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  2. ›drugs
  3. ›ALENDRONATE SODIUM
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ALENDRONATE SODIUM

Marketedupdated 3mo ago
by Ipca Pharmaceuticals Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 7
  • tagApproval220 co-mentions · 110 sources
  • drugFOSAMAX195 co-mentions · 110 sources
  • drugFOSAMAX PLUS D195 co-mentions · 110 sources
  • tagSmall Molecule110 co-mentions · 110 sources
  • drug(alendronate sodium + cholecalciferol)18 co-mentions · 18 sources
  • companyAurobindo Pharma Ltd15 co-mentions · 15 sources
  • companyNovitium Pharma LLC2 co-mentions · 2 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 2 investigational indications.

all catalysts(77)

approval · 77
Sep 29, 1995
approval
$OGN13.700.00%
31y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Oct 16, 1995
approval
$OGN13.700.00%
31y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Nov 21, 1996
approval
$OGN13.700.00%
30y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 3, 1996
approval
$OGN13.700.00%
30y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Mar 24, 1997
approval
$OGN13.700.00%
29y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Apr 25, 1997
approval
$OGN13.700.00%
29y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Apr 25, 1997
approval
$OGN13.700.00%
29y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jan 27, 1998
approval
$OGN13.700.00%
29y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
May 12, 1998
approval
$OGN13.700.00%
28y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Mar 19, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
May 28, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jun 8, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jun 16, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Oct 19, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Oct 19, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Nov 24, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Nov 24, 1999
approval
$OGN13.700.00%
27y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Sep 29, 2000
approval
$OGN13.700.00%
26y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Oct 20, 2000
approval
$OGN13.700.00%
26y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Oct 20, 2000
approval
$OGN13.700.00%
26y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jan 31, 2001
approval
$OGN13.700.00%
26y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jan 31, 2001
approval
$OGN13.700.00%
26y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jun 26, 2001
approval
$OGN13.700.00%
25y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Nov 27, 2001
approval
$OGN13.700.00%
25y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jul 25, 2002
approval
$OGN13.700.00%
24y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Aug 5, 2002
approval
$OGN13.700.00%
24y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Aug 13, 2002
approval
$OGN13.700.00%
24y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Sep 16, 2002
approval
$OGN13.700.00%
24y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Mar 24, 2003
approval
$OGN13.700.00%
23y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Sep 17, 2003
approval
$OGN13.700.00%
23y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Feb 20, 2004
approval
$OGN13.700.00%
23y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Apr 16, 2004
approval
$OGN13.700.00%
22y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Apr 27, 2004
approval
$OGN13.700.00%
22y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 1, 2004
approval
$OGN13.700.00%
22y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 1, 2004
approval
$OGN13.700.00%
22y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Nov 2, 2005
approval
$OGN13.700.00%
21y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 21, 2005
approval
$OGN13.700.00%
21y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 28, 2006
approval
$OGN13.700.00%
20y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 28, 2006
approval
$OGN13.700.00%
20y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Aug 4, 2008
approval
18y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Oct 8, 2008
approval
$OGN13.700.00%
18y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Feb 19, 2009
approval
18y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Mar 1, 2010
approval
$OGN13.700.00%
16y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Mar 1, 2010
approval
$OGN13.700.00%
16y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Mar 1, 2010
approval
$OGN13.700.00%
16y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Aug 24, 2010
approval
16y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jan 25, 2011
approval
$OGN13.700.00%
16y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Feb 15, 2011
approval
16y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Apr 6, 2011
approval
15y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jul 1, 2011
approval
$OGN13.700.00%
15y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Feb 6, 2012
approval
$OGN13.700.00%
15y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
May 17, 2012
approval
14y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jun 25, 2012
approval
14y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jun 27, 2012
approval
$OGN13.700.00%
14y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Feb 5, 2013
approval
14y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Feb 25, 2013
approval
13y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Apr 19, 2013
approval
$OGN13.700.00%
13y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Dec 23, 2013
approval
$OGN13.700.00%
13y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Apr 8, 2015
approval
$OGN13.700.00%
11y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jun 19, 2015
approval
$OGN13.700.00%
11y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Jul 22, 2015
approval
11y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jul 22, 2015
approval
11y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jul 22, 2015
approval
11y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Sep 23, 2015
approval
11y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Nov 30, 2015
approval
$OGN13.700.00%
11y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Apr 8, 2016
approval
10y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Aug 16, 2019
approval
$OGN13.700.00%
7y ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Aug 19, 2019
approval
7y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
May 11, 2023
approval
3y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jun 6, 2023
approval
3y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Sep 27, 2024
approval
2y ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jan 28, 2026
approval
7mo ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Jan 28, 2026
approval
7mo ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Feb 3, 2026
approval
$OGN13.700.00%
7mo ago
FOSAMAX (ALENDRONATE SODIUM) — FDA approval
ALENDRONATE SODIUM
→
Feb 3, 2026
approval
7mo ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Feb 3, 2026
approval
7mo ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
Apr 15, 2026
approval
4mo ago
ALENDRONATE SODIUM — FDA approval
ALENDRONATE SODIUM
→
view all 77 catalysts →

Trials studying ALENDRONATE SODIUM

  • phase3A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)completedn=454
  • phase3A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)completedn=936
  • phase3A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)completedn=717
  • phase3A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)completedn=515
  • phase4Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)completedn=343
  • phase3Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)completedn=200

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 5, 2031
~5.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (1)

  • Dec 5, 2031formulationUS 9592195

News(0)

no news has mentioned this drug yet

brand
ALENDRONATE SODIUM
generic
ALENDRONATE SODIUM
MOA
12.1 Mechanism of Action Alendronate Sodium Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [ 3 H]alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ 3 H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass. Cholecalciferol Vitamin D 3 is produced in the skin by photochemical conversion of 7-dehydrocholesterol to previtamin D 3 by ultraviolet light. This is followed by non-enzymatic isomerization to vitamin D 3 . In the absence of adequate sunlight exposure, vitamin D 3 is an essential dietary nutrient. Vitamin D 3 in skin and dietary vitamin D 3 (absorbed into chylomicrons) is converted to 25-hydroxyvitamin D 3 in the liver. Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D 3 (calcitriol) in the kidney is stimulated by both parathyroid hormone and hypophosphatemia. The principal action of 1,25-dihydroxyvitamin D 3 is to increase intestinal absorption of both calcium an
indication
Glucocorticoid-Induced Osteoporosis
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 25m ago
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