GALANTAMINE HYDROBROMIDE Drug Patent Profile
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When do Galantamine Hydrobromide patents expire, and when can generic versions of Galantamine Hydrobromide launch?
Galantamine Hydrobromide is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Norvium Bioscience, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc. and is included in nineteen NDAs.
The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Galantamine Hydrobromide
A generic version of GALANTAMINE HYDROBROMIDE was approved as galantamine hydrobromide by BARR on August 28th, 2008.
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Questions you can ask:
- What is the 5 year forecast for GALANTAMINE HYDROBROMIDE?
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- What is Average Wholesale Price for GALANTAMINE HYDROBROMIDE?
Summary for GALANTAMINE HYDROBROMIDE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 100 |
| Clinical Trials: | 22 |
| Drug Prices: | Drug price information for GALANTAMINE HYDROBROMIDE |
| What excipients (inactive ingredients) are in GALANTAMINE HYDROBROMIDE? | GALANTAMINE HYDROBROMIDE excipients list |
| DailyMed Link: | GALANTAMINE HYDROBROMIDE at DailyMed |
Recent Clinical Trials for GALANTAMINE HYDROBROMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanderbilt University Medical Center | Phase 1 |
| Ortho-McNeil Neurologics, Inc. | Phase 4 |
| Duke University | Phase 4 |
Pharmacology for GALANTAMINE HYDROBROMIDE
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for GALANTAMINE HYDROBROMIDE
Anatomical Therapeutic Chemical (ATC) Classes for GALANTAMINE HYDROBROMIDE
Paragraph IV (Patent) Challenges for GALANTAMINE HYDROBROMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RAZADYNE ER | Extended-release Capsules | galantamine hydrobromide | 16 mg and 24 mg | 021615 | 1 | 2006-03-11 |
| RAZADYNE ER | Extended-release Capsules | galantamine hydrobromide | 8 mg | 021615 | 1 | 2006-03-02 |
| RAZADYNE | Tablets | galantamine hydrobromide | 4 mg, 8 mg and 12 mg | 021169 | 14 | 2005-02-28 |
US Patents and Regulatory Information for GALANTAMINE HYDROBROMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077590-001 | May 29, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Ltd | GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077593-001 | Sep 11, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077589-003 | Jun 22, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077603-002 | Aug 28, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Yabao Pharm | GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077604-001 | Feb 6, 2009 | AB | RX | No | Yes | ⤷ 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 |
