US Patent 9,023,893: Claim Scope, Aliskiren-Hydrochlorothiazide Coverage, and Patent Landscape

US Patent 9,023,893 covers a pharmaceutical composition containing a renin inhibitor in hemi-fumarate form, hydrochlorothiazide, and a carrier. The claims are directed to a fixed-combination or co-administered antihypertensive product, not to the renin inhibitor or hydrochlorothiazide individually. Claim 1 is the commercial core. Claims 2 and 3 add therapeutic-use limitations but do not materially broaden the composition coverage.

The supplied claim language indicates potential relevance to aliskiren hemifumarate plus hydrochlorothiazide products, including the Tekturna HCT product family. The patent’s practical value depends on the identity of “formula (I),” the patent’s earliest effective filing date, any terminal disclaimer or patent-term adjustment, FDA listing status, and whether the claims remain enforceable.

What does US Patent 9,023,893 cover?

The patent covers a composition comprising three required categories of components:

A renin inhibitor corresponding to formula (I), present as a hemi-fumarate.
Hydrochlorothiazide.
A carrier.

Claim 1 uses the transitional term “comprising.” That term generally permits the presence of additional ingredients, including excipients, stabilizers, coatings, buffers, binders, disintegrants, lubricants, other active ingredients, and manufacturing residues, provided the claimed components are present.[1]

The claim is therefore broader than a claim limited to a particular tablet strength, dosage ratio, formulation process, release profile, or excipient system.

Claim 1 element analysis

Claim element	Scope implication
“A pharmaceutical composition”	Covers a finished dosage composition and potentially other pharmaceutical dosage forms, depending on the specification and construction
“Renin inhibitor of formula (I)”	Limits the claim to the specific chemical genus or compound defined by formula (I) in the patent
“As a hemi-fumarate”	Requires the renin inhibitor to be present in the claimed salt form or in a form legally equivalent to that salt
“Hydrochlorothiazide”	Requires HCTZ as a second active pharmaceutical ingredient
“A carrier”	Requires a pharmaceutical carrier, but does not appear to require a particular excipient or dosage form
“Comprising”	Allows additional ingredients and active substances

The most important limitation is the identity of formula (I). The quoted claims do not reproduce that formula. If formula (I) is aliskiren, the claim is directed to aliskiren hemifumarate plus HCTZ. If formula (I) covers a broader chemical genus, the claim could extend beyond aliskiren, subject to the specification and prosecution history.

How broad is the composition claim?

Claim 1 is composition-focused and potentially covers:

Immediate-release tablets
Capsules
Powder blends
Granules
Oral suspensions
Multiparticulate dosage forms
Fixed-dose combination products
Separate dosage units packaged for combined administration, if treated as one pharmaceutical composition under the specification
Products containing additional antihypertensive agents

The claim does not expressly require:

A specific dose of the renin inhibitor
A specific dose of HCTZ
A particular molar or weight ratio
A particular salt or polymorph of HCTZ
A tablet
A single dosage unit
A specific release profile
A particular carrier
A particular manufacturing process
A specific hypertension patient population

A product that contains the claimed renin inhibitor salt and HCTZ in a conventional pharmaceutical carrier could fall within Claim 1 even if it uses different excipients, different strengths, a different tablet coating, or a different manufacturing process.

Does the claim cover separate dosage units?

Claim 1 does not expressly require that the renin inhibitor and HCTZ be physically combined in a single tablet. The phrase “a pharmaceutical composition comprising” ordinarily favors a single composition containing both actives. Claim 3 expressly addresses “simultaneous separate or sequential use,” which may support coverage of a kit, co-packaged product, or treatment regimen involving separate dosage units.

The scope would depend on:

The patent’s specification;
The definition of “composition”;
Whether Claim 3 is interpreted as a method-of-use claim or a product-use limitation;
Prosecution statements concerning separate administration;
Whether the accused product is sold as one composition, a kit, or separately prescribed products.

What does Claim 2 add?

Claim 2 covers the composition of Claim 1 “for the treatment of hypertension.”

As a dependent claim, Claim 2 incorporates every limitation of Claim 1 and adds the hypertension treatment purpose. It does not cover:

Aliskiren or another renin inhibitor alone;
HCTZ alone;
The combination for non-hypertension indications;
A composition lacking the claimed hemi-fumarate;
A composition without a carrier.

