DORYX Drug Patent Profile

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

Doryx is a drug marketed by Mayne Pharma and Warner Chilcott and is included in three NDAs. There are four patents protecting this drug.

This drug has two patent family members in two countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Doryx

A generic version of DORYX was approved as doxycycline hyclate by EPIC PHARMA LLC on November 8^th, 1982.

Summary for DORYX

International Patents:	2
US Patents:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	438
Drug Prices:	Drug price information for DORYX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DORYX
What excipients (inactive ingredients) are in DORYX?	DORYX excipients list
DailyMed Link:	DORYX at DailyMed

See drug prices for DORYX

See drug sales revenues for DORYX

Pharmacology for DORYX

Drug Class

Tetracycline-class Drug

US Patents and Regulatory Information for DORYX

DORYX is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	DORYX	doxycycline hyclate	CAPSULE, DELAYED RELEASE;ORAL	050582-002	Aug 13, 2001		DISCN	Yes	No
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-002	May 6, 2005		DISCN	Yes	No			Y
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-006	Dec 19, 2014		DISCN	Yes	No			Y
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016		RX	Yes	No			Y

Expired US Patents for DORYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-003	Jun 20, 2008
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-006	Dec 19, 2014
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-005	Apr 11, 2013
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-002	May 6, 2005

International Patents for DORYX

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

Country	Patent Number	Title	Estimated Expiration
Australia	2005299253	Improved tabletting process
World Intellectual Property Organization (WIPO)	2006045152

DORYX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DORYX

Introduction

DORYX, a brand name for the antibiotic doxycycline hyclate, is a significant player in the pharmaceutical market, particularly in the treatment of various bacterial infections. Here, we will delve into the market dynamics and financial trajectory of DORYX, highlighting key trends, challenges, and future projections.

Market Size and Growth

The oral doxycycline hyclate market, which includes DORYX, has been experiencing steady growth. As of 2022, the market size was valued at USD 4.2 billion and is projected to grow to USD 9.2 billion by 2032, with a compound annual growth rate (CAGR) that reflects increasing demand for effective antibiotics[1].

Product Types and Applications

DORYX is available in various forms, including tablets, capsules, and oral suspensions. The drug is widely used for treating intestinal infections, respiratory tract infections, urinary tract infections, and other bacterial infections. The versatility of its formulations and broad application spectrum contribute to its market appeal[1].

Distribution Channels

The distribution of DORYX is primarily through hospital pharmacies, retail pharmacies, and online pharmacies. Mayne Pharma, a key player in the distribution of DORYX, has strengthened its distribution network by bringing in-house the sales and marketing of this product. This strategic move has significantly improved the product's performance, as seen in the company's financial reports[2].

Regional Market Performance

The market for DORYX is global, with significant presence in North America, Europe, Asia-Pacific, and the rest of the world. Mayne Pharma's strategic investments in manufacturing facilities in the USA and Australia have enhanced the company's capability to expand its product offerings and improve regional market performance[2].

Financial Performance of Mayne Pharma

Mayne Pharma's financial performance has been positively impacted by the acquisition and in-house distribution of DORYX. In the 2015 financial year, the company reported revenue of $141.4 million, with underlying EBITDA of $36.4 million. The inclusion of earnings from the DORYX acquisition contributed to a gross profit margin increase from 52.4% to 56.6%[2].

Impact of In-House Distribution

By taking full control of the distribution of DORYX, Mayne Pharma saw a significant improvement in the second half of the 2015 financial year. Revenue increased by 37% to $81.9 million, and underlying EBITDA rose by 49% to $21.8 million. This shift in distribution strategy has been a key factor in the financial success of the product[2].

Investment and Expansion

Mayne Pharma has made strategic investments in its manufacturing facilities to enhance its capability and capacity. A $65 million investment in a new greenfield facility in Greenville, NC, USA, and investments in Salisbury, South Australia, are aimed at expanding development, manufacturing, and packaging operations. These investments are crucial for sustaining the growth trajectory of DORYX and other products in the company's portfolio[2].

Challenges and Risks

Despite the positive financial trajectory, the pharmaceutical industry, including the market for DORYX, faces several challenges. The high cost of bringing a new drug to market, estimated at around $2.6 billion with a development timeline of 10 to 15 years, and the low probability of success (around 10%) pose significant risks. Additionally, the decline in return on investment (ROI) for pharmaceutical R&D, partly due to stricter regulatory hurdles and shorter exclusivity periods, is a concern[3].

Regulatory and Market Dynamics

The pharmaceutical market is heavily regulated, and changes in regulatory environments can significantly impact the financial performance of drugs like DORYX. The introduction of generic or biosimilar competitors can lead to a rapid decline in sales for brand-name drugs once they lose patent protection. This was evident in the case of Humira, which lost patent exclusivity in 2023 and saw a significant drop in sales[3].

Public Health and Market Demand

The growing global burden of chronic diseases, including infections that DORYX treats, drives the demand for effective antibiotics. The emergence of new infectious diseases and the threat of antimicrobial resistance (AMR) further emphasize the need for continued investment in antibiotic research and development. Initiatives like the AMR Action Fund aim to incentivize investment in this critical area[3].

Competitive Landscape

The market for antibiotics is competitive, with several brands and generics available. DORYX, however, has a strong market presence due to its efficacy and the strategic distribution and marketing efforts by Mayne Pharma. The company's focus on controlling the manufacture, distribution, and sales of key product franchises has helped in improving the performance of DORYX[2].

Future Projections

Given the projected growth of the oral doxycycline hyclate market, DORYX is expected to continue its upward financial trajectory. The increasing demand for antibiotics, coupled with Mayne Pharma's strategic investments and improved distribution channels, positions DORYX for sustained growth in the coming years[1].

Key Takeaways

• Market Growth: The oral doxycycline hyclate market, including DORYX, is projected to grow significantly by 2032.
• Distribution Strategy: In-house distribution has improved the financial performance of DORYX.
• Regulatory Challenges: The pharmaceutical industry faces challenges from regulatory hurdles and shorter exclusivity periods.
• Public Health Demand: Growing demand for effective antibiotics due to chronic diseases and AMR.
• Competitive Landscape: DORYX maintains a strong market presence through strategic marketing and distribution.

FAQs

Q1: What is the current market size of the oral doxycycline hyclate market? The oral doxycycline hyclate market was valued at USD 4.2 billion in 2022[1].

Q2: How is DORYX distributed? DORYX is distributed primarily through hospital pharmacies, retail pharmacies, and online pharmacies[1].

Q3: What was the impact of in-house distribution on Mayne Pharma's financial performance? In-house distribution of DORYX led to a 37% increase in revenue and a 49% increase in underlying EBITDA for Mayne Pharma in the second half of the 2015 financial year[2].

Q4: What are the major challenges facing the pharmaceutical industry, including DORYX? The industry faces high development costs, low success rates for new drugs, and declining ROI due to regulatory hurdles and shorter exclusivity periods[3].

Q5: How does the growing global burden of chronic diseases affect the demand for DORYX? The increasing burden of chronic diseases drives the demand for effective antibiotics like DORYX, contributing to its market growth[3].

Sources

1. Market Research Future: Oral Doxycycline Hyclate Market Size, Trends, Report 2032.
2. Annual Reports: Mayne Pharma Annual Report 2015.
3. DrugBank Blog: Investment Trends in Pharmaceutical Research and Development.