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Last Updated: March 29, 2024

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. 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 C300292 Netherlands ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904 C01175904/01 Switzerland ⤷  Try a Trial FORMER OWNER: SCHERING CORPORATION, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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