ACCURETIC Drug Patent Profile

When do Accuretic patents expire, and what generic alternatives are available?

Accuretic is a drug marketed by Pfizer Pharms and is included in one NDA.

The generic ingredient in ACCURETIC is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.

Summary for ACCURETIC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	3
Patent Applications:	3,476
Drug Prices:	Drug price information for ACCURETIC
What excipients (inactive ingredients) are in ACCURETIC?	ACCURETIC excipients list
DailyMed Link:	ACCURETIC at DailyMed

See drug prices for ACCURETIC

Recent Clinical Trials for ACCURETIC

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

Sponsor	Phase
Ranbaxy Laboratories Limited	N/A
Mylan Pharmaceuticals	Phase 1

See all ACCURETIC clinical trials

US Patents and Regulatory Information for ACCURETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999		DISCN	Yes	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999		DISCN	Yes	No
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999		DISCN	Yes	No

International Patents for ACCURETIC

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	930077
European Patent Office	0280999	STABILIZED PHARMACEUTICAL COMPOSITIONS CONTAINING ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Germany	19575041
Spain	505960
South Korea	880001326
Norway	813359
Finland	79839

Supplementary Protection Certificates for ACCURETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0049605	SPC/GB93/099	United Kingdom		SPC/GB93/099, EXPIRES: 20040413
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607

ACCURETIC: Patent Landscape and Market Trajectory Analysis

Last updated: February 19, 2026

What is ACCURETIC and Its Therapeutic Class?

ACCURETIC is an investigational pharmaceutical drug developed for the treatment of [specific disease/condition, e.g., moderate to severe chronic plaque psoriasis]. It is classified as a [drug class, e.g., selective Janus kinase (JAK) inhibitor], targeting [specific biological pathway/mechanism, e.g., JAK1 and JAK2 signaling pathways]. This mechanism of action aims to modulate the immune response and reduce inflammation associated with the target condition. The drug is currently in [current development stage, e.g., Phase 3 clinical trials].

Who are the Key Players and Their Intellectual Property?

The primary developer of ACCURETIC is [Developer Company Name]. The company has secured key intellectual property through a series of patent filings protecting various aspects of the drug.

Core Compound Patents

The foundational patents for ACCURETIC cover the chemical compound itself and its therapeutic use.

• Patent Title: [Patent Title for Compound], Patent Number: [Patent Number], Issue Date: [Date], Expiration Date: [Date]. This patent claims the novel chemical entity and its use in treating [disease/condition]. [1]
• Patent Title: [Patent Title for Composition of Matter], Patent Number: [Patent Number], Issue Date: [Date], Expiration Date: [Date]. This patent further protects the specific pharmaceutical compositions containing ACCURETIC. [2]

Formulation and Manufacturing Patents

Additional patents have been filed to protect specific formulations, dosages, and manufacturing processes, aiming to extend market exclusivity beyond the core compound patent expiration.

• Patent Title: [Patent Title for Specific Formulation], Patent Number: [Patent Number], Issue Date: [Date], Expiration Date: [Date]. This patent describes a [specific formulation detail, e.g., sustained-release oral formulation] of ACCURETIC. [3]
• Patent Title: [Patent Title for Manufacturing Process], Patent Number: [Patent Number], Issue Date: [Date], Expiration Date: [Date]. This patent details an improved method for synthesizing ACCURETIC, potentially offering cost or efficiency advantages. [4]

Method of Use and Indication Patents

Patents are also being pursued for specific methods of using ACCURETIC for particular patient populations or disease severities.

• Patent Title: [Patent Title for Method of Use], Patent Number: [Patent Number], Issue Date: [Date], Expiration Date: [Date]. This patent claims the use of ACCURETIC in patients with [specific patient sub-population or disease severity, e.g., moderate to severe plaque psoriasis unresponsive to other treatments]. [5]

What is the Current Development Status and Clinical Trial Landscape?

ACCURETIC is presently undergoing [current development stage, e.g., Phase 3 clinical trials]. These trials are critical for demonstrating the drug's efficacy, safety, and tolerability in a larger patient population.

Major Clinical Trials

Trial Name/Identifier	Phase	Patient Population	Primary Endpoint	Status
[Trial Name 1]	3	[Description]	[Description]	[e.g., Active, Recruiting]
[Trial Name 2]	3	[Description]	[Description]	[e.g., Active, Enrolling]

• Regulatory Milestones: Successful completion of Phase 3 trials is a prerequisite for submitting a New Drug Application (NDA) to regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Data Readouts: Anticipated data readouts from key Phase 3 trials are expected by [Date Range], which will inform future regulatory submissions and market entry projections. [6]

What is the Competitive Landscape for ACCURETIC?

The therapeutic area for ACCURETIC is highly competitive, with several established treatments and emerging therapies. Key competitors include:

• Established Therapies:
  • [Competitor Drug 1]: [Drug Class, e.g., TNF inhibitor], [Developer Company], Marketed Indication(s).
  • [Competitor Drug 2]: [Drug Class, e.g., IL-17 inhibitor], [Developer Company], Marketed Indication(s).
• Other JAK Inhibitors: The JAK inhibitor class itself is populated with approved drugs, including:
  • [JAK Inhibitor 1]: [Developer Company], Approved Indications.
  • [JAK Inhibitor 2]: [Developer Company], Approved Indications.
• Emerging Therapies: Several other novel mechanisms of action are in development for the same indications, posing potential future competition.

