ACITRETIN - Generic Drug Details

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

Acitretin is the generic ingredient in two branded drugs marketed by Alembic, Barr Labs Inc, Impax Labs Inc, Mylan, Norvium Bioscience, Sigmapharm Labs Llc, Teva Pharms Usa, and Stiefel Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for acitretin. Eight suppliers are listed for this compound.

Sponsor	Phase
Singapore General Hospital	Phase 4
Translational Immunology Institute	Phase 4
South Valley University	Phase 4

Sponsor

Phase

Singapore General Hospital

Phase 4

Translational Immunology Institute

Phase 4

South Valley University

Phase 4

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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
Norvium Bioscience	ACITRETIN	acitretin	CAPSULE;ORAL	203707-002	Sep 10, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sigmapharm Labs Llc	ACITRETIN	acitretin	CAPSULE;ORAL	204633-001	May 22, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	ACITRETIN	acitretin	CAPSULE;ORAL	202552-002	Dec 23, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sigmapharm Labs Llc	ACITRETIN	acitretin	CAPSULE;ORAL	204633-004	May 22, 2015	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	ACITRETIN	acitretin	CAPSULE;ORAL	217774-001	Aug 5, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Stiefel Labs Inc	SORIATANE	acitretin	CAPSULE;ORAL	019821-003	Aug 6, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sigmapharm Labs Llc	ACITRETIN	acitretin	CAPSULE;ORAL	204633-002	May 22, 2015	AB	RX	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

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	37
Patent Applications:	6,746
Drug Prices:	Drug price trends for ACITRETIN
What excipients (inactive ingredients) are in ACITRETIN?	ACITRETIN excipients list
DailyMed Link:	ACITRETIN at DailyMed