FOSAMAX Drug Patent Profile
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When do Fosamax patents expire, and when can generic versions of Fosamax launch?
Fosamax is a drug marketed by Merck, Organon, and Organon Llc. and is included in three NDAs.
The generic ingredient in FOSAMAX 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.
Summary for FOSAMAX
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 171 |
| Clinical Trials: | 62 |
| Patent Applications: | 3,619 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FOSAMAX |
| Drug Sales Revenues: | Drug sales revenues for FOSAMAX |
| What excipients (inactive ingredients) are in FOSAMAX? | FOSAMAX excipients list |
| DailyMed Link: | FOSAMAX at DailyMed |
Recent Clinical Trials for FOSAMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aristotle University Of Thessaloniki | Phase 4 |
| 424 General Military Hospital | Phase 4 |
| Yonsei University | Phase 4 |
Pharmacology for FOSAMAX
| Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for FOSAMAX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FOSAMAX | Oral Solution | alendronate sodium | 70 mg/75 mL | 021575 | 1 | 2007-09-07 |
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 Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | DISCN | 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 | ||||
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-001 | Sep 29, 1995 | DISCN | Yes | No | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck | FOSAMAX | alendronate sodium | SOLUTION;ORAL | 021575-001 | Sep 17, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck | FOSAMAX | alendronate sodium | SOLUTION;ORAL | 021575-001 | Sep 17, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Merck | FOSAMAX | alendronate sodium | SOLUTION;ORAL | 021575-001 | Sep 17, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOSAMAX
See the table below for patents covering FOSAMAX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1554349 | ⤷ Try a Trial | |
| South Korea | 20030097611 | ⤷ Try a Trial | |
| Greece | 3034936 | ⤷ Try a Trial | |
| United Kingdom | 2118042 | PHARMACEUTICAL COMPOSITIONS CONTAINING BIPHOSPHONIC ACIDS | ⤷ Try a Trial |
| Czech Republic | 285860 | Farmaceutický prostředek (PHARMACEUTICAL PREPARATION) | ⤷ Try a Trial |
| Hungary | 0004653 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSAMAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | C01175904/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: SCHERING CORPORATION, US |
| 0998292 | CA 2006 00005 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
| 1175904 | 91364 | Luxembourg | ⤷ Try a Trial | 91364, EXPIRES: 20200826 |
| 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 |
| 1175904 | 2007C/048 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 1175904 | CA 2007 00045 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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