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Last Updated: August 4, 2020

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Anastrozole - Generic Drug Details

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

Anastrozole is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex Inc, Beijing Yiling, Cipla, Fresenius Kabi Usa, Hikma, Impax Labs Inc, Kenton, Lannett Co Inc, Mylan, Natco Pharma Ltd, Neopharma, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, Zydus Pharms Usa Inc, and Ani Pharms Inc, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for anastrozole. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for anastrozole

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Drug Sales Revenue Trends for anastrozole

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Recent Clinical Trials for anastrozole

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SponsorPhase
Hoffmann-La RochePhase 2
The Affiliated Hospital of Qingdao UniversityPhase 1
Jiangsu HengRui Medicine Co., Ltd.Phase 2

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Generic filers with tentative approvals for ANASTROZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for anastrozole
Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors

US Patents and Regulatory Information for anastrozole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms ANASTROZOLE anastrozole TABLET;ORAL 078058-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma ANASTROZOLE anastrozole TABLET;ORAL 078485-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa ANASTROZOLE anastrozole TABLET;ORAL 090088-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ANASTROZOLE anastrozole TABLET;ORAL 090568-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc ANASTROZOLE anastrozole TABLET;ORAL 091242-001 May 31, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla ANASTROZOLE anastrozole TABLET;ORAL 091164-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd ANASTROZOLE anastrozole TABLET;ORAL 091177-001 Jul 15, 2011 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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