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, Chartwell Molecular, Chartwell Rx, Cipla, Eugia Pharma, Fresenius Kabi Usa, Hikma, Impax Labs Inc, Kenton, Natco Pharma Ltd, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, Zydus Pharms Usa Inc, and Ani Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for anastrozole

US Patents:	0
Tradenames:	2
Applicants:	20
NDAs:	20
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	316
Patent Applications:	7,080
Drug Prices:	Drug price trends for anastrozole
Drug Sales Revenues:	Drug sales revenues for anastrozole
What excipients (inactive ingredients) are in anastrozole?	anastrozole excipients list
DailyMed Link:	anastrozole at DailyMed

See drug prices for anastrozole

Drug Sales Revenue Trends for anastrozole

See drug sales revenues for anastrozole

Recent Clinical Trials for anastrozole

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
University of Wisconsin, Madison	Phase 2
GOG Foundation	Phase 3

See all anastrozole clinical trials

Generic filers with tentative approvals for ANASTROZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1MG	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 anastrozole

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for anastrozole

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

US Patents and Regulatory Information for anastrozole

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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
Sandoz	ANASTROZOLE	anastrozole	TABLET;ORAL	079007-001	Jun 28, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Synthon Pharms	ANASTROZOLE	anastrozole	TABLET;ORAL	078322-001	Jun 28, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	ANASTROZOLE	anastrozole	TABLET;ORAL	078485-001	Jun 28, 2010		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 anastrozole

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	⤷ Sign Up	⤷ Sign Up
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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