ORACEA Drug Patent Profile

When do Oracea patents expire, and when can generic versions of Oracea launch?

Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eight countries.

The generic ingredient in ORACEA is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the doxycycline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oracea

A generic version of ORACEA was approved as doxycycline by SUN PHARM INDS LTD on November 22^nd, 2000.

Summary for ORACEA

International Patents:	18
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	13
Patent Applications:	3,109
Drug Prices:	Drug price information for ORACEA
Drug Sales Revenues:	Drug sales revenues for ORACEA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORACEA
What excipients (inactive ingredients) are in ORACEA?	ORACEA excipients list
DailyMed Link:	ORACEA at DailyMed

See drug prices for ORACEA

See drug sales revenues for ORACEA

Recent Clinical Trials for ORACEA

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

Sponsor	Phase
The Skin of Color Society	Phase 4
Wake Forest University Health Sciences	Phase 4
Derm Research, PLLC	Phase 4

See all ORACEA clinical trials

Pharmacology for ORACEA

Drug Class

Tetracycline-class Drug

Paragraph IV (Patent) Challenges for ORACEA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORACEA	Delayed-release Capsules	doxycycline	40 mg	050805	1	2008-12-12

US Patents and Regulatory Information for ORACEA

ORACEA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes			Y
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes			Y
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes			Y

Expired US Patents for ORACEA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006

EU/EMA Drug Approvals for ORACEA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Doxirobe	Doxycycline	EMEA/V/C/000044 Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy.	Withdrawn	no	no	no	1999-09-16

International Patents for ORACEA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20040007488
New Zealand	334512	Method of using tetracycline compounds for inhibition of nitric oxide production
Japan	4451930

ORACEA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ORACEA (Doxycycline Hydrochloride)

Introduction

ORACEA, a brand name for Doxycycline Hydrochloride capsules, is a tetracycline-class drug specifically indicated for the treatment of inflammatory lesions associated with rosacea in adult patients. Here, we delve into the market dynamics and financial trajectory of ORACEA, highlighting key factors influencing its demand, supply, and pricing.

Market Demand for ORACEA

The demand for ORACEA is robust and driven by several factors:

Prevalence of Rosacea

Rosacea is a common skin condition affecting millions of people worldwide. In the U.S., the rosacea treatment market is significant, with North America accounting for a substantial share of the global market. The U.S. rosacea treatment market alone generated approximately $897.7 million in revenue in 2023, with ORACEA being a key player in this segment[4].

Clinical Efficacy

ORACEA has demonstrated clinical efficacy in treating inflammatory lesions of rosacea. The drug's approval by the U.S. FDA and its inclusion in treatment guidelines further solidify its position in the market[5].

Generic Competition and New Entrants

Despite the entry of generic versions, such as Lupin Limited's generic iteration of ORACEA, the brand remains a preferred choice due to its established reputation and clinical performance. New entrants, like Journey Medical Corporation's Emrosi (Minocycline Hydrochloride), may also impact the market dynamics, but ORACEA's established market presence is likely to sustain its demand[1][2].

Supply Chain and Logistical Challenges

The supply of ORACEA is facing several challenges that could impact its availability and pricing:

Global Shipping Delays

Global shipping delays and logistical bottlenecks, exacerbated by incidents like the closure of the Port of Baltimore and geopolitical tensions, can hinder the prompt movement of Doxycycline Hydrochloride. These disruptions can lead to increased costs for pharmaceutical firms, which may be passed on to consumers[1].

Geopolitical Tensions

The conflict between Iran and Israel adds complexity to global trade, affecting logistics and maritime activities. This could result in delays in the exportation of pharmaceutical goods, including Doxycycline Hydrochloride, and increase transportation costs due to higher crude oil prices[1].

Financial Trajectory

The financial performance of ORACEA is influenced by several key factors:

Revenue and Market Share

ORACEA generates significant revenue, with market intelligence suggesting that it produces an estimated annual revenue of $128 million in the U.S. alone. This robust financial performance underscores the substantial demand for the drug[1].

