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Last Updated: October 1, 2022

FOSAMAX PLUS D Drug Patent Profile


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When do Fosamax Plus D patents expire, and when can generic versions of Fosamax Plus D launch?

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. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Summary for FOSAMAX PLUS D
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
424 General Military HospitalPhase 4
Aristotle University Of ThessalonikiPhase 4
Yonsei UniversityPhase 4

See all FOSAMAX PLUS D clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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
Israel 153109 PHARMACEUTICAL COMPOSITION USEFUL FOR INHIBITING BONE RESORPTION IN A HUMAN COMPRISING ALENDRONIC ACID OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A MIXTURE THEREOF See Plans and Pricing
Taiwan I226833 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9412200 See Plans and Pricing
Portugal 998292 See Plans and Pricing
Poland 195272 See Plans and Pricing
Japan 2002502433 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0998292 PA2006002 Lithuania See Plans and Pricing 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 91364 Luxembourg See Plans and Pricing 91364, EXPIRES: 20200826
1175904 CA 2007 00045 Denmark See Plans and Pricing PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
1175904 C300292 Netherlands See Plans and Pricing PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
0998292 CA 2006 00005 Denmark See Plans and Pricing PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904 PA2007007 Lithuania See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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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.