EXEMESTANE - Generic Drug Details

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

Exemestane is the generic ingredient in two branded drugs marketed by Pfizer, Alvogen, Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for exemestane. Thirteen suppliers are listed for this compound.

Summary for EXEMESTANE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	252
Patent Applications:	5,922
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for EXEMESTANE
What excipients (inactive ingredients) are in EXEMESTANE?	EXEMESTANE excipients list
DailyMed Link:	EXEMESTANE at DailyMed

See drug prices for EXEMESTANE

Recent Clinical Trials for EXEMESTANE

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

Sponsor	Phase
QuantumLeap Healthcare Collaborative	Phase 2
Washington State University	Early Phase 1
Olema Pharmaceuticals, Inc.	Phase 3

See all EXEMESTANE clinical trials

Pharmacology for EXEMESTANE

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EXEMESTANE

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

US Patents and Regulatory Information for EXEMESTANE

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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
Alvogen	EXEMESTANE	exemestane	TABLET;ORAL	200898-001	Jul 28, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	EXEMESTANE	exemestane	TABLET;ORAL	209208-001	Jul 26, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	EXEMESTANE	exemestane	TABLET;ORAL	216454-001	May 20, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	EXEMESTANE	exemestane	TABLET;ORAL	210323-001	Apr 27, 2018	AB	RX	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 EXEMESTANE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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