ALPRAZOLAM - Generic Drug Details

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

Alprazolam is the generic ingredient in four branded drugs marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Anchen Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Upjohn, Par Pharm, Ucb Inc, Breckenridge, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, Sun Pharm, and Watson Labs, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for alprazolam. Thirty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALPRAZOLAM

US Patents:	0
Tradenames:	4
Applicants:	28
NDAs:	39
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	95
Patent Applications:	6,391
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ALPRAZOLAM
Drug Sales Revenues:	Drug sales revenues for ALPRAZOLAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALPRAZOLAM
What excipients (inactive ingredients) are in ALPRAZOLAM?	ALPRAZOLAM excipients list
DailyMed Link:	ALPRAZOLAM at DailyMed

See drug prices for ALPRAZOLAM

See drug sales revenues for ALPRAZOLAM

Recent Clinical Trials for ALPRAZOLAM

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

Sponsor	Phase
Centre Hospitalier Universitaire Saint Pierre	N/A
Takeda	Phase 1
UCB Biopharma SRL	Phase 3

See all ALPRAZOLAM clinical trials

Generic filers with tentative approvals for ALPRAZOLAM

Applicant	Application No.	Strength	Dosage Form
		1MG	TABLET;ORAL
		0.5MG	TABLET;ORAL
		0.25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALPRAZOLAM

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for ALPRAZOLAM

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Paragraph IV (Patent) Challenges for ALPRAZOLAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NIRAVAM	Orally Disintegrating Tablets	alprazolam	0.25 mg, 0.5 mg, 1 mg and 2 mg	021726	1	2005-12-27

US Patents and Regulatory Information for ALPRAZOLAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Oxford Pharms	ALPRAZOLAM	alprazolam	TABLET;ORAL	078491-003	Sep 25, 2008		DISCN	No	No
Amneal Pharms Ny	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	078387-001	May 30, 2008	AB	RX	No	No
Sun Pharm	ALPRAZOLAM	alprazolam	TABLET;ORAL	090082-004	Jun 17, 2010	AB	RX	No	No
Vintage Pharms	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	078442-004	Oct 15, 2007		DISCN	No	No
Natco	ALPRAZOLAM	alprazolam	TABLET;ORAL	200739-002	Apr 15, 2015	AB	RX	No	No
Watson Labs	ALPRAZOLAM	alprazolam	TABLET;ORAL	074456-003	Aug 31, 1995		DISCN	No	No
Mylan Pharms Inc	ALPRAZOLAM	alprazolam	TABLET;ORAL	074046-003	Oct 19, 1993		DISCN	No	No

Expired US Patents for ALPRAZOLAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-003	Jan 17, 2003
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-004	Jan 17, 2003
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-002	Approved Prior to Jan 1, 1982
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-001	Jan 19, 2005
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-003	Approved Prior to Jan 1, 1982
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-001	Jan 17, 2003
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-004	Jan 19, 2005