ATACAND HCT Drug Patent Profile

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

Atacand Hct is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in ATACAND HCT is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atacand Hct

A generic version of ATACAND HCT was approved as candesartan cilexetil; hydrochlorothiazide by PHARMOBEDIENT on December 4^th, 2012.

Summary for ATACAND HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	46
Patent Applications:	61
Drug Prices:	Drug price information for ATACAND HCT
What excipients (inactive ingredients) are in ATACAND HCT?	ATACAND HCT excipients list
DailyMed Link:	ATACAND HCT at DailyMed

See drug prices for ATACAND HCT

Recent Clinical Trials for ATACAND HCT

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

Sponsor	Phase
The University of Texas Health Science Center, Houston	Early Phase 1
BioHealthonomics Inc.	Phase 2
AgoneX Biopharmaceuticals, Inc.	Phase 2

See all ATACAND HCT clinical trials

Pharmacology for ATACAND HCT

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for ATACAND HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	32 mg/25 mg	021093	1	2009-03-06
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	16 mg/12.5 mg and 32 mg/12.5 mg	021093	1	2008-06-25

US Patents and Regulatory Information for ATACAND HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	AB	RX	Yes	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	AB	RX	Yes	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	AB	RX	Yes	Yes

Expired US Patents for ATACAND HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,958,961
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,703,110
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,721,263
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,958,961
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,958,961
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,721,263
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,703,110

International Patents for ATACAND HCT

See the table below for patents covering ATACAND HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	146779
Austria	227709
Australia	647469
Australia	7533191
Brazil	1100710
Canada	2040955	DERIVES DU BENZIMIDAZOLE, LEUR PRODUCTION ET LEUR UTILITE (BENZIMIDAZOLE DERIVATIVES, THEIR PRODUCTION AND USE)
Canada	2204290	DERIVES DU BENZIMIDAZOLE; PRODUCTION ET UTILISATION (BENZIMIDAZOLE DERIVATIVES, THEIR PRODUCTION AND USE)

Supplementary Protection Certificates for ATACAND HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0459136	SPC/GB97/018	United Kingdom		PRODUCT NAME: CANDESARTAN CILEXETIL OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK PL0017/0383 19970429; UK PL0017/0384 19970429; UK PL0017/0385 19970429; UK PL0017/0391 19970429; UK PL15561/0003 19970429; UK PL15661/0001 19970429; UK PL15661/0002 19970429; UK PL15661/0004 19970429
0459136	C970044	Netherlands		PRODUCT NAME: CANDESARTAN, DESGENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF VAN DE 1-(CYCLOHEXYLOXYCARBONYLOXY) ETHYLESTE R, IN HET BIJZONDER CILEXETILI CANDESARTANAS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 21703 - RVG 21706 19971013; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429
0459136	98C0016	Belgium		PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 19970429
0459136	8/1998	Austria		PRODUCT NAME: CANDESARTAN CILEXETIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-22232, 1-22233, 1-22235, 1-22236 19971119; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429
0459136	SZ 8/1998	Austria
0459136	19875004	Germany		PRODUCT NAME: WIRKSTOFF DES ARZNEIMITTELS BLOPRESS BZW. DES ARZNEIMITTELS ATACAND IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; NAT. REGISTRATION NO/DATE: 41261.00.00 41261.01.00 41261.02.00 41261.03.00 41294.00.00 41294.01.00 41294.02.00 41294.03.00 19971203 FIRST REGISTRATION: GROSSBRITANNIEN 15661/0001 15661/0002 15661/0003 15661/0004 19970429

ATACAND HCT Market Dynamics and Financial Trajectory (candesartan cilexetil + hydrochlorothiazide)

Last updated: July 25, 2026

ATACAND HCT (candesartan cilexetil 0.5/1/2/4 mg? and hydrochlorothiazide; marketed as fixed-dose combination) tracks the broader ARB plus diuretic category. Its near-term revenue path is dominated by (1) class-level uptake of angiotensin receptor blockers (ARBs) for hypertension, (2) competitive substitution within combination antihypertensives, and (3) patent and regulatory-exclusivity timing that determines when lower-cost generics can take share. In practice, the financial trajectory for an established fixed-dose combination is shaped more by category pricing pressure and payer contracting cycles than by incremental clinical differentiation.

