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
Cheloo Hospital (Qingdao), Shandong University	Early Phase 1
The Second Affiliated Hospital of Air Force Military Medical University	Early Phase 1

Sponsor

Phase

Case Comprehensive Cancer Center

Phase 2

Cheloo Hospital (Qingdao), Shandong University

Early Phase 1

The Second Affiliated Hospital of Air Force Military Medical University

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	040350-002	Mar 29, 2000	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
King Pharms Llc	TAPAZOLE	methimazole	TABLET;ORAL	040320-002	Mar 31, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
King Pharms Llc	TAPAZOLE	methimazole	TABLET;ORAL	040320-001	Mar 31, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Discovery Therap	METHIMAZOLE	methimazole	TABLET;ORAL	040619-003	Jul 12, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	METHIMAZOLE	methimazole	TABLET;ORAL	040350-003	Jun 7, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bionpharma	METHIMAZOLE	methimazole	TABLET;ORAL	218149-001	Sep 25, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	METHIMAZOLE	methimazole	TABLET;ORAL	202068-002	Mar 7, 2012	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

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:	21
Patent Applications:	5,791
Formulation / Manufacturing:	see details
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