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, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, and Watson Labs. and is included in fifteen NDAs.
The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty 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
![ALENDRONATE SODIUM drug patent expirations Drug patent expirations by year for ALENDRONATE SODIUM](/p/graph/s/t/ALENDRONATE_SODIUM-patent-expirations.png)
![Drug Prices for ALENDRONATE SODIUM](/p/graph/drug-price/ALENDRONATE+SODIUM.png)
See drug prices for ALENDRONATE SODIUM
![Drug Sales Revenue Trends for ALENDRONATE SODIUM](/p/graph/drug-sales-revenues/ALENDRONATE+SODIUM.png)
Recent Clinical Trials for ALENDRONATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Aristotle University Of Thessaloniki | Phase 4 |
424 General Military Hospital | Phase 4 |
Shanghai JMT-Bio Inc. | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rising | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076584-003 | 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 | ||||
Watson Labs | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076984-001 | Aug 4, 2008 | AB | RX | 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 | |||
Watson Labs | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076984-002 | 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 |