CALDOLOR Drug Patent Profile

Which patents cover Caldolor, and what generic alternatives are available?

Caldolor is a drug marketed by Cumberland Pharms and is included in one NDA. There are ten patents protecting this drug.

This drug has fifty-six patent family members in fifteen countries.

The generic ingredient in CALDOLOR is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and fifty suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Caldolor

A generic version of CALDOLOR was approved as ibuprofen by CONTRACT PHARMACAL on October 15^th, 1986.

Summary for CALDOLOR

International Patents:	56
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	23
Patent Applications:	4,539
Drug Prices:	Drug price information for CALDOLOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALDOLOR
What excipients (inactive ingredients) are in CALDOLOR?	CALDOLOR excipients list
DailyMed Link:	CALDOLOR at DailyMed

See drug prices for CALDOLOR

Recent Clinical Trials for CALDOLOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yonsei University	N/A
St. Joseph's Hospital and Medical Center, Phoenix	Phase 2
St. Joseph's Hospital and Medical Center, Phoenix	Phase 4

See all CALDOLOR clinical trials

Pharmacology for CALDOLOR

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for CALDOLOR

CALDOLOR is protected by ten US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009		DISCN	No	No
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes

Expired US Patents for CALDOLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009

EU/EMA Drug Approvals for CALDOLOR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Rare Diseases	Pedea	ibuprofen	EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.	Authorised	no	no	no	2004-07-28

International Patents for CALDOLOR

See the table below for patents covering CALDOLOR around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005065674
Australia	2009350474	Treating critically ill patients with intravenous ibuprofen
Australia	2010274030	Treating patients with intravenous ibuprofen
Brazil	112012000773	MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES HUMANOS, MÉTODO PARA O TRATAMENTO DE PACIENTES HUMANOS, MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES CRITICAMENTE DOENTES, E MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES CRITICAMENTE DOENTES COM RISCO AUMENTADO DE EVENTOS CARDIOVASCULARES

Supplementary Protection Certificates for CALDOLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

CALDOLOR (ibuprofen) market dynamics and financial trajectory

CALDOLOR (ibuprofen; NDA 020915) is an FDA-approved branded NSAID that has followed a steady “low-to-mid single digit to low double digit” revenue pattern typical of mature, largely generic-equivalent oral NSAIDs. The business trajectory has been dominated by (1) persistent generic erosion of branded ibuprofen across OTC and Rx channels, (2) price pressure tied to substitution and formularies, and (3) distributor and channel mix effects rather than new clinical entrants. Financial performance has trended toward plateauing and gradual decline after the initial branded period, with incremental revenue coming from pediatric positioning, pull-through via institutional accounts, and renewals of formulary access where exclusive positioning is supported by package and contracting rather than clinical differentiation.

Key facts used for market modeling

• Product identity: CALDOLOR is ibuprofen for injection (parenteral NSAID), approved for short-term management of pain and fever in pediatric patients (labeling details vary by population and indication).
• Competitive set: generic ibuprofen (oral), other parenteral NSAIDs where available, and analgesic/antipyretic substitution in hospitals and urgent care settings.
• Primary commercial risk drivers:
  • High cross-substitutability of ibuprofen products within NSAID class.
  • Broad availability of low-cost generic ibuprofen.
  • Hospital procurement dynamics and group purchasing organization contracting.

---

What is the CALDOLOR market size and revenue trend by channel (hospital vs retail)?

Answer: Revenue is concentrated in acute-care and institutional purchasing, with retail presence limited by the product’s injectability and the strength of oral generic ibuprofen and OTC antipyretics. Over time, CALDOLOR has experienced channel-led deceleration as formularies and purchasing committees favor lower unit cost options unless specific pediatric/parenteral criteria drive utilization.

Channel mix dynamics

Hospital/institutional

Last updated: July 22, 2026

• Drivers: pediatric pain/fever protocols, perioperative pathways where IV analgesia is preferred, emergency department throughput, and standing order sets.
• Constraints: purchasing committees weigh total cost of care, inventory complexity, and bundled analgesia pathways.
• Commercial effect: even when CALDOLOR retains formulary access, usage volumes trend with procedure volumes and seasonal febrile illness cycles, not with brand expansion.

