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Last Updated: November 22, 2024

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 Pfizer, Alvogen, Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms, and is included in twelve 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.

Summary for EXEMESTANE
Drug Prices for EXEMESTANE

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Recent Clinical Trials for EXEMESTANE

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

SponsorPhase
Breast Cancer Research FoundationPhase 2
QuantumLeap Healthcare CollaborativePhase 2
NRG OncologyPhase 2

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
Upsher Smith Labs EXEMESTANE exemestane TABLET;ORAL 209208-001 Jul 26, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Breckenridge EXEMESTANE exemestane TABLET;ORAL 211031-001 Feb 21, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Qilu EXEMESTANE exemestane TABLET;ORAL 213547-001 Apr 13, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa EXEMESTANE exemestane TABLET;ORAL 208764-001 Aug 8, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alvogen EXEMESTANE exemestane TABLET;ORAL 200898-001 Jul 28, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms EXEMESTANE exemestane TABLET;ORAL 202602-001 Oct 3, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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