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.
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Summary for FOSAMAX PLUS D
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 63 |
| Drug Prices: | Drug price information for FOSAMAX PLUS D |
| What excipients (inactive ingredients) are in FOSAMAX PLUS D? | FOSAMAX PLUS D excipients list |
| DailyMed Link: | FOSAMAX PLUS D at DailyMed |
Recent Clinical Trials for FOSAMAX PLUS D
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Doris Duke Charitable Foundation | Phase 2 |
| University of California, Davis | Phase 2 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
Pharmacology for FOSAMAX PLUS D
| Drug Class | Bisphosphonate Vitamin 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |
|---|---|---|---|
| Germany | 69837450 | ⤷ Sign Up | |
| European Patent Office | 0998292 | PROCEDE D'INHIBITION DE RESORPTION OSSEUSE (METHOD FOR INHIBITING BONE RESORPTION) | ⤷ Sign Up |
| Spain | 2164447 | ⤷ Sign Up | |
| Germany | 01201911 | ⤷ Sign Up | |
| Israel | 133535 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSAMAX PLUS D
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | C300292 | Netherlands | ⤷ Sign Up | 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 | C01175904/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: SCHERING CORPORATION, US |
| 0998292 | PA2006002 | Lithuania | ⤷ Sign Up | 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 | CA 2007 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
| 1175904 | 91364 | Luxembourg | ⤷ Sign Up | 91364, EXPIRES: 20200826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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