ACYCLOVIR; HYDROCORTISONE - Generic Drug Details

What are the generic sources for acyclovir; hydrocortisone and what is the scope of patent protection?

Acyclovir; hydrocortisone is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ACYCLOVIR; HYDROCORTISONE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	ACYCLOVIR; HYDROCORTISONE at DailyMed

Recent Clinical Trials for ACYCLOVIR; HYDROCORTISONE

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

Sponsor	Phase
Assiut University	Phase 2
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all ACYCLOVIR; HYDROCORTISONE clinical trials

Pharmacology for ACYCLOVIR; HYDROCORTISONE

Drug Class	Corticosteroid Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	Corticosteroid Hormone Receptor Agonists DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ACYCLOVIR; HYDROCORTISONE

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ACYCLOVIR; HYDROCORTISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009		RX	Yes	Yes

Expired US Patents for ACYCLOVIR; HYDROCORTISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009

ACYCLOVIR; HYDROCORTISONE Market Analysis and Financial Projection

Last updated: February 15, 2026

What are the current market dynamics for ACYCLOVIR and HYDROCORTISONE?

ACYCLOVIR

• Market Size: The global acyclovir market was valued at approximately USD 1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2030.
• Key Drivers: Increasing prevalence of herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections drives demand. The affordability of generic acyclovir enhances adoption, especially in emerging markets.
• Market Share: Major pharmaceutical companies such as Teva, Mylan, and Sandoz dominate the generic space, providing cost-competitive options.
• Regulatory Trends: Stringent regulatory pathways for biosimilars and branded drugs influence market entry timelines. Patents for branded acyclovir formulations have expired, encouraging generic proliferation.

HYDROCORTISONE

• Market Size: The global hydrocortisone market was valued at roughly USD 600 million in 2022. It is expected to grow at a CAGR of 3.8% up to 2030.
• Key Drivers: Rising incidence of inflammatory and autoimmune disorders, such as rheumatoid arthritis and ulcerative colitis, increase hydrocoritsone demand.
• Market Share: Large players include Pfizer, Sandoz, and Sun Pharmaceutical Industries, with a focus on both topical and injectable forms.
• Regulatory Trend: Different formulations face varied regulatory barriers—topical products typically experience faster approval cycles than systemic injections.

Comparative Market Dynamics

Parameter	ACYCLOVIR	HYDROCORTISONE
Valuation 2022	USD 1.2 billion	USD 600 million
CAGR 2023-2030	4.5%	3.8%
Main indications	HSV, VZV infections	Inflammatory, autoimmune disorders
Regulatory environment	Generic proliferation, biosimilar rules	Varied by formulation; topical faster

How is the financial trajectory shaping for these drugs?

Aciclovir

• Revenue Trends: Revenues have stabilized in established markets due to generic competition but remain robust in emerging markets with increasing infection rates. Year-over-year growth remains modest, around 2-3%, for leading generic manufacturers.
• Profitability: Margin compression occurs due to price erosion driven by generics. However, companies benefit from large volume sales.
• R&D Investment: Limited research focus; the pathway mainly involves manufacturing efficiency and formulation improvements.

Hydrocortisone

• Revenue Trends: Growth driven by expanding application scope and aging populations. Topical forms maintain stable sales, while injectable formulations see incremental gains.
• Profitability: Higher margins for branded formulations; generics face competitive pricing pressures.
• R&D Investment: Focus on developing novel delivery systems and combination therapies to sustain market share.

Investment Considerations

• The patent expirations for branded acyclovir create opportunities for generic market entrants, leading to price declines but volume increases.
• Hydrocortisone’s demand is sensitive to regulatory approvals of new formulations, with topical versions offering lower regulatory hurdles compared to systemic routes.
• Emerging markets contribute significantly to revenue growth, especially for cost-effective generic versions.

What are the key policies impacting this market?

• Patent Laws: Expiration of patents stimulates generic entry, reducing prices for acyclovir.
• Pricing Regulations: Governments in emerging markets enforce price controls, impacting revenues.
• Regulatory Approvals: Accelerated approvals for biosimilars and generics facilitate market entry but require compliance with evolving standards.
• Reimbursement Policies: Insurance coverage and government programs influence the adoption rate of formulations, particularly for hydrocortisone.

Which factors influence future trajectories?

• Infection Prevalence: Rising global herpes virus cases augment acyclovir demand.
• Autoimmune Disease Incidence: Growth in autoimmune conditions sustains hydrocortisone's market need.
• Technological Innovation: Novel delivery platforms (e.g., patches, sustained-release systems) could boost product differentiation.
• Regulatory Changes: Streamlining approval processes may accelerate market entry for new formulations.

Final insights on the market trajectory

• Acyclovir will see moderate growth driven by emerging markets and new formulations. Pricing pressures from generics persist, but volume growth offers revenue stability.
• Hydrocortisone maintains steady growth amid expanding indications and aging demographics, with innovation likely to provide competitive edges.

Key Takeaways

• Acyclovir’s market is mature, with growth mainly in emerging markets and through new formulations.
• Hydrocortisone benefits from a broader scope of applications, supporting ongoing demand.
• Patent expirations and regulatory reforms critically shape future competitiveness.
• Cost pressures in generic markets demand efficiency and innovation.
• Demographic shifts and rising autoimmune/infectious disease prevalence underpin demand trends.

FAQs

1. What is the primary driver for acyclovir market growth? Rising herpes virus infections, especially in developing regions, contribute to increased acyclovir demand.

2. Are branded formulations still relevant for hydrocortisone? Yes. Branded formulations often command higher margins and face less price erosion compared to generics.

3. How do regulatory changes affect acyclovir and hydrocortisone markets? They influence entry timelines, especially for biosimilars and novel formulations, impacting competitive dynamics.

4. What technological developments could influence future hydrocortisone products? Advances include transdermal patches and sustained-release formulations enhancing compliance and efficacy.

5. Which emerging markets present the most growth opportunity? India, China, and Latin America exhibit expanding demand for both drugs owing to increasing disease prevalence and lower manufacturing costs.

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Citations

1. MarketWatch, 2022. "Global Acyclovir Market Forecast."
2. Research and Markets, 2022. "Hydrocortisone Market Analysis."
3. PubMed, 2022. "Epidemiology of Herpes Virus Infection."
4. WHO, 2023. "Autoimmune Diseases and Global Burden."