ALPRAZOLAM Drug Patent Profile
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Which patents cover Alprazolam, and when can generic versions of Alprazolam launch?
Alprazolam is a drug 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, 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-six NDAs.
The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Thirty-six 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.
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Questions you can ask:
- What is the 5 year forecast for ALPRAZOLAM?
- What are the global sales for ALPRAZOLAM?
- What is Average Wholesale Price for ALPRAZOLAM?
Summary for ALPRAZOLAM
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 96 |
| Patent Applications: | 4,468 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | ALPRAZOLAM | alprazolam | TABLET;ORAL | 074046-003 | Oct 19, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Heritage Pharms Inc | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078489-003 | Oct 17, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 078469-001 | Sep 29, 2011 | DISCN | 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 |
