Binosto Generic: When Will Generic Alendronate Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Binosto Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? February 2008 9 companies approved
- When does the last patent end? December 2031 Its only patent listed with the FDA
- Can you buy a generic today? Yes 23 companies list one
It already is. A generic alendronate sodium is listed for sale by 23 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Binosto, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Binosto by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2012 March 2012 FDA Orange Book
- Patents listed 1 last runs to December 2031 FDA Orange Book
- Generics FDA-approved 9 companies, the first approved February 2008 FDA Orange Book
- Pharmacies pay $71.23 per tablet NADAC, October 2026
- Medicare Part D spent $457.1K in 2025, for 276 people CMS Part D Spending by Drug
Binosto’s Road to a Generic
Binosto has had the market to itself since the FDA approved it in March 2012 (Radius Health Inc). Its one listed patent runs to December 2031.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Binosto Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Binosto’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,592,195 | The product’s formulation | December 2031 | Active |
Source: FDA Orange Book, application 202344. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Alendronate Sodium
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Binosto, but the FDA has already approved 9 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 9 companies, the first in February 2008. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic alendronate sodium is listed for sale by 23 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Amneal Pharmaceuticals of New York LLC, ANI Pharmaceuticals, Inc., Aurobindo Pharma Limited, Bryant Ranch Prepack, Cipla USA Inc. and 17 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Aurobindo Pharma Ltd | August 2008 | EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE | AB |
| Cipla Ltd | August 2008 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE | AB |
| Watson Laboratories Inc | August 2008 | EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE | AB |
| Sun Pharmaceutical Industries Ltd | September 2008 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE | AB |
| Hangzhou Minsheng Binjiang Pharmaceutical Co Ltd | September 2009 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE | AB |
| Hikma Pharmaceuticals USA Inc | February 2013 | EQ 70MG BASE/75ML | AA |
| Novitium Pharma LLC | May 2023 | EQ 70MG BASE/75ML | AA |
| Ipca Laboratories Ltd | June 2024 | EQ 10MG BASE, EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE | AB |
| Precision Dose Inc | September 2026 | EQ 70MG BASE/75ML | AA |
| Impax Laboratories Inc discontinued | February 2008 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE | – |
| Teva Pharmaceuticals USA discontinued | February 2008 | EQ 35MG BASE, EQ 70MG BASE | – |
| Apotex Inc discontinued | August 2008 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE | – |
| Chartwell Rx Sciences LLC discontinued | August 2008 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 40MG BASE, EQ 70MG BASE | – |
| Mylan Pharmaceuticals Inc discontinued | August 2008 | EQ 35MG BASE, EQ 70MG BASE | – |
| Rising Pharma Holding Inc discontinued | August 2008 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE | – |
| Jubilant Cadista Pharmaceuticals Inc discontinued | February 2010 | EQ 5MG BASE, EQ 10MG BASE, EQ 35MG BASE, EQ 70MG BASE | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Binosto Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Binosto 70 mg effervescent tab
$71.23 per tablet in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $71.23 |
| September 2026 | $71.23 |
| August 2026 | $71.64 |
| July 2026 | $71.64 |
| June 2026 | $71.64 |
| May 2026 | $71.64 |
| April 2026 | $71.85 |
| March 2026 | $71.85 |
| February 2026 | $71.85 |
| January 2026 | $71.85 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Binosto today: $71.23 per tablet for Binosto 70 mg effervescent tab in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Dollar figures apply FDA’s median drops to the $71.23 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Binosto
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Binosto, before manufacturer rebates.
- $125.1K
- January to March 2026, the latest CMS has posted
For 177 people, about $409 per prescription fill - $457.1K
- 2025, the whole year
For 276 people, about $425 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $125,101 | 177 | $408.83 |
| 2025 | $457,134 | 276 | $424.85 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Binosto only, so no generic is counted in it. What CMS says it is used for: Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.
Binosto Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 70MG BASE | Tablet, effervescent | Oral | March 2012 | Discontinued reference product |
Source: FDA Orange Book, Radius Health Inc. Listed for sale today by ASCEND Therapeutics U.S., LLC, ASCEND Therapeutics and Radius Health, Inc. (FDA NDC Directory).
Binosto NDC Codes and Packages
Each Binosto package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 17139-0400-01 | 70 mg tablet, effervescent | carton of 1 tablet | ASCEND Therapeutics |
| 17139-0400-04 | 70 mg tablet, effervescent | carton of 4 tablets | ASCEND Therapeutics |
| 70539-0400-04 | ALENDRONATE SODIUM 91.37 mg/1 tablet, effervescent | box of 4 blister packs of 1 tablet | Radius Health, Inc. |
| 70539-0400-04 | ALENDRONATE SODIUM 91.37 mg/1 tablet, effervescent | box of 4 blister packs of 1 tablet | Radius Health, Inc. |
| 70539-0400-94 | ALENDRONATE SODIUM 91.37 mg/1 tablet, effervescent | box of 4 blister packs of 1 tablet | Radius Health, Inc. |
| 70539-0400-94 | ALENDRONATE SODIUM 91.37 mg/1 tablet, effervescent | box of 4 blister packs of 1 tablet | Radius Health, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Binosto’s own FDA approval (NDA 202344) are listed, never a generic. Some codes belong to companies that repackage Binosto: it is the same medicine in a different package.
What a Generic Binosto Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Binosto
Is there a generic for Binosto right now?
Yes. The FDA NDC Directory lists a generic alendronate sodium from 23 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Binosto go generic?
It already has. The FDA NDC Directory lists a generic alendronate sodium from 23 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic alendronate sodium be the same as Binosto?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved 9 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Binosto?
Yes. The FDA Orange Book lists approved generic versions from 9 companies, the first approved in February 2008: Aurobindo Pharma Ltd, Cipla Ltd, Watson Laboratories Inc, Sun Pharmaceutical Industries Ltd and 5 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Binosto patent expire?
One patent is listed for Binosto in the FDA Orange Book; it runs to December 2031. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (a date that is not known yet) weighs all of that.
How much does Binosto cost now?
Pharmacies paid about $71.23 per tablet for Binosto 70 mg effervescent tab in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected a date that is not known yet on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- AkliefTrifarotene2031 to 2032
- InrebicFedratinib Hydrochloride2033 to 2034
- RyteloImetelstat2036 to 2037
- DextenzaDexamethasoneNovember 2037
- Norepinephrine Bitartrate in Sodium ChlorideNorepinephrine BitartrateJanuary 2038
- VeregenSinecatechinsTBD no date yet
About Binosto
- Generic name alendronate sodium
- How it is taken By mouth
- Company Radius Health Inc
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Binosto
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, FDA NDC Directory, NADAC (CMS), CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.