Pricing Dynamics

The prices of Doxycycline Hydrochloride, including ORACEA, are expected to rise due to consistent demand from healthcare and pharmaceutical sectors, coupled with supply limitations. The potential easing of inflation in the U.S. and any escalation in geopolitical conflicts could further drive up prices[1].

Competitive Landscape

The rosacea treatment market is competitive, with various large multinationals and smaller companies vying for market share. ORACEA's position is strong, but it faces competition from new treatments and generic versions. The development and launch of novel treatments with improved efficiency and cost-effectiveness are key strategies in this market[4].

Market Growth and Projections

The rosacea treatment market, which includes ORACEA, is projected to grow at a CAGR of 6.5% from 2024 to 2032, reaching an estimated value of $3.7 billion by 2032. The antibiotic segment, where ORACEA is categorized, dominated the market in 2023, generating approximately $617.5 million in revenue[4].

Distribution and Sales Channels

The distribution of ORACEA is primarily through hospital pharmacies and retail pharmacies, with hospital pharmacies dominating the market share. This distribution network ensures wide availability and accessibility of the drug to patients[4].

Challenges and Opportunities

Regulatory Environment

The pharmaceutical industry is heavily regulated, and any changes in legislation or regulatory requirements can impact the sales and profitability of ORACEA. However, compliance with these regulations is crucial for maintaining market presence[2].

Innovation and New Product Launches

The launch of new products and innovations in the rosacea treatment market presents both opportunities and challenges. Companies like Galderma, which have delivered strong growth through innovation and commercial performance, set a high standard for competitors like ORACEA[3].

Patient Access and Reimbursement

Patient access rebates and reimbursement policies can affect the profitability of ORACEA. Ensuring broad market acceptance, including by government and third-party payors, is essential for sustained financial performance[2].

Key Takeaways

• Robust Demand: ORACEA faces consistent demand from the healthcare and pharmaceutical sectors.
• Supply Challenges: Global shipping delays, logistical bottlenecks, and geopolitical tensions impact the supply chain.
• Pricing Dynamics: Prices are expected to rise due to demand and supply imbalances.
• Competitive Landscape: The market is competitive, with new entrants and generic versions.
• Market Growth: The rosacea treatment market is projected to grow at a CAGR of 6.5% from 2024 to 2032.
• Distribution: Primarily distributed through hospital and retail pharmacies.

FAQs

Q: What is ORACEA used for?

ORACEA is used for the treatment of inflammatory lesions (papules and pustules) associated with rosacea in adult patients.

Q: What are the key factors driving the demand for ORACEA?

The demand for ORACEA is driven by the prevalence of rosacea, its clinical efficacy, and the lack of effective alternative treatments.

Q: How do global shipping delays and geopolitical tensions affect the supply of ORACEA?

Global shipping delays and geopolitical tensions can disrupt the supply chain, leading to increased costs and potential price hikes for ORACEA.

Q: What is the projected growth rate of the rosacea treatment market?

The rosacea treatment market is projected to grow at a CAGR of 6.5% from 2024 to 2032.

Q: Who are the main competitors in the rosacea treatment market?

The main competitors include large multinationals like Galderma, Journey Medical Corporation, and generic manufacturers like Lupin Limited.

Sources

1. ChemAnalyst: Increased Demand and Limited Supply to Push Up Doxycycline Hydrochloride Prices in the US.
2. Biospace: Journey Medical Corporation Announces U.S. FDA Approval of Emrosi (Minocycline Hydrochloride) Extended-Release Capsules.
3. Galderma: Galderma delivers strong FY 2022 growth driven by innovation and commercial performance.
4. Global Market Insights: Rosacea Treatment Market Size, Share & Analysis Report - 2032.
5. FDA: ORACEA - accessdata.fda.gov.