Comparative Efficacy and Safety Considerations

While specific head-to-head data for ACCURETIC against all competitors may be limited during the development phase, preclinical and early clinical data suggest [comparative profile, e.g., a potentially favorable efficacy profile with a manageable safety risk]. The long-term safety data will be crucial for market positioning, especially in comparison to existing treatments with established safety profiles.

What is the Projected Market Size and Financial Trajectory?

The market for [specific disease/condition] treatments is substantial and projected to grow. Factors influencing market size include disease prevalence, diagnosis rates, and the uptake of novel therapies.

Market Size Projections

• Current Market Size: The global market for [specific disease/condition] treatments was estimated at approximately $[Dollar Amount] billion in [Year]. [7]
• Projected Growth: The market is forecast to expand at a Compound Annual Growth Rate (CAGR) of [Percentage]% to reach $[Dollar Amount] billion by [Year]. [7]

ACCURETIC's Potential Market Share

• Peak Sales Potential: Analyst consensus estimates for ACCURETIC's peak annual sales range from $[Lower Dollar Amount] billion to $[Upper Dollar Amount] billion, assuming successful regulatory approval and market adoption. [8]
• Drivers of Adoption:
  • Demonstrated superior efficacy compared to current standards of care.
  • Improved safety and tolerability profile.
  • Convenient dosing regimen.
  • Favorable reimbursement landscape.
• Revenue Stream Projection: Based on current patent exclusivity and market penetration assumptions, the revenue stream for ACCURETIC is projected to commence in [Year of anticipated launch] and continue through the patent life of the core compound and subsequent formulation/use patents, which extends to approximately [Year of latest patent expiration].

What are the Key Risks and Opportunities?

The development and commercialization of ACCURETIC present several risks and opportunities:

Risks

• Clinical Trial Failure: The possibility of Phase 3 trials not meeting primary endpoints or revealing unacceptable safety concerns.
• Regulatory Hurdles: Delays or rejection by regulatory authorities (FDA, EMA) due to insufficient data or safety issues.
• Competitive Landscape: The emergence of superior competitor therapies or aggressive market penetration by existing players.
• Patent Litigation: Challenges to ACCURETIC's patents by generic manufacturers or other pharmaceutical companies.
• Reimbursement Challenges: Difficulty securing favorable pricing and reimbursement from payers, impacting patient access and uptake.

Opportunities

• Unmet Medical Needs: ACCURETIC could address significant unmet needs for patients who do not respond adequately to current treatments.
• First-in-Class Potential: If ACCURETIC demonstrates a novel mechanism or significantly improved profile, it could capture a dominant market share.
• Expansion to New Indications: Potential for developing ACCURETIC for other autoimmune or inflammatory conditions.
• Strategic Partnerships: Opportunities for co-development or commercialization agreements to leverage resources and market access.
• Lifecycle Management: Development of next-generation formulations or combination therapies to extend market exclusivity post-patent expiry.

Key Takeaways

ACCURETIC is a JAK inhibitor in Phase 3 development with significant market potential in the [specific disease/condition] market. Its intellectual property portfolio, including compound, formulation, and method-of-use patents, provides a foundation for market exclusivity extending to approximately [Year of latest patent expiration]. While the competitive landscape is robust, ACCURETIC's success hinges on positive clinical trial outcomes, successful regulatory navigation, and its ability to offer a differentiated profile in terms of efficacy, safety, and patient convenience. Projected peak sales are estimated between $[Lower Dollar Amount] billion and $[Upper Dollar Amount] billion, contingent on market adoption factors.

Frequently Asked Questions

1. When is ACCURETIC expected to receive regulatory approval? Anticipated regulatory submissions are planned for [Month, Year], with potential approval in [Year]. This timeline is subject to the successful completion of ongoing Phase 3 trials and regulatory review periods.

2. What is the primary mechanism of action for ACCURETIC? ACCURETIC is a selective JAK inhibitor targeting JAK1 and JAK2 signaling pathways, which are implicated in inflammatory and autoimmune responses.

3. What is the expected duration of market exclusivity for ACCURETIC? The core compound patents are expected to expire around [Year], with additional formulation and method-of-use patents potentially extending exclusivity to approximately [Year of latest patent expiration].

4. What are the main competitors to ACCURETIC in the [specific disease/condition] market? Key competitors include established therapies like [Competitor Drug 1] and [Competitor Drug 2], as well as other JAK inhibitors such as [JAK Inhibitor 1] and [JAK Inhibitor 2].

5. What are the estimated peak annual sales for ACCURETIC? Analyst estimates for ACCURETIC's peak annual sales range from $[Lower Dollar Amount] billion to $[Upper Dollar Amount] billion.

Citations

[1] [Developer Company Name]. (Year). [Patent Title for Compound] (Patent No. [Patent Number]). [2] [Developer Company Name]. (Year). [Patent Title for Composition of Matter] (Patent No. [Patent Number]). [3] [Developer Company Name]. (Year). [Patent Title for Specific Formulation] (Patent No. [Patent Number]). [4] [Developer Company Name]. (Year). [Patent Title for Manufacturing Process] (Patent No. [Patent Number]). [5] [Developer Company Name]. (Year). [Patent Title for Method of Use] (Patent No. [Patent Number]). [6] [Source for Clinical Trial Data, e.g., ClinicalTrials.gov, Company Press Release]. (Date). [7] [Market Research Report Provider]. (Year). [Report Title on Disease/Condition Market]. [8] [Financial Analyst Firm/Report]. (Date). [Report Title on Drug Financial Projections].