DIPHENHYDRAMINE CITRATE; IBUPROFEN - Generic Drug Details

What are the generic sources for diphenhydramine citrate; ibuprofen and what is the scope of patent protection?

Diphenhydramine citrate; ibuprofen is the generic ingredient in two branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, Dr Reddys Labs Ltd, Perrigo R And D, and Pld Acquisitions Llc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-four suppliers are listed for this compound.

Summary for DIPHENHYDRAMINE CITRATE; IBUPROFEN

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	34
Clinical Trials:	2
DailyMed Link:	DIPHENHYDRAMINE CITRATE; IBUPROFEN at DailyMed

Recent Clinical Trials for DIPHENHYDRAMINE CITRATE; IBUPROFEN

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1

See all DIPHENHYDRAMINE CITRATE; IBUPROFEN clinical trials

Pharmacology for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DIPHENHYDRAMINE CITRATE; IBUPROFEN

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL PM	Tablets	diphenhydramine citrate; ibuprofen	200 mg/38 mg	021394	1	2017-12-28

US Patents and Regulatory Information for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pld Acquisitions Llc	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	211404-001	Apr 11, 2024		OTC	No	No
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005		OTC	Yes	Yes
Dr Reddys Labs Ltd	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	090619-001	Jul 8, 2009		OTC	No	No
Perrigo R And D	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	079113-001	Dec 22, 2008		OTC	No	No
Aurobindo Pharma	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	216204-001	May 31, 2022		OTC	No	No

Expired US Patents for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005	8,263,647

Diphenhydramine Citrate and Ibuprofen: Market Dynamics and Financial Trajectory

Last updated: May 7, 2026

What is the market structure for diphenhydramine citrate?

Diphenhydramine citrate is a first-generation antihistamine marketed across multiple OTC and branded product formats (e.g., allergy symptom relief, motion sickness indications, sleep aids where permitted). In the US, the active ingredient is off-patent, so the market is structurally driven by:

• OTC commoditization: low price elasticity for consumers seeking immediate symptom relief, but frequent switching among equivalent generics
• Multi-claim product breadth: the same molecule supports combination products (with decongestants, analgesics, antitussives) and different dosing presentations
• Distribution scale and pack architecture: national wholesalers, club channels, and pharmacy chains price-match; unit volume depends on pack size and promotions
• Regulatory and label constraints: safety messaging and age/dosing limits shape substitution and reduce expansion in pediatric segments

Financial trajectory in this structure is typically characterized by volume stability with margin compression post generic normalization, followed by periodic margin relief when manufacturers cycle through promotions, retail network exclusivity on specific NDCs, or brand refresh in certain segments.

What is the market structure for ibuprofen?

Ibuprofen has a similar off-patent profile in the US and most major markets. It is a mature NSAID active with extensive generic penetration. Market dynamics are shaped by:

• High substitution: equivalent-dose generics compete aggressively on price
• OTC shelf competition: store brands and large-brand generics dominate share
• Formulation and delivery differentiation: tablets, liquids, suspensions, pediatric dosing formats, and targeted relaunches of faster-acting and concentrated variants
• Implied demand by indication: fever, pain, dysmenorrhea, and broader self-medication cohorts

Financial trajectory for ibuprofen usually follows a pattern of robust category volume with structural price pressure, offset by mix shifts toward higher-velocity SKUs, larger market participation by pharmacy store brands, and periodic premiumization around specific pediatric formats or targeted symptom claims.

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How do supply and pricing dynamics affect diphenhydramine citrate’s economics?

In OTC antihistamine markets, manufacturer economics hinge on:

• Generic capacity and procurement: active pharmaceutical ingredient sourcing and contract manufacturing drive unit cost discipline
• Retail promotion cycles: margins compress during heavy promotional windows; stable baseline margins depend on NDC-level channel pricing
• Pack-size strategy: larger counts and value packs raise revenue per customer and reduce per-tablet distribution friction

For diphenhydramine citrate specifically, the molecule’s core demand drivers are allergic rhinitis and urticaria relief, with secondary usage for sedation or sleep (where label/regulatory posture allows in the jurisdiction). That demand base is recurrent but competes on price due to generic equivalents.

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How do supply and pricing dynamics affect ibuprofen’s economics?

Ibuprofen faces intense competitive pressure because:

• it is widely available in multiple retail tiers (independent pharmacy, chain pharmacy, mass, club)
• manufacturers can adjust mix through form factor and pack size
• OTC switching is easy for consumers because efficacy is perceived as dose-aligned and brand-agnostic

Economics stabilize when manufacturers succeed in:

• securing pharmacy and club planograms for specific SKUs and pack sizes
• maintaining supply continuity to avoid stockouts that drive lost volume
• using formulation-level differentiation for pediatric and convenience formats (liquids/suspensions, chewables, concentrated dosing where permitted)

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What do reimbursement and regulatory trends imply for both markets?

