Tiopronin - Generic Drug Details

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

Tiopronin is the generic ingredient in three branded drugs marketed by Mission Pharmacal, Amneal, Par Pharm, Torrent, Mission Pharma, Par Pharm Inc, and Teva Pharms Usa Inc, and is included in seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for tiopronin. Four suppliers are listed for this compound.

Sponsor	Phase
NYU Langone Health	Phase 2
New York University School of Medicine	Phase 2
Revive Therapeutics, Ltd.	Phase 2

Sponsor

Phase

NYU Langone Health

Phase 2

New York University School of Medicine

Phase 2

Revive Therapeutics, Ltd.

Phase 2

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THIOLA EC	Delayed-release Tablets	tiopronin	100 mg and 300 mg	211843	2	2022-10-11

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

Delayed-release Tablets

100 mg and 300 mg

2022-10-11

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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
Par Pharm	TIOPRONIN	tiopronin	TABLET, DELAYED RELEASE;ORAL	217219-002	Feb 24, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm Inc	TIOPRONIN	tiopronin	TABLET;ORAL	216198-001	Jun 2, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa Inc	TIOPRONIN	tiopronin	TABLET;ORAL	214326-001	Apr 26, 2021	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:	1
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	5
Patent Applications:	2,804
What excipients (inactive ingredients) are in tiopronin?	tiopronin excipients list
DailyMed Link:	tiopronin at DailyMed

Drug Class	Reducing and Complexing Thiol
Mechanism of Action	Cystine Disulfide Reduction