Clindesse Generic: When Will Generic Clindamycin 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
Clindesse 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 1982 22 companies approved
- When does the last patent end? December 2026 Its only patent listed with the FDA
- Can you buy a generic today? Yes 40 companies list one in some form
A generic clindamycin phosphate is already listed for sale in some form by 40 companies, so ask your pharmacy whether one matches Clindesse.
Will the generic cost less?
Usually, and more so as more companies sell one. At least 22 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $26.62 pharmacies pay per gram for Clindesse today to under $1.33. See the price estimate
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Clindesse, 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.
Clindesse by the Numbers
- Reason
- Awaiting FDA approvalThe patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $2M a yearSmaller seller
- FDA approved 2004 November 2004 FDA Orange Book
- Patents listed 1 last runs to December 2026 FDA Orange Book
- Generics FDA-approved 22 companies, the first approved February 1982 FDA Orange Book
- Pharmacies pay $26.62 per gram, down 1.3% in a year NADAC, October 2026
- Medicare Part D spent $37.8K in 2025, for 132 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,626 in the last four reported quarters, $344.6K CMS Medicaid drug utilization, to Q1 2026
Clindesse’s Road to a Generic
Clindesse has had the market to itself since the FDA approved it in November 2004 (Padagis US LLC). Its one listed patent runs to December 2026. Generic companies have challenged its patents with the FDA since February 2015.
The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
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.
Clindesse Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Clindesse’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 |
|---|---|---|---|
| 9,789,057 | The product’s formulation; a way of using it (U-137) | December 2026 | Active |
Source: FDA Orange Book, application 050793. Patent numbers open the patent on Google Patents.
Patent Challenges to Clindesse
The first patent challenge to Clindesse reached the FDA in February 2015, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Clindesse’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Vaginal cream, 0.02 | February 2015 | 1 company | Head start no longer applies decided April 2020 | Not yet | Not yet | April 2023 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Clindamycin Phosphate
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
At least 22 companies have applied to the FDA to make generic clindamycin phosphate.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Clindesse’s patents with the FDA since February 2015: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 22 companies, the first in February 1982. 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 clindamycin phosphate in some form is listed for sale by 40 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Akorn, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Amneal Pharmaceuticals NY LLC, Aurobindo Pharma Limited and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | October 1987 | EQ 6MG BASE/ML, EQ 12MG BASE/ML, EQ 18MG BASE/ML, EQ 150MG BASE/ML | AP |
| Pfizer Inc | October 1987 | EQ 150MG BASE/ML | AP |
| Padagis US LLC | September 1992 | EQ 1% BASE | AT |
| Fougera Pharmaceuticals Inc | June 1997 | EQ 1% BASE, EQ 2% BASE | AB, AB1, AT |
| Taro Pharmaceutical Industries Ltd | March 2004 | 1%, EQ 1% BASE | AT |
| Padagis Israel Pharmaceuticals Ltd | March 2010 | 1%, EQ 1% BASE | AT, AB1, AB |
| Epic Pharma LLC | June 2010 | EQ 1% BASE | AT |
| Sagent Pharmaceuticals Inc | September 2011 | EQ 150MG BASE/ML | AP |
| Sandoz Inc | May 2012 | EQ 6MG BASE/ML, EQ 12MG BASE/ML, EQ 18MG BASE/ML | AP |
| Rising Pharma Holdings Inc | April 2013 | EQ 1% BASE, EQ 6MG BASE/ML, EQ 12MG BASE/ML, EQ 18MG BASE/ML | AP, AT |
| Baxter Healthcare Corp | June 2017 | EQ 6MG BASE/ML, EQ 12MG BASE/ML, EQ 18MG BASE/ML | AP |
| Chartwell Rx Sciences LLC | February 2018 | EQ 1% BASE | AT |
| Zydus Lifesciences Ltd | July 2018 | EQ 1% BASE | AB1, AT |
| Encube Ethicals Pvt Ltd | January 2019 | EQ 1% BASE | AT |
| Solaris Pharma Corp | July 2020 | EQ 1% BASE | AB1, AB2 |
| Sun Pharma Canada Inc | November 2020 | EQ 1% BASE | AB1, AB |
| Glenmark Pharmaceuticals Ltd | February 2021 | 1%, EQ 1% BASE | AT, AB1 |
| Encube Ethicals Private Ltd | March 2021 | EQ 1% BASE | AB1, AB |
| Amneal Pharmaceuticals LLC | August 2022 | EQ 1% BASE | AB2 |
| Alembic Pharmaceuticals Ltd | April 2024 | EQ 1% BASE | AB1 |
| Carnegie Pharmaceuticals LLC | June 2025 | EQ 1% BASE | AT |
| Aurobindo Pharma Ltd | March 2026 | EQ 1% BASE | AB1 |
| Pharmacia And Upjohn Co discontinued | February 1982 | EQ 1% BASE, EQ 150MG BASE/ML | – |
| Almaject Inc discontinued | July 1987 | EQ 150MG BASE/ML | – |
| Solopak Laboratories Inc discontinued | March 1988 | EQ 150MG BASE/ML | – |
| Loch Pharmaceuticals Inc discontinued | May 1988 | EQ 150MG BASE/ML | – |
| Abraxis Pharmaceutical Products discontinued | June 1988 | EQ 150MG BASE/ML | – |
| Watson Laboratories Inc discontinued | June 1988 | EQ 150MG BASE/ML | – |
| G And W Laboratories Inc discontinued | September 1988 | EQ 1% BASE | – |
| Marsam Pharmaceuticals LLC discontinued | October 1988 | EQ 150MG BASE/ML | – |
| Boca Pharmacal LLC discontinued | January 1989 | EQ 1% BASE | – |
| Bristol Myers Squibb Pharma Co discontinued | February 1989 | EQ 150MG BASE/ML | – |
| Igi Laboratories Inc discontinued | February 1989 | EQ 150MG BASE/ML | – |
| Vintage Pharmaceuticals discontinued | June 1989 | EQ 1% BASE | – |