Both molecules are primarily consumer self-pay OTC products in many markets, which makes reimbursement policy less central than:

• labeling and safety warnings
• age restrictions
• pharmacovigilance-driven product management

Regulatory attention is relevant for OTC NSAIDs due to gastrointestinal and cardiovascular risk messaging, and for first-generation antihistamines due to sedation and anticholinergic adverse effects. These forces do not typically remove OTC supply, but they can slow expansion into lower-usage demographics and can constrain certain combination products.

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What is the financial trajectory implied by the patent and regulatory status?

Both diphenhydramine citrate and ibuprofen are mature actives with extensive generic availability. That status implies a financial trajectory dominated by:

• declining or capped manufacturer ASP (average selling price)
• fixed-cost leverage via scale manufacturing
• margin management through channel mix and SKU engineering
• marketing intensity focused on shelf visibility and pack economics rather than innovation-driven differentiation

In practice, the category’s financial outcomes are less about incremental IP and more about operational execution: procurement cost, manufacturing yield, logistics, and retailer program participation.

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How do channel dynamics shape revenue growth versus profitability?

OTC pharmaceuticals usually show:

• revenue growth through unit volume and pack-price architecture
• profit volatility tied to promo intensity, trading terms, and slotting arrangements

For diphenhydramine citrate, channel growth is constrained by competition within the antihistamine class and the consumer tendency to switch within OTC allergy categories. For ibuprofen, channel growth can be steadier because pain and fever are broad use cases, but pricing compression is persistent.

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How does combination-product strategy alter outcomes for diphenhydramine citrate and ibuprofen?

Combination products can improve manufacturer economics by:

• expanding addressable symptom profiles (e.g., “cold and allergy” formats for antihistamines)
• capturing consumers who would otherwise buy multiple items
• shifting mix toward higher-value SKUs

However, combination strategy increases complexity in regulatory compliance, stability testing, and formulation cost. It also amplifies promotional cadence and channel demand variability.

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What does the outlook look like for the next market cycle?

Near-to-mid-term market outlook for both actives depends on:

• continued generic penetration and retail store brand expansion
• consumer preference shifts toward targeted formulations (pediatric dosing convenience, faster onset formats)
• category-level demand stability for pain and allergy seasons

Financially, the likely trajectory is stable volume with continued pricing pressure, leading to modest top-line growth and selective margin upside only when mix improves (pack size, format, combination portfolios) or when input costs fall.

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Comparative market dynamics: diphenhydramine citrate vs ibuprofen

Dimension	Diphenhydramine citrate	Ibuprofen
Core demand	Allergy symptoms, sleep/sedation where permitted	Pain and fever; broad OTC use
Competitive intensity	High within antihistamines; generics dominate	Very high across NSAID pain relievers; generics dominate
Key mix levers	Combination cold/allergy products, pack sizes	Pediatric formats, concentrated dosing, faster-acting variants
Margin driver	Promo control, channel pricing discipline	Procurement cost, format differentiation, retailer program retention
Likely financial profile	Volume steadiness with recurring margin pressure	Category volume stability with persistent price competition

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Key takeaways

1. Both diphenhydramine citrate and ibuprofen are mature OTC actives with generic-dominated pricing, which drives a financial trajectory built on volume and mix rather than IP renewal.
2. Revenue growth is channel- and pack-driven while profitability is promo- and input-cost driven.
3. Combination products and formulation differentiation are the primary levers to improve economics without relying on new patents.

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FAQs

1) Is diphenhydramine citrate or ibuprofen protected by meaningful ongoing patent exclusivity in major markets?

No. Both actives are broadly available as generics and OTC equivalents, so the commercial landscape is dominated by non-exclusivity economics.

2) What most influences quarterly profitability for these OTC categories?

Retail promotion intensity, channel mix (store brand vs branded generic), and manufacturing procurement cost are the dominant drivers.

3) Which active has more stable recurring demand?

Ibuprofen typically has broader “pain and fever” use cases; diphenhydramine citrate is more seasonally and indication-constrained around allergy demand.

4) Do formulation changes matter financially?

Yes. Pediatric formats, liquids/suspensions, and targeted convenience packs can shift mix and improve net pricing relative to pure tablet equivalence.

5) What is the biggest risk to the financial trajectory?

Price undercutting in generic-heavy channels and margin erosion during heavy promotions are the most consistent threats to profitability.

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References

[1] FDA. OTC drug monograph and labeling information for antihistamines and NSAIDs (public resources). U.S. Food and Drug Administration website. https://www.fda.gov/drugs (accessed 2026-05-07).
[2] DailyMed. Drug labeling for diphenhydramine citrate products and ibuprofen products (package insert details and indications). National Library of Medicine. https://dailymed.nlm.nih.gov/ (accessed 2026-05-07).
[3] IMS Institute for Healthcare Informatics. Global and US OTC market structure reports (public summaries on OTC competition and channel dynamics). IQVIA Institute. https://www.iqvia.com/insights/the-iqvia-institute (accessed 2026-05-07).