Fosamax is a drug owned by Merck And Co Inc. 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'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
|
|
US6015801 (Pediatric) | Method for inhibiting bone resorption |
Jan, 2019
(5 years ago) |
Expired
|
|
US6225294 (Pediatric) | Method for inhibiting bone resorption |
Jan, 2019
(5 years ago) |
Expired
|
| US6015801 | Method for inhibiting bone resorption |
Jul, 2018
(6 years ago) |
Expired
|
| US6225294 | Method for inhibiting bone resorption |
Jul, 2018
(6 years ago) |
Expired
|
| US5994329 | Method for inhibiting bone resorption |
Jul, 2018
(6 years ago) |
Expired
|
|
US5462932 (Pediatric) | Oral liquid alendronate formulations |
Nov, 2014
(10 years ago) |
Expired
|
| US5462932 | Oral liquid alendronate formulations |
May, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Fosamax 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's family patents as well as insights into ongoing legal events on those patents.
Fosamax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fosamax'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 Generic API suppliers:
Alendronate Sodium is the generic name for the brand Fosamax. 16 different companies have already filed for the generic of Fosamax, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fosamax's generic
How can I launch a generic of Fosamax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fosamax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fosamax'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 70 mg/75 mL | 07 Sep, 2007 | 1 | 17 Jul, 2018 | Extinguished | |
| 5 mg, 10 mg, 35 mg, 40 mg and 70 mg |
Alternative Brands for Fosamax
There are several other brand drugs using the same active ingredient (Alendronate Sodium) as Fosamax. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Organon Llc |
| |
| Radius |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Alendronate Sodium, Fosamax's active ingredient. Check the complete list of approved generic manufacturers for Fosamax
About Fosamax
Fosamax is a drug owned by Merck And Co Inc. Fosamax uses Alendronate Sodium as an active ingredient. Fosamax was launched by Merck in 2003.
Approval Date:
Fosamax was approved by FDA for market use on 17 September, 2003.
Active Ingredient:
Fosamax uses Alendronate Sodium as the active ingredient. Check out other Drugs and Companies using Alendronate Sodium ingredient
Dosage:
Fosamax is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |
Fosamax is a drug owned by Organon Llc A Sub Of Organon And Co. 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 Jun 02, 2013. Details of Fosamax'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). | |||
|
US6090410 (Pediatric) | Dry mix formulation for bisphosphonic acids |
Jun, 2013
(11 years ago) |
Expired
|
|
US5681590 (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
|
|
US6194004 (Pediatric) | Dry mix formulation for bisphosphonic acids |
Jun, 2013
(11 years ago) |
Expired
|
| US6194004 | Dry mix formulation for bisphosphonic acids |
Dec, 2012
(12 years ago) |
Expired
|
| US6090410 | Dry mix formulation for bisphosphonic acids |
Dec, 2012
(12 years ago) |
Expired
|
| US5358941 | Dry mix formulation for bisphosphonic acids with lactose |
Dec, 2012
(12 years ago) |
Expired
|
| US5681590 | Dry mix formulation for bisphosphonic acids |
Dec, 2012
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Fosamax 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's family patents as well as insights into ongoing legal events on those patents.
Fosamax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fosamax's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 02, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fosamax Generic API suppliers:
Alendronate Sodium is the generic name for the brand Fosamax. 16 different companies have already filed for the generic of Fosamax, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fosamax's generic
How can I launch a generic of Fosamax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fosamax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fosamax'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 70 mg/75 mL | 07 Sep, 2007 | 1 | 17 Jul, 2018 | Extinguished | |
| 5 mg, 10 mg, 35 mg, 40 mg and 70 mg |
Alternative Brands for Fosamax
There are several other brand drugs using the same active ingredient (Alendronate Sodium) as Fosamax. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Organon Llc |
| |
| Radius |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Alendronate Sodium, Fosamax's active ingredient. Check the complete list of approved generic manufacturers for Fosamax
About Fosamax
Fosamax is a drug owned by Organon Llc A Sub Of Organon And Co. Fosamax uses Alendronate Sodium as an active ingredient. Fosamax was launched by Organon in 1997.
Approval Date:
Fosamax was approved by FDA for market use on 25 April, 1997.
Active Ingredient:
Fosamax uses Alendronate Sodium as the active ingredient. Check out other Drugs and Companies using Alendronate Sodium ingredient
Dosage:
Fosamax is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 70MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |