PENICILLAMINE - Generic Drug Details

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

Penicillamine is the generic ingredient in three branded drugs marketed by Valeant Pharms Intl, Ani Pharms, Apotex, Breckenridge, Dr Reddys, Granules, Invagen Pharms, Navinta Llc, Par Pharm Inc, 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
Alexion Pharmaceuticals	Phase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University	Early Phase 1
GMP-Orphan SAS	Phase 3

Sponsor

Phase

Alexion Pharmaceuticals

Phase 2

Second Affiliated Hospital, School of Medicine, Zhejiang University

Early Phase 1

GMP-Orphan SAS

Phase 3

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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
Lupin Ltd	PENICILLAMINE	penicillamine	TABLET;ORAL	212933-001	Nov 30, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Breckenridge	PENICILLAMINE	penicillamine	CAPSULE;ORAL	215409-001	Aug 23, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PENICILLAMINE	penicillamine	CAPSULE;ORAL	213310-001	Apr 28, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm Inc	PENICILLAMINE	penicillamine	CAPSULE;ORAL	211231-001	Dec 23, 2019	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:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	16
Patent Applications:	6,743
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for PENICILLAMINE
What excipients (inactive ingredients) are in PENICILLAMINE?	PENICILLAMINE excipients list
DailyMed Link:	PENICILLAMINE at DailyMed