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Last Updated: November 21, 2024

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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Drug patent expirations by year for ALENDRONATE SODIUM
Drug Prices for ALENDRONATE SODIUM

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Drug Sales Revenue Trends for ALENDRONATE SODIUM

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Recent Clinical Trials for ALENDRONATE SODIUM

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SponsorPhase
University of California, DavisPhase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 2
Doris Duke Charitable FoundationPhase 2

See all ALENDRONATE SODIUM clinical trials

Pharmacology for ALENDRONATE SODIUM
Drug ClassBisphosphonate
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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