ALPRAZOLAM - Generic Drug Details

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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, Ani Pharms, Apotex Inc, Aurobindo Pharma, Endo Operations, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Norvium Bioscience, Sandoz Inc, Upjohn, Ucb Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, 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-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALPRAZOLAM

US Patents:	0
Tradenames:	4
Applicants:	26
NDAs:	39
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	96
Patent Applications:	7,237
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

Drug Sales Revenue Trends 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
⤷ Sign Up	⤷ Sign Up	1MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	0.5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for ALPRAZOLAM

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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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
Sandoz	ALPRAZOLAM	alprazolam	TABLET;ORAL	074112-002	Dec 29, 1995	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Elizabeth	ALPRAZOLAM	alprazolam	TABLET;ORAL	074342-004	Oct 31, 1993	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-004	Nov 27, 1985	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	ALPRAZOLAM	alprazolam	TABLET;ORAL	090248-003	Sep 17, 2010	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

Expired US Patents for ALPRAZOLAM

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

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