Claim 2 may provide method-of-use value, but its incremental scope is narrower than Claim 1. For a conventional antihypertensive product, the hypertension limitation may be relatively easy to satisfy. The practical enforcement question would be whether the product is labeled, promoted, prescribed, or reasonably intended for hypertension treatment.

What does Claim 3 add?

Claim 3 covers the Claim 1 composition for “simultaneous separate or sequential use.”

This language is significant because it attempts to reach administration formats in which:

The two active ingredients are taken at the same time but from separate dosage units;
The ingredients are administered at different times;
The treatment uses a staged regimen;
The components are supplied separately but intended for combined antihypertensive therapy.

Claim 3 does not appear to require a particular interval between administration of the two agents. It also does not specify which component must be administered first.

The phrase “simultaneous separate or sequential use” can create claim-construction issues. Courts may examine whether it describes:

A composition packaged for separate or sequential use;
A therapeutic kit;
A method of treating hypertension;
A product claim with a functional limitation; or
A second-medical-use style limitation adapted to U.S. claim practice.

The prosecution history is important because amendments or arguments distinguishing prior art could narrow the meaning of “separate” and “sequential.”

Which products are potentially relevant?

If formula (I) is aliskiren, the most relevant commercial product category is the aliskiren/HCTZ combination.

Product or product type	Potential relevance
Tekturna HCT	Directly relevant if it contains aliskiren hemifumarate and HCTZ
Generic aliskiren/HCTZ tablets	Potential direct infringement risk if the required salt and composition elements are present
Aliskiren tablets plus separate HCTZ tablets	Potential Claim 3 relevance, depending on packaging, labeling, and claim construction
Aliskiren/valsartan products	Not within the quoted claims because valsartan is not HCTZ
HCTZ combination products without the claimed renin inhibitor	Outside Claim 1
Aliskiren products using a different salt or free form	Potential non-infringement position, subject to salt-equivalence and claim construction
Compounded or hospital-prepared combinations	Fact-specific risk under composition, inducement, and contributory-infringement theories

Tekturna HCT was approved by the FDA as a combination of aliskiren and hydrochlorothiazide for hypertension.[2] FDA labeling identifies aliskiren hemifumarate as the active ingredient source for aliskiren products.[3]

What formulation features are protected?

The quoted claims provide broad formulation coverage but limited formulation-specific protection. They do not expressly claim:

A particular tablet hardness;
A dissolution profile;
A bilayer tablet;
An enteric coating;
A controlled-release matrix;
A specified particle size;
A particular polymorph;
A defined excipient combination;
A manufacturing temperature or granulation method.

The carrier limitation may nevertheless exclude a neat active-ingredient mixture or a non-pharmaceutical preparation. In a conventional oral tablet, the carrier requirement would likely be satisfied by excipients such as microcrystalline cellulose, lactose, crospovidone, magnesium stearate, or coating materials, depending on the patent’s disclosure.

The absence of a dose or ratio limitation increases breadth but can create validity exposure if earlier publications disclose aliskiren hemifumarate and HCTZ in a pharmaceutical composition. The key prior-art questions are whether the combination was disclosed, whether the specific salt was disclosed, and whether the claimed composition would have been obvious to a skilled person.

What is the likely patent landscape around the claims?

The relevant patent estate can be divided into five groups.

Renin-inhibitor compound patents

These patents cover the active renin inhibitor itself, including:

The chemical compound;
Salt forms;
Stereochemical forms;
Polymorphs;
Pharmaceutical compositions containing the compound;
Processes for preparing the compound.

A compound patent can block commercialization even if US 9,023,893 expires, while US 9,023,893 can create a separate combination-product barrier after the compound patent has expired.

Combination patents

US 9,023,893 is a combination patent based on the inclusion of HCTZ with the claimed renin inhibitor. Other combination patents may cover:

Aliskiren plus HCTZ;
Aliskiren plus an angiotensin receptor blocker;
Aliskiren plus a calcium-channel blocker;
Aliskiren plus other diuretics;
Specific dose ratios;
Fixed-dose tablet formulations;
Separate or sequential administration.

A generic applicant must assess each unexpired patent that is listed against the relevant FDA product and each non-listed patent that could support an infringement action.

Formulation and solid-state patents

Separate patents may cover:

Particular aliskiren salt forms;
Crystal forms;
Particle-size distributions;
Dissolution-enhancing formulations;
Film-coated tablets;
Combination tablets;
Manufacturing processes;
Stability improvements.

