VIBRAMYCIN Drug Patent Profile

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

Vibramycin is a drug marketed by Pfizer and is included in four NDAs.

The generic ingredient in VIBRAMYCIN is doxycycline calcium. There are twenty-eight drug master file entries for this compound. Additional details are available on the doxycycline calcium profile page.

Summary for VIBRAMYCIN

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	177
Clinical Trials:	22
Patent Applications:	4,036
Drug Prices:	Drug price information for VIBRAMYCIN
Drug Sales Revenues:	Drug sales revenues for VIBRAMYCIN
DailyMed Link:	VIBRAMYCIN at DailyMed

See drug prices for VIBRAMYCIN

See drug sales revenues for VIBRAMYCIN

Recent Clinical Trials for VIBRAMYCIN

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

Sponsor	Phase
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
University of Iowa	Phase 4

See all VIBRAMYCIN clinical trials

US Patents and Regulatory Information for VIBRAMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	VIBRAMYCIN	doxycycline	FOR SUSPENSION;ORAL	050006-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	VIBRAMYCIN	doxycycline hyclate	CAPSULE;ORAL	050007-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	VIBRAMYCIN	doxycycline hyclate	CAPSULE;ORAL	050007-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Pfizer	VIBRAMYCIN	doxycycline hyclate	INJECTABLE;INJECTION	050442-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	VIBRAMYCIN	doxycycline hyclate	INJECTABLE;INJECTION	050442-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	VIBRAMYCIN	doxycycline calcium	SUSPENSION;ORAL	050480-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

EU/EMA Drug Approvals for VIBRAMYCIN

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

Market Dynamics and Financial Trajectory for VIBRAMYCIN (Doxycycline Hyclate)

Introduction to VIBRAMYCIN

VIBRAMYCIN, known generically as doxycycline hyclate, is a widely used antibiotic belonging to the tetracycline class. It is indicated for the treatment of various bacterial infections, including respiratory, urinary, and intestinal infections, among others[3].

Market Size and Growth

The market for oral doxycycline hyclate is substantial and growing. As of 2022, the oral doxycycline hyclate market was valued at USD 4.2 billion. It is projected to grow from USD 4.6 billion in 2023 to USD 9.2 billion by 2032, indicating a significant increase in demand and market size over the next decade[1].

Product Types and Applications

VIBRAMYCIN is available in various forms, including tablets, capsules, and oral suspensions. These formulations cater to different patient needs and preferences. The drug is used to treat a wide range of infections, such as:

• Respiratory Tract Infections: Caused by microorganisms like Mycoplasma pneumoniae.
• Urinary Tract Infections: Including those caused by susceptible bacteria.
• Intestinal Infections: Such as those caused by Rickettsiae.
• Other Infections: Including Rocky Mountain spotted fever, typhus fever, and acne vulgaris[3].

Distribution Channels

The distribution of VIBRAMYCIN occurs through several channels, each playing a crucial role in its market dynamics:

• Hospital Pharmacy: A significant channel, especially for severe infections requiring hospitalization.
• Retail Pharmacy: The most common channel for outpatient prescriptions.
• Online Pharmacy: Increasingly popular due to convenience and accessibility[1].

Regional Market Analysis

The global market for doxycycline hyclate is segmented into several regions:

• North America: This region is a major consumer of doxycycline hyclate, driven by a well-established healthcare system and high demand for antibiotics.
• Europe: Another significant market, with a strong presence of pharmaceutical companies.
• Asia-Pacific: A rapidly growing market due to increasing healthcare expenditure and a large population.
• Rest of the World: Includes other regions with varying levels of market penetration and growth potential[1].

Financial Performance of Antibiotics

The financial performance of antibiotics, including doxycycline hyclate, is influenced by several factors:

• Revenue Comparison: Unlike blockbuster drugs in other therapeutic areas, antibiotics generally have lower revenue profiles. For example, the cumulative revenue for new antibiotic drugs launched between 2010 and 2020 was $714.3 million, significantly lower than drugs like Humira or Crestor[2].
• Generic Dominance: The majority of antibiotic sales come from generic, off-patent products, which are low-priced and widely used. This reduces the revenue potential for brand-name antibiotics[2].

