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Serving leading biopharmaceutical companies globally:

US Army
Fuji
Federal Trade Commission
Boehringer Ingelheim
Johnson and Johnson
McKinsey
Covington
Moodys
Farmers Insurance
McKesson

Generated: January 21, 2018

DrugPatentWatch Database Preview

FOSAMAX PLUS D Drug 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 Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in forty countries.

The generic ingredient in FOSAMAX PLUS D is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. Two suppliers are listed 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
Pharmacology for FOSAMAX PLUS D

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
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Expired US Patents for FOSAMAX PLUS D

Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 11/20/2007

Non-Orange Book US Patents for FOSAMAX PLUS D

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,465,443 Method for inhibiting bone resorption ➤ Subscribe
6,015,801 Method for inhibiting bone resorption ➤ Subscribe
6,225,294 Method for inhibiting bone resorption ➤ Subscribe
6,544,967 Method for inhibiting bone resorption ➤ Subscribe
6,432,932 Method for inhibiting bone resorption ➤ Subscribe
6,333,316 Method for inhibiting bone resorption ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for FOSAMAX PLUS D

Supplementary Protection Certificates for FOSAMAX PLUS D

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00292 Netherlands ➤ Subscribe 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
2006 00005 Denmark ➤ Subscribe
364 Luxembourg ➤ Subscribe 91364, EXPIRES: 20200826
2006002,C0998292 Lithuania ➤ Subscribe 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
2006002 Lithuania ➤ Subscribe 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
2007 00045 Denmark ➤ Subscribe
222 Luxembourg ➤ Subscribe 91222, EXPIRES: 20200824
2007007 Lithuania ➤ Subscribe 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
1175904/01 Switzerland ➤ Subscribe FORMER OWNER: SCHERING CORPORATION, US
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Federal Trade Commission
Chubb
US Department of Justice
Cantor Fitzgerald
US Army
Dow
Medtronic
Cerilliant

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 verifification 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.

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