ALENDRONATE SODIUM Drug Patent Profile
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Which patents cover Alendronate Sodium, and when can generic versions of Alendronate Sodium launch?
Alendronate Sodium is a drug marketed by Hikma, Novitium Pharma, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Ipca Labs Ltd, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, and Watson Labs. and is included in sixteen NDAs.
The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alendronate Sodium
A generic version of ALENDRONATE SODIUM was approved as alendronate sodium by APOTEX on August 4th, 2008.
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Summary for ALENDRONATE SODIUM
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 39 |
| Patent Applications: | 82 |
| Drug Prices: | Drug price information for ALENDRONATE SODIUM |
| Drug Sales Revenues: | Drug sales revenues for ALENDRONATE SODIUM |
| DailyMed Link: | ALENDRONATE SODIUM at DailyMed |
See drug prices for ALENDRONATE SODIUM
Recent Clinical Trials for ALENDRONATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Davis | Phase 2 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
| Doris Duke Charitable Foundation | Phase 2 |
Pharmacology for ALENDRONATE SODIUM
| Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for ALENDRONATE SODIUM
Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FOSAMAX | Oral Solution | alendronate sodium | 70 mg/75 mL | 021575 | 1 | 2007-09-07 |
US Patents and Regulatory Information for ALENDRONATE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 078638-001 | Aug 4, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-005 | Feb 6, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090022-003 | Sep 10, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076584-003 | Aug 4, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090022-004 | Sep 10, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076984-003 | Aug 4, 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 |
