ALPRAZOLAM Drug Patent Profile
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When do Alprazolam patents expire, and what generic alternatives are available?
Alprazolam is a drug 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, Par Pharm, 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-six NDAs.
The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alprazolam
A generic version of ALPRAZOLAM was approved as alprazolam by NOVITIUM PHARMA on October 19th, 1993.
Summary for ALPRAZOLAM
| US Patents: | 0 |
| Applicants: | 26 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 27 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 95 |
| Patent Applications: | 3,997 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | ALPRAZOLAM | alprazolam | TABLET;ORAL | 074085-002 | Feb 16, 1994 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Natco | ALPRAZOLAM | alprazolam | TABLET;ORAL | 200739-003 | Apr 15, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Impax Labs | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 077968-002 | May 24, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 090871-002 | Jun 7, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Breckenridge | ALPRAZOLAM | alprazolam | TABLET;ORAL | 207507-004 | Jul 9, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | ALPRAZOLAM | alprazolam | TABLET;ORAL | 074112-001 | Dec 29, 1995 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 077391-004 | Jan 26, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