| Teva Parenteral Medicines Inc discontinued | December 1989 | EQ 150MG BASE/ML | – |
| Bedford Laboratories Div Ben Venue Laboratories Inc discontinued | June 1994 | EQ 150MG BASE/ML | – |
| Ingenus Pharmaceuticals LLC discontinued | September 1996 | EQ 1% BASE | – |
| Perrigo Co Of Tenessee Inc discontinued | September 1996 | EQ 1% BASE | – |
| Xttrium Laboratories Inc discontinued | July 1997 | EQ 1% BASE | – |
| Abbott Laboratories discontinued | June 2001 | EQ 6MG BASE/ML, EQ 12MG BASE/ML, EQ 18MG BASE/ML | – |
| Fresenius Kabi USA LLC discontinued | March 2007 | EQ 150MG BASE/ML | – |
| Ph Health Ltd discontinued | May 2015 | EQ 1% BASE | – |
| Pai Holdings LLC Dba Pharmaceutical Associates Inc discontinued | December 2016 | EQ 1% BASE | – |
| Rising Pharma Holding Inc discontinued | October 2017 | EQ 150MG BASE/ML | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Clindesse Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Clindesse 2% vaginal cream
$26.62 per gram in October 2026, down 1.3% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per gram |
|---|---|
| October 2026 | $26.62 |
| September 2026 | $26.62 |
| August 2026 | $26.62 |
| July 2026 | $26.62 |
| June 2026 | $26.63 |
| May 2026 | $26.70 |
| April 2026 | $26.72 |
| March 2026 | $26.71 |
| February 2026 | $26.70 |
| January 2026 | $26.72 |
| February 2024 | $26.96 |
| January 2024 | $26.96 |
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 Clindesse today: $26.62 per gram for Clindesse 2% vaginal cream 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). Clindesse has 22 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $26.62 pharmacies pay per gram 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 Clindesse
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 Clindesse, before manufacturer rebates.
- $7,295
- January to March 2026, the latest CMS has posted
For 37 people, about $178 per prescription fill - $37.8K
- 2025, the whole year
For 132 people, about $194 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $7,295 | 37 | $177.92 |
| 2025 | $37,791 | 132 | $193.80 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Clindesse only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. Clindamycin is an antibiotic that works by stopping the growth of bacteria.
Medicaid Prescriptions by Quarter
1,626 prescriptions in the four quarters to Q1 2026, $344.6K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 314 | $63,688 |
| Q4 2025 | 418 | $94,097 |
| Q3 2025 | 442 | $93,882 |
| Q2 2025 | 452 | $92,956 |
| Q1 2025 | 547 | $99,119 |
Source: CMS Medicaid State Drug Utilization Data, over Clindesse’s own package codes.
Clindesse Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 2% BASE | Cream | Vaginal | November 2004 | Prescription reference product |
Source: FDA Orange Book, Padagis US LLC. Listed for sale today by Padagis Israel Pharmaceuticals Ltd (FDA NDC Directory).
Clindesse NDC Codes and Packages
Each Clindesse 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 |
|---|---|---|---|
| 45802-0042-01 | CLINDAMYCIN PHOSPHATE 100 mg/5g cream | applicator of 5 g | Padagis Israel Pharmaceuticals Ltd |
| 45802-0042-01 | CLINDAMYCIN PHOSPHATE 100 mg/5g cream | applicator of 5 g | Padagis Israel Pharmaceuticals Ltd |
| 45802-0042-02 | CLINDAMYCIN PHOSPHATE 100 mg/5g cream | applicator of 5 g | Padagis Israel Pharmaceuticals Ltd |
| 45802-0042-02 | CLINDAMYCIN PHOSPHATE 100 mg/5g cream | applicator of 5 g | Padagis Israel Pharmaceuticals Ltd |
Source: the FDA NDC Directory, current listings only. Only packages sold under Clindesse’s own FDA approval (NDA 50793) are listed, never a generic. Some codes belong to companies that repackage Clindesse: it is the same medicine in a different package.
What a Generic Clindesse 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 Clindesse
Is there a generic for Clindesse right now?
Yes. The FDA NDC Directory lists a generic clindamycin phosphate in some form from 40 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Clindesse go generic?
There is no expected month yet. The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
Will generic clindamycin phosphate be the same as Clindesse?
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. At least 22 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $26.62 pharmacies pay per gram for Clindesse today to under $1.33. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Clindesse?
Yes. The FDA Orange Book lists approved generic versions from 22 companies, the first approved in February 1982: Hikma Pharmaceuticals USA Inc, Pfizer Inc, Padagis US LLC, Fougera Pharmaceuticals Inc and 18 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 Clindesse patent expire?
One patent is listed for Clindesse in the FDA Orange Book; it runs to December 2026. 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.
Has anyone challenged the Clindesse patents?
Yes. The first patent challenge to Clindesse reached the FDA in February 2015, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Clindesse cost now?
Pharmacies paid about $26.62 per gram for Clindesse 2% vaginal cream 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
- KalydecoIvacaftorJanuary to June 2028
- StribildCobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate2029 to 2030
- OrfadinNitisinoneFebruary 2033
- EnsacoveEnsartinib HydrochlorideNovember 2036
- AugtyroRepotrectinibNovember 2037
- WayrilzRilzabrutinibOctober 2040
About Clindesse
- Generic name clindamycin phosphate
- Company Padagis US LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since February 2015 (FDA)
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Clindesse
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, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.