LETROZOLE - Generic Drug Details

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What are the generic sources for letrozole and what is the scope of patent protection?

Letrozole is the generic ingredient in three branded drugs marketed by Novartis Pharms, Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Natco Pharma Ltd, Norvium Bioscience, Ryan Labs, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Novartis, and is included in twenty-two NDAs. There are nine 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. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for LETROZOLE

US Patents:	9
Tradenames:	3
Applicants:	21
NDAs:	22
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	596
Patent Applications:	7,505
Drug Prices:	Drug price trends for LETROZOLE
Drug Sales Revenues:	Drug sales revenues for LETROZOLE
What excipients (inactive ingredients) are in LETROZOLE?	LETROZOLE excipients list
DailyMed Link:	LETROZOLE at DailyMed

See drug prices for LETROZOLE

See drug sales revenues for LETROZOLE

Recent Clinical Trials for LETROZOLE

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

Sponsor	Phase
Mridula George, MD	Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
Verastem, Inc.	Phase 3

See all LETROZOLE clinical trials

Generic filers with tentative approvals for LETROZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	2.5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	200MG;2.5MG	TABLET;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 LETROZOLE

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LETROZOLE

L02BG	Aromatase inhibitors
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LETROZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FEMARA	Tablets	letrozole	2.5 mg	020726	1	2006-03-02

US Patents and Regulatory Information for LETROZOLE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	LETROZOLE	letrozole	TABLET;ORAL	091638-001	Jun 3, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ryan Labs	LETROZOLE	letrozole	TABLET;ORAL	091191-001	Jun 3, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	LETROZOLE	letrozole	TABLET;ORAL	090789-001	Jun 3, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	LETROZOLE	letrozole	TABLET;ORAL	091303-001	Apr 19, 2012		DISCN	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

Expired US Patents for LETROZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms	FEMARA	letrozole	TABLET;ORAL	020726-001	Jul 25, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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