Methimazole - Generic Drug Details

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

Methimazole is the generic ingredient in two branded drugs marketed by Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Qingdao Baheal Pharm, Rising, Sun Pharm Inds Inc, King Pharms, and King Pharms Llc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for methimazole. Fifteen suppliers are listed for this compound.

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
The First Affiliated Hospital of Xiamen University	Phase 2/Phase 3
Beijing Tongren Hospital	Early Phase 1

Sponsor

Phase

Case Comprehensive Cancer Center

Phase 2

The First Affiliated Hospital of Xiamen University

Phase 2/Phase 3

Beijing Tongren Hospital

Early Phase 1

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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
Mylan	METHIMAZOLE	methimazole	TABLET;ORAL	040350-001	Mar 29, 2000	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	METHIMAZOLE	methimazole	TABLET;ORAL	209827-002	May 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharma	METHIMAZOLE	methimazole	TABLET;ORAL	040734-001	Dec 14, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	METHIMAZOLE	methimazole	TABLET;ORAL	209827-001	May 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	METHIMAZOLE	methimazole	TABLET;ORAL	218149-002	Sep 25, 2023	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

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	22
Patent Applications:	5,310
Drug Prices:	Drug price trends for methimazole
Drug Sales Revenues:	Drug sales revenues for methimazole
What excipients (inactive ingredients) are in methimazole?	methimazole excipients list
DailyMed Link:	methimazole at DailyMed

Drug Class	Thyroid Hormone Synthesis Inhibitor
Mechanism of Action	Thyroid Hormone Synthesis Inhibitors