These patents can create launch risk even where the broad combination claim is invalid, expired, or not listed in the Orange Book.

Method-of-use patents

Claim 2 is a method-of-use style limitation directed to hypertension. Method patents may also cover:

Specific hypertension populations;
Renal impairment;
Diabetic patients;
Dose escalation;
Combination therapy after inadequate monotherapy;
Cardiovascular-risk reduction;
Avoidance of particular adverse events.

A generic applicant may address such patents through a Paragraph IV certification, a section viii carve-out, or a label design that omits the patented use, depending on the patent and FDA listing.

Manufacturing patents

Process patents can cover:

Preparation of the hemi-fumarate;
Salt formation;
Crystallization;
Purification;
Granulation;
Tablet compression;
Coating;
Packaging and stability control.

A manufacturing patent may be relevant even if the finished product does not disclose the process. Discovery may arise through process evidence, ANDA certification, inspection records, or manufacturing-site information.

What is the Orange Book status?

The Orange Book status cannot be determined from the quoted claims alone. The patent number, claim text, and FDA listing status are separate records.

For an Orange Book analysis, the relevant questions are:

Issue	Relevance
Listed drug	Whether the patent is listed against Tekturna HCT or another NDA
Patent use code	Whether the FDA listing identifies hypertension treatment or another use
Expiration date	Whether the patent remains an effective barrier
Pediatric extension	Whether six additional months were added
Patent-term adjustment	Whether the term was extended for USPTO delay
Terminal disclaimer	Whether the term is tied to another patent
NDA holder certification	Whether an ANDA applicant filed Paragraph IV
30-month stay	Whether litigation delayed approval
Delisting or correction	Whether the patent remains in the current Orange Book

FDA’s Orange Book identifies approved drug products, patent listings, use codes, and exclusivity information, but the Orange Book is not a complete inventory of every potentially enforceable patent.[4]

When does US Patent 9,023,893 lose exclusivity?

The patent issued on May 5, 2015. The expiration date cannot be calculated reliably from the issue date or the quoted claims. U.S. patent term generally runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, patent-term extension, and other statutory rules.[5]

The critical term variables are:

Earliest effective nonprovisional filing date;
Continuation or divisional relationship;
Patent-term adjustment;
Terminal disclaimer;
Patent-term extension under 35 U.S.C. § 156;
Pediatric exclusivity;
Any post-grant or litigation-based change in enforceability.

The patent’s issue date is therefore not its expiration date. A reliable exclusivity timeline must use the USPTO patent record and any corresponding Orange Book entry.

What Paragraph IV risks exist?

A generic applicant seeking approval for an aliskiren/HCTZ product could face Paragraph IV issues if US 9,023,893 or related patents are listed against the reference product.

Potential certification positions include:

The patent has expired.
The patent will expire before commercial launch.
The proposed product does not infringe.
The claims are invalid.
The patent is not applicable to the proposed dosage form or labeling.
The patent is not properly listed against the reference product.

The strongest non-infringement arguments would likely focus on:

Use of a non-claimed salt form;
Absence of the formula (I) compound;
Absence of HCTZ;
Lack of a pharmaceutical carrier;
Separate products not meeting the composition limitation;
Labeling that omits the claimed hypertension use.

The strongest validity arguments would likely address:

Anticipation by prior combination disclosures;
Obviousness based on renin-inhibitor and diuretic combination therapy;
Written-description support for the formula (I) genus;
Enablement across the full scope of formula (I);
Indefiniteness concerning “separate” or “sequential” use.

How strong is the patent estate?

The claim set is commercially meaningful but technically concentrated.

Strength factor	Assessment
Composition breadth	High, because Claim 1 lacks dose, ratio, and formulation restrictions
Dependence on formula (I)	High, because the exact chemical definition controls coverage
Salt specificity	Moderate to high; the hemi-fumarate limitation creates a design-around path
Formulation coverage	Moderate; broad carrier language but few formulation details
Method-of-use coverage	Moderate; hypertension is commercially relevant but potentially easy to design around through labeling
Separate/sequential coverage	Fact-dependent and vulnerable to claim-construction disputes
Generic vulnerability	Potentially significant if the prior art disclosed the specific salt and HCTZ combination
Biosimilar relevance	None in the conventional sense because aliskiren and HCTZ are small molecules, not biologics

A company evaluating a generic launch should treat the patent as a combination-product risk rather than as a primary active-ingredient patent. A company developing a competing hypertension product could reduce exposure by using a different renin-inhibitor salt, avoiding HCTZ, using a different therapeutic combination, or separating products in a manner outside the properly construed claims. Each route requires technical and legal validation.