Retail/pharmacy

• Lower fit: CALDOLOR is not a like-for-like substitute for OTC oral ibuprofen for routine fever management.
• Impact: retail channel contributes to limited brand awareness but does not sustain large revenue growth because oral ibuprofen generics and OTC products dominate.

---

How does CALDOLOR face generic and therapeutic substitution pressure?

Answer: CALDOLOR’s economics are exposed to class substitution because ibuprofen is widely available as low-cost generics in oral dosage forms, while alternative parenteral NSAID strategies and non-NSAID analgesics compete in the same treatment window.

Substitution vectors that compress pricing

• Oral switch in step-down care: hospitals often start parenteral therapy then switch to oral ibuprofen or acetaminophen once able to take oral meds.
• Payer and formulary substitution: NSAID-to-NSAID substitution and acetaminophen-first pathways reduce the addressable market for parenteral ibuprofen.
• Procurement cost controls: group purchasing organizations pressure net price through tendering and preferred agent lists.

Margin implications

• Net price declines are usually more durable than gross margin gains because branded injectables face higher competitive frequency in contracting cycles.
• Any revenue uplift from pediatric protocol adoption is typically offset by stronger pricing terms in successive bids.

---

Which products compete with CALDOLOR and how do they affect market share?

Answer: CALDOLOR competes primarily against (1) parenteral analgesics and antipyretics used in inpatient and ED pediatric care and (2) alternative NSAID strategies, plus the downstream oral ibuprofen market that competes for continuation therapy.

Competitive framework

• Parenteral analgesic/antipyretic alternatives: acetaminophen formulations, opioid-sparing regimens, and other IV NSAID options where used.
• Class competition: hospitals decide among NSAIDs and non-NSAIDs based on contraindications, renal risk, and bleeding risk profiles.
• Unit economics: IV dosing cost, wastage, and administration workflow often determine selection more than clinical trial novelty.

Practical impact on commercial trajectory

• Brand market share tends to be stable only where clinical pathways specifically call for parenteral ibuprofen.
• When pathways allow substitutions, CALDOLOR loses elasticity and tracks procedure and seasonality rather than brand-driven volume.

---

When does CALDOLOR lose exclusivity, and what does that mean for revenue erosion?

Answer: The revenue erosion risk is already realized to the extent applicable if branded exclusivity has expired and generics or authorized competitors entered the parenteral ibuprofen landscape or parallel indications. Post-exclusivity, CALDOLOR’s trajectory typically becomes a function of remaining formulary access and any ongoing exclusivity tied to specific formulation, method, or labeling.

Exclusivity and expiration mechanics to monitor

• Patent estate expiry: both composition and use claims affect whether FDA approval for generics can occur.
• Orange Book-listed protections: formulations and method-of-use claims can extend practical entry timelines through patent litigation or design-around barriers.
• Market effect: once entry is permitted, branded injectables often face rapid net price compression and volume substitution.

What to model for financial planning

• Gross-to-net decline over successive contracting cycles.
• Volume normalization to pre-entry baseline and incremental share retention tied to pediatric-specific dosing protocols.

---

What patents protect CALDOLOR and how strong is the patent estate?

Answer: CALDOLOR’s patent strength depends on the existence and enforceability of Orange Book-listed patents covering the ibuprofen injection product, including formulation and use claims. The commercial leverage typically tracks whether key claims remain unchallenged or were successfully defended in litigation.

Patent estate topics that affect commercial life

• Composition/formulation patents: can block generic parenteral product approval if claim scope is not easily designed around.
• Method-of-use patents: can restrict entry tied to dosing regimens, pediatric indications, or specific clinical parameters.
• Manufacturing method patents: may raise barriers for process replication and improve settlement leverage.

Litigation risk channel

• Patent challenges (including Paragraph IV-type challenges in an Orange Book context) often produce:
  • early entry risk windows,
  • settlement-triggered launch delays,
  • or enforced stop-stay periods tied to litigation schedules.

---

What is the Orange Book status of CALDOLOR and are there generic or AB-rated alternatives?

Answer: CALDOLOR’s Orange Book status determines whether generic or “AB-rated” products are available for substitution. For branded injectables, Orange Book-listed patents usually define the practical entry window and influence settlement and launch calendars.

How Orange Book status maps to financial trajectory

• No challenged patents / clean landscape: continued brand share retention with slower revenue erosion.
• Multiple challenged patents: higher risk of rapid price compression after entry approval or litigation resolution.
• Fewer listed patents with early expiry: faster commoditization and lower net price.

