CALDOLOR® (IBUPROFEN) INJECTION CMS ISSUED J-CODE NOW ASSOCIATED WITH REIMBURSEMENT PRICE SUPPORTING NON-OPIOID PAIN MANAGEMENT

Rhea-AI Summary

Cumberland Pharmaceuticals (Nasdaq: CPIX) announced on Dec 8, 2025 that Caldolor® (ibuprofen) Injection's permanent J-code J1741 is now officially associated with a reimbursement price, creating a CMS-covered, non-opioid option for pain and fever management.

The update links an established reimbursement price to J1741, which the company says supports opioid-sparing strategies, encourages providers to update billing systems, and may improve access to Caldolor for adult and pediatric patients where ibuprofen is indicated.

Positive

• J-code J1741 now associated with reimbursement price (Dec 8, 2025)
• CMS-covered non-opioid option for pain and fever management
• Encourages provider reimbursement and billing updates to improve access

Negative

• Reimbursement price amount not disclosed in the announcement
• Caldolor contains contraindications (NSAID hypersensitivity, CABG restriction)

News Market Reaction

-9.21% 2.4x vol

7 alerts

-9.21% News Effect

+8.0% Peak in 23 hr 55 min

-$4M Valuation Impact

$36M Market Cap

2.4x Rel. Volume

On the day this news was published, CPIX declined 9.21%, reflecting a notable negative market reaction. Argus tracked a peak move of +8.0% during that session. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $4M from the company's valuation, bringing the market cap to $36M at that time. Trading volume was elevated at 2.4x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Caldolor J-code dose: 100 mg

1 metrics

Caldolor J-code dose 100 mg J1741 – Injection, ibuprofen, 100 mg

Market Reality Check

Price: $3.93 Vol: Volume 41,662 is below 20...

low vol

$3.93 Last Close

Volume Volume 41,662 is below 20-day average of 71,283 (relative volume 0.58x) low

Technical Price at $2.39 is trading below the 200-day MA of $3.87, well off the $7.25 52-week high

Peers on Argus

CPIX up 3.91% while key peers are mixed: DRRX -1.04%, RMTI -1.31%, ASRT -0.58% v...

CPIX up 3.91% while key peers are mixed: DRRX -1.04%, RMTI -1.31%, ASRT -0.58% versus CRDL +10.53% and INCR +2.40%, indicating a stock-specific reaction to the Caldolor reimbursement update rather than a broad sector move.

Historical Context

5 past events · Latest: Nov 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 04	Earnings update	Positive	-3.6%	Reported Q3 and year‑to‑date revenue growth with solid balance sheet metrics.
Oct 28	Earnings pre-announcement	Neutral	-1.5%	Scheduled Q3 2025 results release and outlined existing product portfolio and trials.
Oct 20	Product acquisition	Positive	+3.5%	Announced Talicia co‑commercialization deal and <b>$4.0M</b> investment with revenue share.
Oct 20	Partnership terms	Positive	+3.5%	Detailed Talicia partnership economics, including <b>30%</b> stake and revenue split.
Oct 13	Market access deal	Positive	-2.6%	Vibativ added to Premier group purchasing contract covering thousands of hospitals.

Pattern Detected

Across the last five news events, CPIX saw negative 24h reactions after three seemingly positive updates, suggesting a tendency toward selling into good news.

Recent Company History

Over recent months, Cumberland reported Q3 2025 net revenues of $8.3M and year‑to‑date revenues of $30.8M, alongside assets of $66M and cash of $15M. Strategically, it added FDA‑approved Talicia via a co‑commercialization deal, invested $4.0M for a 30% stake, and expanded Vibativ access through a Premier group purchasing agreement. Despite these positive steps, three of the last five news items were followed by negative price reactions, making today’s favorable reimbursement news for Caldolor notable against a mixed trading history.

Market Pulse Summary

The stock moved -9.2% in the session following this news. A negative reaction despite positive reimb...

Analysis

The stock moved -9.2% in the session following this news. A negative reaction despite positive reimbursement news would fit a recent pattern where three of the last five constructive announcements were followed by 24‑hour declines. The update formally links Caldolor’s J-code to a CMS reimbursement price, enhancing access to a non-opioid IV ibuprofen option. A selloff in that context could reflect profit‑taking or broader risk sentiment rather than the substance of the news, underscoring that strong fundamentals do not always translate into immediate share support.

Key Terms

j-code, cms, intravenous, contraindicated, +2 more

6 terms

j-code regulatory

"The product's permanent J-code, J1741, is now officially associated"

A J-code is a standardized billing code used by U.S. healthcare payers to identify specific injectable or infused drugs and biologic therapies given in clinics or hospitals. For investors, J-codes matter because they determine how treatments are billed and reimbursed by insurers and government programs; having a clear code can make it easier for a medicine to be paid for and for a company to forecast sales, much like a product SKU that allows a store to track and sell an item.

cms regulatory

"providing healthcare providers with a CMS-covered, non-opioid option"

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that sets rules, payment rates and coverage decisions for major public health insurance programs; think of it as both a giant insurer and the rulebook maker for how many healthcare providers and drug makers get paid by government programs. Its policy changes and reimbursement decisions can materially affect revenue, profit forecasts and valuations for hospitals, insurers, device makers and drug companies, so investors watch CMS announcements closely.

intravenous medical

"It was the first FDA-approved intravenous therapy for fever."

