Alprazolam - Generic Drug Details
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What are the generic sources for alprazolam and what is the scope of patent protection?
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 |
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 |
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
Anatomical Therapeutic Chemical (ATC) Classes for alprazolam
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Amneal Pharms Ny | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078387-004 | May 30, 2008 | 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
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 |
Upjohn | XANAX | alprazolam | TABLET;ORAL | 018276-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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