---

Have there been CALDOLOR Paragraph IV challenges, litigation, or settlements?

Answer: Paragraph IV-type challenges and associated litigation timing generally govern branded injection erosion. If CALDOLOR has faced patent challenges, the financial pattern typically shows:

• pre-litigation stability,
• step-change decline around final court rulings, settlement start dates, or launch permissions,
• ongoing net price decreases due to competitive entry and contracting renegotiations.

Litigation-driven revenue mechanics

• Brand revenue declines can occur before launch if hospital purchasing shifts in anticipation of cheaper alternatives.
• Settlement structures can produce temporary revenue stabilization if generic entry is delayed.

---

What is CALDOLOR FDA regulatory status and how does it impact competitive entry?

Answer: CALDOLOR is an FDA-approved branded product under NDA authority; its regulatory status, labeling, and associated patent listings determine the feasibility and timing of generic substitution. Regulatory pathway constraints influence launch readiness and can slow erosion even when market competition exists.

Regulatory vectors affecting market dynamics

• Labeling scope (pediatric-only vs broader populations).
• Dosing regimen specifics (weight-based pediatric dosing can be harder to match if patents cover particular regimens).
• Manufacturing controls for injectable NSAIDs.

---

How does CALDOLOR pricing and net revenue typically evolve after contracting cycles?

Answer: CALDOLOR net revenues generally track a “down and flatten” pattern: initial high gross margin pricing followed by stepwise net price reductions driven by wholesaler discounts, GPO tender terms, and payer contracting. The decline rate depends on whether alternative agents win preferred contracting status.

Factors that shift the price curve

• Competitive launches or authorized equivalents.
• Increased hospital preference for lower-cost parenteral or oral therapies.
• Seasonality in pediatric fever incidence affecting demand and negotiating leverage.

---

What commercial milestones matter most for CALDOLOR’s financial trajectory?

Answer: The most influential milestones are not incremental clinical results but business events that move purchasing behavior:

1. formulary inclusion changes (preferential vs non-preferential),
2. tender outcomes with GPOs,
3. patent litigation outcomes linked to generic entry,
4. label expansion or restriction tied to pediatric usage protocols.

---

How does CALDOLOR compare with other NSAIDs (financial exposure and market durability)?

Answer: Compared with oral NSAIDs, CALDOLOR has a narrower eligible population and a more constrained usage scenario due to injection administration requirements. That narrows upside but can also reduce direct cannibalization from oral OTC substitutes. Net durability, however, is still limited by broad NSAID interchangeability in hospitals and EDs.

Comparison grid (business impact, not clinical outcomes)

Attribute	CALDOLOR (ibuprofen injection)	Oral generic ibuprofen/OTC	Parenteral alternatives
Substitution frequency	High within acute-care pathways	Very high	High within ED/inpatient analgesia
Net price pressure	Moderate-to-high	High	Moderate
Demand driver	Pediatric pain/fever protocols, step-down transitions	Everyday fever/pain	ED/inpatient pathways
Revenue scalability	Lower	Higher	Medium

---

Key Takeaways

• CALDOLOR’s revenue trajectory is primarily driven by institutional contracting, pediatric pathway utilization, and competitive substitution, not by brand-driven category creation.
• The injection format narrows the market but does not immunize CALDOLOR from net price compression because hospitals can substitute within analgesic/antipyretic strategies.
• Financial planning should treat CALDOLOR as a mature, contract-sensitive branded injectable with exposure to Orange Book patent status and litigation outcomes that can accelerate entry-driven erosion.
• Market durability depends on maintaining preferred status in pediatric pain/fever protocols and limiting cannibalization via step-down and therapeutic switching.

---

FAQs

1. How does CALDOLOR utilization change between the ED and inpatient pediatric wards?
2. What contracting levers (GPO vs payer formulary vs hospital committee) most affect CALDOLOR net pricing?
3. How do settlement terms tied to CALDOLOR patent disputes typically influence timing of generic launches?
4. What risk does step-down therapy switching (IV to oral) pose to CALDOLOR volume?
5. What indicators in FDA and Orange Book records best predict imminent market erosion for CALDOLOR?

---

References

1. U.S. Food and Drug Administration. “Drugs@FDA: CALDOLOR (ibuprofen).” FDA.
2. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for CALDOLOR.” FDA.