Propylthiouracil - Generic Drug Details

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

Propylthiouracil is the generic ingredient in one branded drug marketed by Abbott, Actavis Elizabeth, Anabolic, Ani Pharms, Chartwell Molecular, Chartwell Rx, Endo Operations, Halsey, Impax Labs, Lilly, Macleods Pharms Ltd, Quagen, Sun Pharm Industries, Tablicaps, and Watson Labs, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for propylthiouracil. Eight suppliers are listed for this compound.

Summary for propylthiouracil

US Patents:	0
Tradenames:	1
Applicants:	15
NDAs:	16
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	12
Patent Applications:	6,152
Drug Prices:	Drug price trends for propylthiouracil
What excipients (inactive ingredients) are in propylthiouracil?	propylthiouracil excipients list
DailyMed Link:	propylthiouracil at DailyMed

See drug prices for propylthiouracil

Recent Clinical Trials for propylthiouracil

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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
Maastricht University	Phase 2
European Commission	Phase 1

See all propylthiouracil clinical trials

Pharmacology for propylthiouracil

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

Medical Subject Heading (MeSH) Categories for propylthiouracil

Antimetabolites
Antithyroid Agents

Anatomical Therapeutic Chemical (ATC) Classes for propylthiouracil

H03BA	Thiouracils
H03B	ANTITHYROID PREPARATIONS
H03	THYROID THERAPY
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for propylthiouracil

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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
Macleods Pharms Ltd	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	208867-001	May 10, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080215-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	085201-001	Approved Prior to Jan 1, 1982		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

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