Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Citi
Federal Trade Commission
Merck
QuintilesIMS
McKesson
Dow
Johnson and Johnson
Cerilliant
Farmers Insurance
Mallinckrodt

Generated: February 22, 2018

DrugPatentWatch Database Preview

FOSAMAX Drug Profile

« Back to Dashboard

Which patents cover Fosamax, and when can generic versions of Fosamax launch?

Fosamax is a drug marketed by Merck and Merck And Co Inc and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in FOSAMAX 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.
Drug patent expirations by year for FOSAMAX
Pharmacology for FOSAMAX
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

US Patents and Regulatory Information for FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for FOSAMAX

Paragraph IV (Patent) Challenges for FOSAMAX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 11/20/2007
➤ Subscribe Oral Solution 70 mg/75 mL ➤ Subscribe 9/7/2007

Non-Orange Book US Patents for FOSAMAX

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
6,333,316 Method for inhibiting bone resorption ➤ Try a Free Trial
6,544,967 Method for inhibiting bone resorption ➤ Try a Free Trial
6,432,932 Method for inhibiting bone resorption ➤ Try a Free Trial
6,465,443 Method for inhibiting bone resorption ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for FOSAMAX

Supplementary Protection Certificates for FOSAMAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002,C0998292 Lithuania ➤ Try a Free 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
2006 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
2007 00045 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
364 Luxembourg ➤ Try a Free Trial 91364, EXPIRES: 20200826
2006002 Lithuania ➤ Try a Free 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
00292 Netherlands ➤ Try a Free 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
2007007 Lithuania ➤ Try a Free 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
222 Luxembourg ➤ Try a Free Trial 91222, EXPIRES: 20200824
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
Medtronic
AstraZeneca
Merck
Deloitte
Fish and Richardson
Healthtrust
Teva

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.

botpot