ADVIL PM Drug Patent Profile

Which patents cover Advil Pm, and when can generic versions of Advil Pm launch?

Advil Pm is a drug marketed by Haleon Us Holdings and is included in two NDAs.

The generic ingredient in ADVIL PM is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for ADVIL PM

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADVIL PM
What excipients (inactive ingredients) are in ADVIL PM?	ADVIL PM excipients list
DailyMed Link:	ADVIL PM at DailyMed

Pharmacology for ADVIL PM

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

Paragraph IV (Patent) Challenges for ADVIL PM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL PM	Tablets	diphenhydramine citrate; ibuprofen	200 mg/38 mg	021394	1	2017-12-28
ADVIL PM	Capsules	diphenhydramine hydrochloride; ibuprofen	200 mg/25 mg	021393		2016-02-16

US Patents and Regulatory Information for ADVIL PM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005		OTC	Yes	Yes
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005		OTC	Yes	Yes

Expired US Patents for ADVIL PM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	8,883,849
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005	8,263,647
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	9,155,718

International Patents for ADVIL PM

See the table below for patents covering ADVIL PM around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA03006364	TRATAMIENTO DE PERTURBACIONES DEL SUEnO. (TREATMENT OF SLEEP DISTURBANCES.)
Japan	4402882
Spain	2251584

ADVIL PM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Advil PM

Overview of Advil PM

Advil PM, a product of Pfizer's Consumer Healthcare division, combines the pain-relieving properties of ibuprofen with the sleep aid diphenhydramine citrate. This formulation is designed to provide relief from occasional sleeplessness associated with minor aches and pains[2][5].

Market Size and Growth

The market for Advil PM is closely tied to the broader over-the-counter (OTC) pain reliever market. Here are some key metrics:

• Advil Market Size: The Advil market, which includes various formulations like Advil PM, was valued at $21.01 billion in 2023 and is projected to reach $31.03 billion by 2031, growing at a CAGR of 5.1% during the forecast period of 2024-2031[1].

• Global Ibuprofen Market: The global ibuprofen market, which is a key component of Advil PM, was valued at $1.43 billion in 2023 and is expected to reach $1.76 billion by 2032, growing at a CAGR of 2.44% during the forecast period of 2024-2032[3].

Drivers of Market Growth

Several factors are driving the growth of the Advil PM market:

Raising Awareness of Pain Management

Public health campaigns, educational programs, and advice from medical professionals have increased consumer awareness of effective pain management techniques. This heightened awareness has led to a greater demand for trustworthy OTC pain relievers like Advil PM[1].

Increasing Chronic Illness Rates

The rise in chronic illnesses such as arthritis, headaches, and muscular soreness has increased the demand for pain relief medications. Advil PM, with its dual action of pain relief and sleep aid, is well-positioned to meet this demand[1].

Expanding Distribution Networks

The availability of Advil PM has been enhanced by its widespread stocking in pharmacies, supermarkets, and online platforms. The growth of e-commerce, particularly post-COVID-19, has made it easier for consumers to purchase products like Advil PM from the comfort of their homes[1].

Promotional and Marketing Techniques

Aggressive marketing and promotional strategies by pharmaceutical companies have significantly impacted the Advil PM market. Multi-channel marketing approaches, including influencer partnerships, social media, and television advertising, have helped in reaching a wide range of consumer segments and fostering consumer trust and loyalty[1].

Regional Market Dynamics

The market for Advil PM varies significantly across different regions:

Europe

Europe has a strong healthcare system and a large customer base aware of pain management options. Countries like Germany, France, and the UK have a high propensity for self-medication, making them key markets for Advil PM[1].

Asia-Pacific

The Asia-Pacific region is the largest shareholder in the global ibuprofen market and is expected to expand substantially during the forecast period. Factors such as cost-efficient manufacturing in countries like China and India, along with rising healthcare expenditures, are driving this growth[3].

Middle East and Africa

The market in the Middle East and Africa is growing due to increasing urbanization and changing consumer habits, despite challenges with healthcare infrastructure[1].

Latin America

Latin America is also experiencing growth driven by consumers' desire for reliable pain relief options and increasing disposable income and health consciousness[1].

Challenges and Constraints

Despite the positive growth trajectory, the Advil PM market faces several challenges:

Competition from Alternatives

The market is heavily competitive, with natural and herbal medicines, generics, and other branded medications offering similar effectiveness at lower costs. This competition can erode Advil PM's market share and brand loyalty[1].

Price Sensitivity

Consumers are increasingly price-sensitive, often opting for cheaper alternatives. This forces companies to innovate and reduce prices to remain competitive, which can impact profitability[1].

Supply Chain Disruptions

Global supply chain disruptions, such as those in the Red Sea and Gulf of Aden, have led to increased freight costs and delays, which can affect the pricing and availability of Advil PM[4].

Financial Trajectory

The financial performance of Advil PM is closely tied to the broader trends in the OTC pain reliever market:

• Revenue Growth: The projected growth of the Advil market to $31.03 billion by 2031 indicates a robust financial trajectory for Advil PM, driven by increasing demand and effective marketing strategies[1].

• Price Dynamics: The anticipated surge in ibuprofen prices due to strong demand, supply chain challenges, and global economic uncertainties may impact the pricing of Advil PM. However, strategic marketing and promotional efforts can help maintain demand despite price increases[4].

Key Takeaways

• Growing Demand: The market for Advil PM is driven by increasing consumer awareness of pain management and rising chronic illness rates.
• Expanding Distribution: Widespread availability through various distribution channels has boosted the market.
• Effective Marketing: Aggressive marketing strategies have enhanced consumer trust and loyalty.
• Regional Variations: Market dynamics vary significantly across Europe, Asia-Pacific, Middle East and Africa, and Latin America.
• Challenges: Competition from alternatives, price sensitivity, and supply chain disruptions pose significant challenges.
• Financial Outlook: The market is expected to grow significantly, but price dynamics and supply chain issues need careful management.

FAQs

1. What are the key ingredients in Advil PM? Advil PM contains ibuprofen and diphenhydramine citrate, combining pain relief with a sleep aid[2].

2. How is the global ibuprofen market expected to grow? The global ibuprofen market is expected to grow at a CAGR of 2.44% from 2024 to 2032, reaching $1.76 billion by 2032[3].

3. What are the main drivers of the Advil PM market? The main drivers include increasing consumer awareness of pain management, rising chronic illness rates, and expanding distribution networks[1].

4. How does regional market dynamics impact Advil PM sales? Regional dynamics, such as strong healthcare systems in Europe and cost-efficient manufacturing in Asia-Pacific, significantly influence sales and growth prospects[1][3].

5. What challenges does the Advil PM market face? The market faces challenges from competition, price sensitivity, and supply chain disruptions, which can impact sales and profitability[1][4].