Fosamax Plus D is a drug owned by Organon Llc. It is protected by 8 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 17, 2019. Details of Fosamax Plus D's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US5994329 (Pediatric) | Method for inhibiting bone resorption |
Jan, 2019
(5 years ago) |
Expired
|
| US5994329 | Method for inhibiting bone resorption |
Jul, 2018
(6 years ago) |
Expired
|
|
US6090410 (Pediatric) | Dry mix formulation for bisphosphonic acids |
Jun, 2013
(11 years ago) |
Expired
|
|
US5358941 (Pediatric) | Dry mix formulation for bisphosphonic acids with lactose |
Jun, 2013
(11 years ago) |
Expired
|
|
US5681590 (Pediatric) | Dry mix formulation for bisphosphonic acids |
Jun, 2013
(11 years ago) |
Expired
|
| US5681590 | Dry mix formulation for bisphosphonic acids |
Dec, 2012
(11 years ago) |
Expired
|
| US5358941 | Dry mix formulation for bisphosphonic acids with lactose |
Dec, 2012
(11 years ago) |
Expired
|
| US6090410 | Dry mix formulation for bisphosphonic acids |
Dec, 2012
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Fosamax Plus D is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Fosamax Plus D's family patents as well as insights into ongoing legal events on those patents.
Fosamax Plus D's Family Patents
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Generic Launch
Generic Release Date:
Fosamax Plus D's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 17, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fosamax Plus D Generics:
There are no approved generic versions for Fosamax Plus D as of now.
How can I launch a generic of Fosamax Plus D before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fosamax Plus D's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fosamax Plus D's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Fosamax Plus D -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 70 mg/2800 IU and 70 mg/5600 IU | 20 Nov, 2007 | 1 | 17 Jul, 2018 | Extinguished |
About Fosamax Plus D
Fosamax Plus D is a drug owned by Organon Llc. It is used for improving bone mass and treating osteoporosis in postmenopausal women and men. Fosamax Plus D uses Alendronate Sodium; Cholecalciferol as an active ingredient. Fosamax Plus D was launched by Organon Llc in 2005.
Approval Date:
Fosamax Plus D was approved by FDA for market use on 07 April, 2005.
Active Ingredient:
Fosamax Plus D uses Alendronate Sodium; Cholecalciferol as the active ingredient. Check out other Drugs and Companies using Alendronate Sodium; Cholecalciferol ingredient
Treatment:
Fosamax Plus D is used for improving bone mass and treating osteoporosis in postmenopausal women and men.
Dosage:
Fosamax Plus D is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 70MG BASE;2,800 IU | TABLET | Prescription | ORAL |
| EQ 70MG BASE;5,600 IU | TABLET | Prescription | ORAL |