Because no ATACAND HCT-specific financials, FDA exclusivity timeline, Orange Book status, patent estate dates, or current net sales figures are provided in the request, a complete and accurate market-and-financial trajectory cannot be produced to Bloomberg-grade standards without risking fabricated numbers.

Market dynamics for ATACAND HCT: what drives share, pricing, and formulary placement?
ATACAND HCT sits in a crowded antihypertensive landscape where prescribers and payers manage tolerability, dosing convenience, and cost per treated patient. For combination products, the key dynamics are:

• Switching behavior within hypertension drug classes
  ARBs compete with ACE inhibitors, other ARBs, calcium channel blockers, and combination pills that add diuretics (HCTZ and alternatives). Fixed-dose combinations reduce pill burden and can improve adherence, which tends to help formulary access early, but also accelerates price compression once generics launch.

• Payer contracting and gross-to-net pressure
  Established hypertension brands generally face rising rebates and incentive payments over time as generics enter and as payers negotiate “preferred” formulary tiers. Even without explicit new competitors, gross-to-net dilution often becomes the dominant revenue factor.

• Pricing sensitivity for older, widely treated populations
  Hypertension is heavily genericized in ARBs and diuretics. When the branded combination becomes cost-ineffective relative to available therapeutically equivalent generics, payer policies tend to shift patients toward lower net-cost options.

• Persistence and adherence as share protectors
  Combination products can hold onto patients who are stable on the same dosing regimen. That said, once lower-cost alternatives offer comparable dosing, churn increases.

Which competitors most affect ATACAND HCT’s market trajectory?
Within “ARB + diuretic” and broader antihypertensive combination categories, ATACAND HCT’s share exposure comes from two fronts:

• Generic ARB + HCTZ combinations
  Lower-cost fixed-dose combinations are often treated as interchangeable substitutes by payers when dosing equivalence and coverage align.

• Brand and branded generics across antihypertensive combos
  Other ARB combinations and ACE inhibitor/diuretic combinations can compete through formulary placement, patient experience, and contracting terms.

For a complete competitor map (drug-by-drug) tied to actual market share or prescribing, current formulary preference data and brand/generic launch dates are required. Those inputs are not present in the request, so no ranked or quantitative competitive impact can be provided.

What is ATACAND HCT’s sales and revenue trajectory pattern in mature antihypertensive markets?
Absent drug-specific net sales data, the mature trajectory pattern in the US for established branded antihypertensive combinations is:

1. Growth phase tied to initial penetration and managed care uptake
2. Mid-cycle stabilization as contracting tightens
3. Steep revenue decline around generic substitution and associated rebate escalation
4. Lower “floor” revenue if residual branded usage persists due to inertia, specific dosing strengths, or coverage exceptions
5. Continued erosion until the branded product becomes a “non-preferred” option for most payers

ATACAND HCT, as an established combination product, is typically expected to follow this framework once the product’s regulatory and patent barriers expire for its key dosage forms and marketed strengths.

When does ATACAND HCT lose exclusivity and face generic entry risk?
This requires the product’s FDA approvals (NDA or ANDA references), Orange Book listing status (active/inactive patents, expiration dates), and any relevant FDA exclusivities (3-year, 5-year, pediatric exclusivity). None of that is included in the request, so a correct exclusivity timetable and generic entry risk window cannot be produced.

How strong is the ATACAND HCT patent estate, and which patent types matter for market exclusivity?
For fixed-dose combinations like candesartan cilexetil + hydrochlorothiazide, key patent buckets that can affect launch timing include:

• Composition of matter for the active ingredient(s) and salts/solvates
• Combination-specific patents covering fixed-dose formulations
• Method-of-use patents related to treatment regimens and patient subgroups
• Formulation and manufacturing process patents that can create barrier to “AB-rated” generic substitution for particular strengths
• Patents tied to specific dosage forms and release characteristics

A defensible strength assessment requires exact patent numbers, remaining lives, assignees, claim scope summaries, and whether patents are listed in the Orange Book for each strength. Those inputs are not available in the request.

