DORYX MPC Drug Patent Profile

Which patents cover Doryx Mpc, and when can generic versions of Doryx Mpc launch?

Doryx Mpc is a drug marketed by Mayne Pharma and is included in one NDA. There are four patents protecting this drug and five Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in DORYX MPC 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 Mpc

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

Summary for DORYX MPC

International Patents:	2
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Patent Applications:	438
Drug Prices:	Drug price information for DORYX MPC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DORYX MPC
What excipients (inactive ingredients) are in DORYX MPC?	DORYX MPC excipients list
DailyMed Link:	DORYX MPC at DailyMed

See drug prices for DORYX MPC

Pharmacology for DORYX MPC

Drug Class

Tetracycline-class Drug

Paragraph IV (Patent) Challenges for DORYX MPC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	60 mg and 120 mg	050795	1	2017-09-28
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	50 mg	050795	1	2015-11-05
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	80 mg	050795	1	2015-07-01
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	200 mg	050795	1	2014-05-19
DORYX MPC	Delayed-release Tablets	doxycycline hyclate	150 mg	050795	1	2008-12-19

US Patents and Regulatory Information for DORYX MPC

DORYX MPC is protected by four 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 MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016		RX	Yes	No	9,295,652		Y
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016		DISCN	Yes	No	9,511,031		Y
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016		RX	Yes	No	9,446,057		Y

Expired US Patents for DORYX MPC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016	6,958,161
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016	6,958,161

International Patents for DORYX MPC

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

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

DORYX MPC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DORYX MPC

Introduction to DORYX MPC

DORYX MPC, a delayed-release formulation of doxycycline hyclate, is a tetracycline-class antibiotic used to treat a variety of bacterial infections. It is marketed by Mayne Pharma and Warner Chilcott, and its indications include respiratory tract infections, specific bacterial infections, and even anthrax[2][4].

Market Context and Healthcare Spending

The pharmaceutical market, particularly the segment involving prescription drugs, is expected to see significant growth. Healthcare spending on prescription drugs is projected to increase from 14.5% of total healthcare spending in 2021 to 15.4% by 2026, translating to a rise from $625 billion to $875 billion over this period. This increase is largely attributed to new brand drugs with patent protections and increased utilization of existing high-price drugs[1].

Generic Entry and Market Impact

Generic drugs play a crucial role in reducing healthcare costs. The entry of generic versions of drugs like DORYX MPC can significantly lower drug prices. Studies have shown that drug prices decline after generic entry, with the decline being steeper when multiple generic entrants are present in the market. However, strategies such as "product hopping" by brand companies, where they introduce newly patented versions of the brand drug (e.g., extended-release formulations), can reduce the market size for generic entrants by up to 29% within the first year and more in subsequent years[1].

Patent Protection and Generic Competition

DORYX MPC is protected by several patents, which affect the timing and feasibility of generic competition. There are four patents protecting this drug, with two patent family members in two countries. The generic ingredient, doxycycline hyclate, has seen generic approvals, but the specific formulation of DORYX MPC remains under patent protection until these patents expire[5].

Financial Implications of Patent Protection

The presence of patents significantly influences the financial trajectory of DORYX MPC. As long as the patents remain in force, Mayne Pharma and Warner Chilcott can maintain a monopoly on the market, allowing them to set higher prices and maximize profits. Once the patents expire, generic competition can enter the market, leading to a decline in prices and revenues for the brand drug. This transition can result in substantial financial changes, as generic drugs typically capture a significant market share due to their lower prices[1][5].

Impact of Product Hopping

Product hopping, where the brand company introduces a new formulation (like the extended-release version of DORYX MPC), can delay generic entry and reduce the market share of generic competitors. This strategy can extend the brand's market exclusivity and maintain higher prices, but it also faces regulatory scrutiny. For instance, the U.S. government has shown interest in promoting competition and reducing drug prices through initiatives like the Comprehensive Plan for Addressing High Drug Prices[1].

Economic Ramifications of Precision Medicines

The pharmaceutical industry is increasingly focusing on precision medicines and drugs targeting small patient populations. While these developments can lead to higher prices due to the high value created for these specific patient groups, they also pose challenges for generic firms. The fixed costs of research and development are high, and the small patient population often makes it unprofitable for generic firms to enter these markets, leading to higher prices for these niche drugs[3].

Dosage and Pricing Strategies

The dosage and pricing strategies for DORYX MPC are critical in its market dynamics. The drug is available in 60 mg and 120 mg delayed-release tablets, with specific dosing recommendations for various infections. The pricing strategy must balance the need to maximize profits with the need to remain competitive, especially as generic versions become available. The Average Wholesale Price (AWP) and other pricing metrics are closely monitored to ensure the drug remains accessible while maintaining profitability[4].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of DORYX MPC. Approvals from regulatory bodies like the FDA are crucial for both the brand and generic versions of the drug. The FDA's approval process and subsequent monitoring ensure that the drug meets safety and efficacy standards, which can impact its market performance. Additionally, regulatory initiatives aimed at promoting competition and reducing drug prices can affect the financial trajectory of DORYX MPC[2][4].

Patient Access and Affordability

Patient access and affordability are key considerations in the market dynamics of DORYX MPC. As healthcare spending on prescription drugs increases, there is a growing need for affordable treatment options. Generic entry and competitive pricing strategies can enhance patient access, but they must be balanced against the need for pharmaceutical companies to recoup their investment in research and development[1].

Market Forecast and Sales

The market forecast for DORYX MPC is influenced by several factors, including the expiration of patents, the introduction of generic competitors, and changes in healthcare spending. While specific global sales figures for DORYX MPC are not readily available, the overall trend in the pharmaceutical market suggests that brand drugs will face increasing competition from generics, potentially leading to a decline in sales over time[5].

Key Takeaways

• Patent Protection: DORYX MPC is protected by several patents, which significantly impact its market dynamics and financial trajectory.
• Generic Entry: The entry of generic versions can lower drug prices, but product hopping strategies by brand companies can delay this process.
• Regulatory Environment: Regulatory approvals and initiatives to promote competition affect the drug's market performance.
• Pricing Strategies: Balancing profitability with accessibility is crucial in the pricing strategy for DORYX MPC.
• Patient Access: Enhancing patient access through affordable treatment options is a key consideration.

FAQs

Q1: What is DORYX MPC used for? DORYX MPC is used to treat various bacterial infections, including respiratory tract infections, specific bacterial infections, and anthrax[2][4].

Q2: How does generic entry affect the market for DORYX MPC? Generic entry typically leads to a decline in drug prices, but strategies like product hopping by brand companies can reduce the market size for generic entrants[1].

Q3: What is the impact of patent protection on DORYX MPC? Patent protection allows the brand company to maintain a monopoly, set higher prices, and maximize profits until the patents expire[5].

Q4: How does the regulatory environment influence DORYX MPC? Regulatory approvals and initiatives to promote competition can affect the drug's market performance and pricing strategies[2][4].

Q5: What are the financial implications of precision medicines for DORYX MPC? Precision medicines can lead to higher prices due to their high value for specific patient groups, but they also pose challenges for generic firms due to high development costs and small patient populations[3].

Sources

1. COST OF GENERIC DRUG DEVELOPMENT AND APPROVAL FINAL REPORT - ASPE.HHS.GOV
2. DORYX MPC Label - Accessdata.FDA.GOV
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER.ORG
4. CENTER FOR DRUG EVALUATION AND RESEARCH - Accessdata.FDA.GOV
5. DORYX Drug Patent Profile - DrugPatentWatch.com