Top Selling Antibiotics

Doxycycline, in its generic form, is among the top-selling antibiotics in the U.S.:

• Annual Revenue: In 2022, generic doxycycline generated approximately $149.7 million in annual revenue, placing it among the top ten selling antibiotics in the U.S.[2].

Economic Challenges for Novel Antibiotics

The development and commercialization of new antibiotics face several economic challenges:

• Low Revenue Potential: The commercial opportunity for novel antibiotics is generally low, leading to lower expected acquisition prices and returns for investors.
• High Development Costs: The cost of developing an antibiotic is high, with a risk-adjusted cost per stage that must be factored into financial models.
• Incentives for Investors: To attract investors, a yearly pull incentive of $260 million over ten years has been proposed, totaling approximately $2.6 billion, to provide a sufficient financial incentive[2].

Pricing and Cost Considerations

The pricing of VIBRAMYCIN and other antibiotics is critical for their market dynamics:

• Pricing Strategy: The pricing of antibiotics must balance profitability with affordability and accessibility. Generic pricing tends to be lower, affecting the overall revenue of brand-name products.
• Cost of Development: The high costs associated with developing new antibiotics, including the costs of each stage from discovery to approval, impact the pricing and profitability of these drugs[2].

Market Forecast and Trends

The market for doxycycline hyclate is expected to grow significantly over the next decade, driven by:

• Increasing Demand: Growing demand for antibiotics due to rising infections and the need for effective treatments.
• Expanding Distribution Channels: The rise of online pharmacies and improved retail pharmacy networks will enhance accessibility.
• New Indications: Potential new indications and uses for doxycycline hyclate could further boost market growth[1].

Regulatory and Clinical Considerations

The use of VIBRAMYCIN is regulated and guided by clinical guidelines:

• Indications and Usage: VIBRAMYCIN should only be used to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Side Effects and Superinfections: The drug can lead to side effects and superinfections, necessitating careful monitoring and appropriate therapy[5].

Conclusion

The market for VIBRAMYCIN (doxycycline hyclate) is characterized by significant growth potential, driven by increasing demand and expanding distribution channels. However, the financial trajectory of antibiotics is complex, influenced by low revenue potential, high development costs, and the dominance of generic products.

Key Takeaways

• Growing Market Size: The oral doxycycline hyclate market is projected to grow to USD 9.2 billion by 2032.
• Diverse Applications: VIBRAMYCIN is used to treat a wide range of bacterial infections.
• Regional Variations: North America is the largest consumer of doxycycline hyclate.
• Economic Challenges: Novel antibiotics face low revenue potential and high development costs.
• Regulatory Considerations: Use of VIBRAMYCIN must adhere to clinical guidelines to prevent misuse and superinfections.

FAQs

Q1: What is the projected market size of the oral doxycycline hyclate market by 2032? The oral doxycycline hyclate market is projected to grow to USD 9.2 billion by 2032[1].

Q2: Which region is the largest consumer of doxycycline hyclate? North America is the largest consumer of doxycycline hyclate globally[4].

Q3: What are the common forms of VIBRAMYCIN available in the market? VIBRAMYCIN is available in tablets, capsules, and oral suspensions[3].

Q4: Why do novel antibiotics generally have lower revenue profiles compared to other medicines? Novel antibiotics have lower revenue profiles due to the dominance of generic, off-patent products and the high development costs associated with bringing new antibiotics to market[2].

Q5: What is the recommended dosage of VIBRAMYCIN for treating uncomplicated gonococcal infections? For uncomplicated gonococcal infections, VIBRAMYCIN 100 mg is recommended to be taken orally twice daily for seven days, along with co-treatment with an appropriate cephalosporin or quinolone[3].

Sources

1. Market Research Future, "Oral Doxycycline Hyclate Market Size, Trends, Report 2032".
2. Harvard Kennedy School, "Sizing A Market Entry Reward for the Development of New Antibiotics".
3. Pfizer, "VIBRAMYCIN® (doxycycline calcium or doxycycline hyclate)".
4. ChemAnalyst, "Doxycycline Hydrochloride Market Size, Share & Forecast 2034".
5. Pfizer Medical Information, "VIBRAMYCIN® (doxycycline calcium or doxycycline hyclate)".