ALENDRONATE SODIUM; CHOLECALCIFEROL - Generic Drug Details
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What are the generic drug sources for alendronate sodium; cholecalciferol and what is the scope of freedom to operate?
Alendronate sodium; cholecalciferol
is the generic ingredient in one branded drug marketed by Organon Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for ALENDRONATE SODIUM; CHOLECALCIFEROL
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 1 |
DailyMed Link: | ALENDRONATE SODIUM; CHOLECALCIFEROL at DailyMed |
Recent Clinical Trials for ALENDRONATE SODIUM; CHOLECALCIFEROL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Hospital Medical Center, Cincinnati | Phase 2 |
Pharmacology for ALENDRONATE SODIUM; CHOLECALCIFEROL
Drug Class | Bisphosphonate Vitamin D |
Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM; CHOLECALCIFEROL
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 ALENDRONATE SODIUM; CHOLECALCIFEROL
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 | 021762-002 | Apr 26, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | RX | Yes | No | ⤷ 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 ALENDRONATE SODIUM; CHOLECALCIFEROL
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 |
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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