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Last Updated: April 23, 2024

Anastrozole - Generic Drug Details

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What are the generic drug 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, Mylan, Natco Pharma Ltd, 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-three 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:	23
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	310
Patent Applications:	7,080
Formulation / Manufacturing:	see details
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
ETOP IBCSG Partners Foundation	Phase 2
University of Miami	Phase 2
Ottawa Hospital Research Institute	Phase 4

See all anastrozole clinical trials

Generic filers with tentative approvals for ANASTROZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	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

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
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	ANASTROZOLE	anastrozole	TABLET;ORAL	091242-001	May 31, 2012		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	ANASTROZOLE	anastrozole	TABLET;ORAL	079007-001	Jun 28, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	ANASTROZOLE	anastrozole	TABLET;ORAL	090088-001	Jun 28, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco Pharma Ltd	ANASTROZOLE	anastrozole	TABLET;ORAL	079220-001	Jun 28, 2010	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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