What is the Orange Book status of ATACAND HCT?
Orange Book status requires the exact listing page for ATACAND HCT (NDA number, dosage forms, patent list, and status). Without that, any statement about listed patents, expirations, or whether the product is currently protected would be speculative.

Has ATACAND HCT faced Paragraph IV challenges or generic litigation?
Paragraph IV challenges and litigation outcomes materially alter revenue and generic entry speed, but they must be tied to case dockets and publicly reported settlement terms. The request includes no ATACAND HCT litigation identifiers, no generic challenger names, and no settlement information. A litigation-driven timeline cannot be constructed without risking inaccuracies.

How does ATACAND HCT compare with other ARB + diuretic combination brands on market resilience?
A comparative market-resilience analysis needs for each comparator:

• branded vs generic share at the molecule-strength level
• net price and net-to-gross trends
• formulary access differences by PBM and payer segment
• exclusivity and patent calendars

No such data is included. Therefore, a credible cross-drug comparison cannot be made.

Commercial trajectory drivers specific to fixed-dose ARB/HCTZ combinations
Even without company-specific financials, the commercial drivers for ARB/HCTZ combinations are consistent:

• Dosing strength availability
  “Coverage” strengths often determine whether prescribers and payers can keep patients on the combo rather than splitting into components.

• Tolerability and clinical positioning
  Diuretic-related adverse events (electrolyte shifts, volume depletion) drive switching to alternate regimens. If an alternative formulation reduces these events, branded combos can hold share longer.

• Prior authorization and step edits
  These policies can delay conversion from brand to generic or between combination products, depending on payer strategy.

• Manufacturer contracting terms
  PBM and payer rebates determine the effective price differential versus generic substitutes.

What revenue exposure exists from strength-by-strength generic substitution scenarios?
Revenue exposure depends on:

• which strengths are protected by formulation and method patents
• whether challengers file for all strengths
• whether settlements carve out strengths
• whether “authorized generics” are used

No strength-level exclusivity or challenger filing scope is included in the request, so no scenario analysis can be completed.

Key Takeaways

• ATACAND HCT market dynamics are driven by hypertension class competition, payer contracting, and generic substitution timelines typical of mature branded combination antihypertensives.
• A credible financial trajectory for ATACAND HCT requires drug-specific inputs: Orange Book patent listings, exclusivity expirations, and any Paragraph IV/litigation outcomes, plus current and historical US net sales. Those inputs are not provided, so a complete and accurate trajectory cannot be stated.
• Commercial risk concentrates around fixed-dose strength coverage, rebate/gross-to-net compression, and the timing of generic entry permitted by the patent estate.

FAQs

1. What payer policy factors most affect branded ARB/HCTZ combination persistence?
   Formularies, prior authorization requirements, step edits, and rebate-driven preferred tier placement.

2. Do fixed-dose ARB/HCTZ combinations face slower switching than component dosing?
   Switching can be slower when patients are stable and dosing strengths remain covered, but price and coverage differences often accelerate substitution once generics are available.

3. How do Paragraph IV settlements typically influence branded combination revenue?
   Settlements can delay generic launch dates, sometimes by strength, and often affect whether an authorized generic enters earlier than a true Paragraph IV product.

4. What tends to matter most in Orange Book coverage for combination products?
   Whether listed patents map to combination composition/formulation claims for each dosage form and whether they remain unexpired for the strengths marketed.

5. What is the most important metric for evaluating future ATACAND HCT revenue risk?
   Net price trajectory (gross-to-net dilution) paired with the timing and breadth of generic substitution by strength.

References (APA)

1. FDA Orange Book database: https://www.accessdata.fda.gov/scripts/cder/daf/ (access required for ATACAND HCT listing details).
2. FDA Drugs@FDA database: https://www.accessdata.fda.gov/scripts/cder/daf/ (access required for ATACAND HCT approval and NDA/label history).