate?

Exemestane is the generic ingredient in two branded drugs marketed by Pharmacia And Upjohn, Alvogen, Amneal Pharms, Breckenridge, Cipla, Hikma, Mayne Pharma Inc, Mylan, Qilu, Upsher Smith Labs, and Zydus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for exemestane. Thirteen suppliers are listed for this compound.

Drug Prices for EXEMESTANE

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Recent Clinical Trials for EXEMESTANE

Identify potential brand extensions & 505(b)(2) entrants

First Affiliated Hospital, Sun Yat-Sen UniversityPhase 2
Fudan UniversityPhase 2
Istituto Di Ricerche Farmacologiche Mario NegriPhase 3

See all EXEMESTANE clinical trials

Pharmacology for EXEMESTANE
Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors

US Patents and Regulatory Information for EXEMESTANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms EXEMESTANE exemestane TABLET;ORAL 206421-001 Dec 28, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Alvogen EXEMESTANE exemestane TABLET;ORAL 200898-001 Jul 28, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma EXEMESTANE exemestane TABLET;ORAL 077431-001 Apr 1, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc EXEMESTANE exemestane TABLET;ORAL 208764-001 Aug 8, 2019 DISCN No 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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