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Last Updated: November 12, 2019

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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 West-ward Pharms Int, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Anchen Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Pharmacia And Upjohn, Par Pharm, Ucb Inc, Breckenridge, Dava Intl Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Oxford Pharms, Sandoz, 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. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for alprazolam

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Drug Sales Revenue Trends for alprazolam

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Recent Clinical Trials for alprazolam

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

SponsorPhase
University of Illinois at ChicagoPhase 1
Oregon State UniversityPhase 1
Naurex, Inc, an affiliate of Allergan plcPhase 1

See all alprazolam clinical trials

Recent Litigation for alprazolam

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
CIMA Labs Inc. v. Barr Laboratories Inc.2008-08-21
Plaintiff(s) v. Defendant(s)2008-01-31

See all alprazolam litigation

Generic filers with tentative approvals for ALPRAZOLAM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MGTABLET;ORAL
  Start Trial  Start Trial0.5MGTABLET;ORAL
  Start Trial  Start Trial0.25MGTABLET;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 ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for alprazolam
Synonyms for alprazolam
(Z)-8-chloro-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine
08H
12-chloro-3-methyl-9-phenyl-2,4,5,8-tetraazatricyclo[8.4.0.0;{2,6}]tetradeca-1(10),3,5,8,11,13-hexaene
28981-97-7
3u5j
4H-(1,2,4)Triazolo(4,3-a)(1,4)benzodiazepine, 8-chloro-1-methyl-6-phenyl-
4H-(1,2,4)Triazolo(4,3-alpha)(1,4)benzodiazepine, 8-chloro-1-methyl-6-phenyl-
4H-[1,2,4]Triazolo[4,3-a][1,4]benzodiazepine, 8-chloro-1-methyl-6-phenyl-
4H-[1,2,4]Triazolo[4,3-a][1,4]benzodiazepine,8-chloro-1-methyl-6-phenyl-
4H-s-Triazolo(4,3-a)(1,4)benzodiazepine, 8-chloro-1-methyl-6-phenyl-
51339-48-1
8-chloranyl-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine
8-Chloro-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine
8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-a] [1,4] benzodiazepine
8-chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-a][1,4] benzodiazepine
8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-a)(1,4)benzodiazepine
8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-alpha)(1,4)benzodiazepine
8-Chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine
8-chloro-6-phenyl-1-methyl-4H-s-triazolo-[4,3-a][1,4]benzodiazepine
981A977
A819702
AC-18721
AC1L1CYL
ACN-036616
AKOS005066050
Alcelam
Algad
Alpaz
Alplax
Alpram
Alprax
Alprazolam (JP17/USP/INN)
Alprazolam [USAN:INN:BAN:JAN]
Alprazolam [USAN:USP:INN:BAN:JAN]
Alprazolam 0.1 mg/ml in Methanol
Alprazolam 1.0 mg/ml in Methanol
Alprazolam extended release tablets
Alprazolam intensol
Alprazolam solution, 1 mg/mL in methanol, analytical standard, for drug analysis
Alprazolam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Alprazolam, European Pharmacopoeia (EP) Reference Standard
Alprazolamum
Alprazolamum [INN-Latin]
Alprazolan
Alpronax
Alprox
Alviz
Alzam
Alzolam
Alzon
Anpress
AP-1002
API0001427
Apo-Alpraz
AZ-002
Azor
BBL028160
BC226242
BDBM50001728
Bestrol
BIDD:GT0475
BIDD:PXR0150
BRD-K32398298-001-01-4
BRN 1223125
C06817
CAS-28981-97-7
Cassadan
CCG-100855
CHEBI:2611
CHEMBL661
Constan
CPD000149316
D 65MT
D-65MT
D00225
DB00404
DEA No. 2882
DSSTox_CID_2577
DSSTox_GSID_22577
DSSTox_RID_76639
DTXSID4022577
EINECS 249-349-2
Esparon
Frontal
FT-0658560
Gen-Alprazolan
GTPL7111
Helex
HMS2051A10
HMS3393A10
HSDB 7207
I14-7472
Intensol
Ksalol
LS-156344
MCULE-1215564244
Mialin
MLS000559000
MLS000759485
MLS001423979
NC00105
NCGC00159466-02
NCGC00159466-03
Neurol
Niravam
Novo-Alprazol
NSC-760140
NSC760140
Nu-Alpraz
Panistat
Panix
Pharmakon1600-01502395
Pharnax
Prazam
Prazolan
Prinox
Ralozam
Relaxol
Restyl
SAM001246696
SCHEMBL8398
SMR000149316
Solanax
Staccato-alprazolam
STK590494
Tafil
Tafil D
Tensivan
TGAR01P
Tox21_111692
Tranax
Trankimazin
Tranquinal
Tricalma
Tus 1
TUS-1
U 31889
U-31,889
U-31889
UNII-YU55MQ3IZY
Unilan
Valeans
VREFGVBLTWBCJP-UHFFFAOYSA-N
W-107015
Xanagis
Xanax
Xanax (TN)
Xanax TS
Xanax XR
Xanolam
Xanor
YU55MQ3IZY
Zacetin
Zanapam
Zaxan
ZB000199
Zenax
ZINC903
Zolam
Zolan
Zolarem
Zoldac
Zoldax
Zopax
Zopic
Zotran
Paragraph IV (Patent) Challenges for ALPRAZOLAM
Tradename Dosage Ingredient NDA Submissiondate
NIRAVAM TABLET, ORALLY DISINTEGRATING;ORAL alprazolam 021726 2005-12-27
XANAX TABLET;ORAL alprazolam 018276

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
Actavis Labs Fl Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077198-003 May 13, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077996-002 Jan 31, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ALPRAZOLAM alprazolam TABLET;ORAL 074085-003 Feb 16, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms ALPRAZOLAM alprazolam TABLET;ORAL 090248-002 Sep 17, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Ny ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078387-001 May 30, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc ALPRAZOLAM alprazolam TABLET;ORAL 077741-001 Jan 19, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc NIRAVAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 021726-002 Jan 19, 2005   Start Trial   Start Trial
Pharmacia And Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pharmacia And Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003   Start Trial   Start Trial
Pharmacia And Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985   Start Trial   Start Trial
Pharmacia And Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003   Start Trial   Start Trial
Pharmacia And Upjohn XANAX alprazolam TABLET;ORAL 018276-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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