What litigation and settlement issues matter?

Relevant litigation review should include:

ANDA litigation involving Tekturna HCT;
Paragraph IV notices concerning aliskiren/HCTZ;
Declaratory-judgment actions;
Patent-listing disputes;
Injunction proceedings;
Settlement agreements involving generic launch dates;
License agreements covering aliskiren, HCTZ, or the combination;
Any terminal-disclaimer or ownership issues affecting enforceability.

The claim text alone does not establish that US 9,023,893 was litigated, settled, licensed, or enforced. Assignment records also matter because ownership and standing must be established before an infringement claim can proceed.

Key Takeaways

US Patent 9,023,893 is directed to a composition combining a hemi-fumarate renin inhibitor, hydrochlorothiazide, and a carrier.
Claim 1 is the principal commercial claim and is broad because it has no express dose, ratio, tablet, excipient, or release-profile limitation.
Claim 2 targets hypertension treatment and may create method-of-use exposure for labeled antihypertensive products.
Claim 3 attempts to reach simultaneous, separate, or sequential administration.
The exact scope depends heavily on the undisclosed formula (I), specification definitions, and prosecution history.
The patent does not necessarily cover the renin inhibitor or HCTZ individually.
The principal generic design-around issues are salt selection, omission of HCTZ, separate-product structure, and labeling.
Orange Book listing, patent expiration, Paragraph IV activity, litigation, and settlements cannot be established from the quoted claims alone.
The patent should be analyzed together with active-ingredient, salt, formulation, method-of-use, and manufacturing patents.

FAQs

Does US Patent 9,023,893 cover aliskiren alone?

No. The quoted Claim 1 requires both the claimed hemi-fumarate renin inhibitor and hydrochlorothiazide, together with a carrier.

Does the patent cover valsartan combinations?

Not under the quoted claims. Valsartan is not hydrochlorothiazide and does not satisfy the HCTZ limitation.

Can a generic avoid the patent by using a different aliskiren salt?

Potentially. The claim expressly requires the renin inhibitor “as a hemi-fumarate.” The result depends on whether the proposed salt is outside the claim and whether other related patents apply.

Does a separate aliskiren tablet plus a separate HCTZ tablet infringe?

It may raise Claim 3 issues, but the answer depends on whether the products are supplied, labeled, or used for simultaneous separate or sequential administration and how the court construes “composition” and “use.”

Is this patent relevant to biosimilar approval?

No. Aliskiren and hydrochlorothiazide are small-molecule drugs. The relevant regulatory pathway is the ANDA pathway, not the biosimilar pathway under the Public Health Service Act.

References

United States Patent and Trademark Office. (2024). Manual of Patent Examining Procedure § 2111.03: Transitional phrases. https://www.uspto.gov/web/offices/pac/mpep/
U.S. Food and Drug Administration. (2008). FDA approves Tekturna HCT for high blood pressure. https://www.fda.gov/
U.S. Food and Drug Administration. (2023). Tekturna HCT prescribing information. https://www.accessdata.fda.gov/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
United States Code. (2024). 35 U.S.C. §§ 154, 156, and 271. https://uscode.house.gov/

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0028151.9	Nov 17, 2000

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1602370	⤷ Start Trial	91563	Luxembourg	⤷ Start Trial
European Patent Office	1602370	⤷ Start Trial	CA 2009 00010	Denmark	⤷ Start Trial
European Patent Office	1602370	⤷ Start Trial	C300385	Netherlands	⤷ Start Trial
European Patent Office	1602370	⤷ Start Trial	09C0020	France	⤷ Start Trial
European Patent Office	1602370	⤷ Start Trial	SPC/GB09/024	United Kingdom	⤷ Start Trial
European Patent Office	1602370	⤷ Start Trial	2009/010	Ireland	⤷ Start Trial
European Patent Office	1915993	⤷ Start Trial	C300625	Netherlands	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,023,893

Summary for Patent: 9,023,893