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Last Updated: November 22, 2024

ALENDRONATE SODIUM - Generic Drug Details


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What are the generic drug sources for alendronate sodium and what is the scope of freedom to operate?

Alendronate sodium is the generic ingredient in four branded drugs marketed by Hikma, Novitium Pharma, Merck, Radius, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Ipca Labs Ltd, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in twenty NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has twenty patent family members in sixteen countries.

There are eighteen drug master file entries for alendronate sodium. Twenty-two suppliers are listed for this compound.

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

Identify potential brand extensions & 505(b)(2) entrants

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
Aurobindo Pharma ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090124-003 Aug 4, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076584-002 Aug 4, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ipca Labs Ltd ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 206387-004 Jun 4, 2024 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
Hangzhou Binjiang ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090258-004 Sep 24, 2009 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

Expired US Patents for ALENDRONATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Sign Up ⤷  Sign Up
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ⤷  Sign Up ⤷  Sign Up
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Sign Up ⤷  Sign Up
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ⤷  Sign Up ⤷  Sign Up
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ALENDRONATE SODIUM

Country Patent Number Title Estimated Expiration
Spain 2716525 ⤷  Sign Up
Malaysia 166971 STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS ⤷  Sign Up
Poland 2648702 ⤷  Sign Up
South Korea 20180115254 신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) ⤷  Sign Up
South Korea 102011505 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALENDRONATE SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium ⤷  Sign Up PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.