Penicillamine - Generic Drug Details

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What are the generic drug sources for penicillamine and what is the scope of patent protection?

Penicillamine is the generic ingredient in four branded drugs marketed by Valeant Pharms Intl, Ani Pharms, Apotex, Breckenridge, Dr Reddys, Endo Operations, Granules, Invagen Pharms, Navinta Llc, Watson Labs Inc, Mylan Speciality Lp, Lupin Ltd, and Teva Pharms Usa, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for penicillamine. Fourteen suppliers are listed for this compound.

Sponsor	Phase
Nanfang Hospital, Southern Medical University	Phase 2
Alexion Pharmaceuticals	Phase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University	Early Phase 1

Sponsor

Phase

Nanfang Hospital, Southern Medical University

Phase 2

Alexion Pharmaceuticals

Phase 2

Second Affiliated Hospital, School of Medicine, Zhejiang 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
Endo Operations	PENICILLAMINE	penicillamine	CAPSULE;ORAL	211231-001	Dec 23, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Navinta Llc	PENICILLAMINE	penicillamine	CAPSULE;ORAL	214363-001	Oct 8, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	PENICILLAMINE	penicillamine	CAPSULE;ORAL	210976-001	Jun 24, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	PENICILLAMINE	penicillamine	TABLET;ORAL	211196-001	Dec 23, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	LUXZYLA	penicillamine	CAPSULE;ORAL	209921-001	May 7, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Breckenridge	PENICILLAMINE	penicillamine	CAPSULE;ORAL	215409-001	Aug 23, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	DEPEN	penicillamine	TABLET;ORAL	019854-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ 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:	4
Applicants:	13
NDAs:	14
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	17
Patent Applications:	7,057
Drug Prices:	Drug price trends for penicillamine
What excipients (inactive ingredients) are in penicillamine?	penicillamine excipients list
DailyMed Link:	penicillamine at DailyMed