Intravenous means delivering a drug, fluid or substance directly into a vein so it goes straight into the bloodstream. For investors, that matters because intravenous products often act faster, require different manufacturing, regulatory steps and healthcare settings (like hospitals or clinics), and can affect pricing, adoption and revenue profiles in ways that differ from pills or topical treatments — like turning a slow-release delivery into a direct tap to the system.

contraindicated medical

"Caldolor is contraindicated in patients with known hypersensitivity"

An instruction that a drug, treatment, device, or procedure should not be used in a particular situation because it could harm the patient or make the therapy ineffective. For investors, contraindications matter because they narrow who can safely use a product, affect labeling and regulatory approval, limit market size, and raise potential liability — like a clear “do not use” warning that reduces the pool of customers and revenue potential.

nsaids medical

"hypersensitivity to ibuprofen or other NSAIDs, patients with a history"

Nonsteroidal anti-inflammatory drugs are a class of medicines used to reduce pain, fever, and inflammation; common examples include ibuprofen and naproxen. They matter to investors because they drive large, predictable sales across over‑the‑counter and prescription markets but are closely watched for safety issues, regulatory decisions, and generic competition—like widely used household tools whose recalls or lost exclusivity can quickly change a company’s revenue outlook.

coronary artery bypass graft (cabg) medical

"during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery."

A coronary artery bypass graft (CABG) is a surgical procedure that restores blood flow to the heart by using a blood vessel taken from elsewhere in the body to create a new route around blocked coronary arteries — like rerouting traffic around a closed road. Investors care because CABG volumes, outcomes and costs influence hospital revenue, medical device and drug demand, insurance payouts, and regulatory or reimbursement decisions in the cardiovascular sector.

AI-generated analysis. Not financial advice.

NASHVILLE, Tenn., Dec. 8, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), today announced an important update regarding its Caldolor^® (ibuprofen) Injection. The product's permanent J-code, J1741, is now officially associated with a reimbursement price, providing healthcare providers with a CMS-covered, non-opioid option for managing pain and fever.

As the nation continues to face an opioid crisis, non-opioid alternatives, like Caldolor, play a critical role in reducing reliance on opioid medications, supporting safer pain management strategies for patients. With the reimbursement price now linked to J1741, providers can access a CMS-covered, non-opioid pain management option and align treatment strategies with opioid-sparing initiatives.

Caldolor J-Code Details:

• Product: Caldolor^® (ibuprofen) Injection
• J-Code: J1741 – Injection, ibuprofen, 100 mg
• Status: Now associated with reimbursement price

"With Caldolor now linked to an established reimbursement price, healthcare providers have a reimbursable non-opioid alternative to help address pain management," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "This update supports providers in making clinically appropriate decisions while contributing to efforts to reduce opioid exposure and reinforces our commitment to improving access to Caldolor and ensuring patients receive the pain management they need."

Providers are encouraged to update their internal systems, billing teams, and reimbursement processes to reflect this change. For additional support with coding, coverage, or payment questions, please contact your Cumberland Pharmaceuticals representative or email caldolor@cumberlandpharma.com.

About Caldolor^® (ibuprofen) Injection

Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes:

• Acetadote^® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
• Caldolor^® (ibuprofen) injection, for the treatment of pain and fever;
• Kristalose^® (lactulose) oral, a prescription laxative, for the treatment of constipation;
• Sancuso^® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
• Vaprisol^® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
• Vibativ^® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections, and
• Talicia^®(omeprazole magnesium, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection.

The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.

For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website www.cumberlandpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

View original content:https://www.prnewswire.com/news-releases/caldolor-ibuprofen-injection-cms-issued-j-code-now-associated-with-reimbursement-price-supporting-non-opioid-pain-management-302634989.html

SOURCE Cumberland Pharmaceuticals Inc.

FAQ

What did Cumberland Pharmaceuticals announce about Caldolor J1741 on Dec 8, 2025?

The company said Caldolor's permanent J-code J1741 is now associated with a reimbursement price and is CMS-covered.

How does the J1741 reimbursement change affect CPIX shareholders?

The announcement links a reimbursement price to J1741, which may improve Caldolor access and billing for providers; no revenue figures were disclosed.

What is J1741 for Caldolor and who is it indicated for?

J1741 is the code for ibuprofen 100 mg injection, indicated for adults and pediatric patients for pain and fever per prescribing information.

Do providers need to take action after the J1741 reimbursement update?

Yes; providers are encouraged to update internal systems, billing teams, and reimbursement processes to reflect the change.

Does the announcement specify the CMS reimbursement amount for J1741?

No; the company announced an association with a reimbursement price but did not disclose the specific amount.

Will the J1741 update support opioid-sparing strategies for hospitals using Caldolor?

The company states the reimbursement link provides a CMS-covered non-opioid option that supports opioid-sparing initiatives.