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Last Updated: March 28, 2024

FOSAMAX PLUS D Drug Patent Profile


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When do Fosamax Plus D patents expire, and what generic alternatives are available?

Fosamax Plus D is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in FOSAMAX PLUS D is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Drug patent expirations by year for FOSAMAX PLUS D
Drug Prices for FOSAMAX PLUS D

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Recent Clinical Trials for FOSAMAX PLUS D

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

SponsorPhase
Aristotle University Of ThessalonikiPhase 4
424 General Military HospitalPhase 4
Yonsei UniversityPhase 4

See all FOSAMAX PLUS D clinical trials

Pharmacology for FOSAMAX PLUS D
Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOSAMAX PLUS D Tablets alendronate sodium; cholecalciferol 70 mg/2800 IU and 70 mg/5600 IU 021762 1 2007-11-20

US Patents and Regulatory Information for FOSAMAX PLUS D

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 FOSAMAX PLUS D

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FOSAMAX PLUS D

See the table below for patents covering FOSAMAX PLUS D around the world.

Country Patent Number Title Estimated Expiration
South Korea 20030097611 ⤷  Try a Trial
Austria 196736 ⤷  Try a Trial
Spain 2164447 ⤷  Try a Trial
Romania 113429 COMPOZITIE MEDICAMENTOASA PENTRU PREVENIREA SI TRATAREA BOLILOR CARE IMPLICA RESORBTIE OSOASA SI PROCEDEU DE OBTINERE A ACESTEIA (PHARMACEUTICAL COMPOSITION FOR PREVENTING AND TREATING DISEASES INVOLVING BONE RESORPTION AND PROCESS FOR PREPARING THE SAME) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 CA 2007 00045 Denmark ⤷  Try a Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
0998292 91222 Luxembourg ⤷  Try a Trial 91222, EXPIRES: 20200824
0998292 PA2006002 Lithuania ⤷  Try a Trial PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
1175904 PA2007007 Lithuania ⤷  Try a Trial PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
>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.