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Serving leading biopharmaceutical companies globally:

Queensland Health
Moodys
McKinsey
Fuji
Dow
Federal Trade Commission
Baxter
US Department of Justice
Medtronic
Mallinckrodt

Generated: January 17, 2018

DrugPatentWatch Database Preview

Letrozole - Generic Drug Details

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

Letrozole
is the generic ingredient in three branded drugs marketed by Novartis Pharms, Accord Hlthcare, Actavis Totowa, Apotex Inc, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Hikma Pharms, Impax Labs, Indicus Pharma, Jiangsu Hengrui Med, Kremers Urban Pharms, Lannett Holdings Inc, Mylan, Natco Pharma Ltd, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Vintage Pharms Llc, West-ward Pharms Int, and Novartis Pharms Corp, and is included in twenty NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for letrozole. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for letrozole
Drug ClassAromatase Inhibitor
Mechanism of ActionAromatase Inhibitors
Tentative approvals for LETROZOLE
Applicant Application No. Strength Dosage Form
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US Patents and Regulatory Information for letrozole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd LETROZOLE letrozole TABLET;ORAL 091466-001 Jun 3, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis Pharms FEMARA letrozole TABLET;ORAL 020726-001 Jul 25, 1997 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Natco Pharma Ltd LETROZOLE letrozole TABLET;ORAL 200161-001 Jun 3, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan LETROZOLE letrozole TABLET;ORAL 078190-001 Dec 24, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Indicus Pharma LETROZOLE letrozole TABLET;ORAL 201804-001 Jun 3, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hikma Pharms LETROZOLE letrozole TABLET;ORAL 203796-001 Jun 3, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Kremers Urban Pharms LETROZOLE letrozole TABLET;ORAL 091098-001 Jun 3, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jiangsu Hengrui Med LETROZOLE letrozole TABLET;ORAL 202716-001 May 16, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET, TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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:

Baxter
Federal Trade Commission
Chubb
Johnson and Johnson
Medtronic
Accenture
Harvard Business School
AstraZeneca
UBS

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