US Patent 8,613,949: Aliskiren-Amlodipine Fixed-Dose Tablet Patent Scope and Landscape

US Patent 8,613,949 protects a specific monolayer tablet combining aliskiren and amlodipine with defined excipient ranges, manufacturing steps, and dissolution behavior. The patent is formulation-specific rather than a basic composition-of-matter patent for either active ingredient. Its commercial relevance is tied to Valturna, the Novartis aliskiren/amlodipine product, which was withdrawn from the US market in 2012. The patent’s projected expiration is approximately June 2030, subject to the recorded patent-term calculation and any terminal disclaimer or adjustment.

What does US Patent 8,613,949 claim?

The independent product claim requires a pharmaceutical oral fixed-dose combination in the form of a monolayer tablet containing:

Required element	Claim 1 requirement
Aliskiren or salt	10% to 45% by tablet weight
Amlodipine or salt	0.5% to 5% by tablet weight
Disintegrant	2% to 15%
Diluent	1% to 60%
Binder	0.1% to 20%
Lubricant	0.1% to 5%
Glidant	0.5% to 5%
Aliskiren dissolution at pH 2	60% or less at 10 minutes; 98% or less at 20 minutes
Amlodipine dissolution at pH 2	At least 50% at 20 minutes; at least 70% at 30 minutes

The percentages are calculated before any optional film coating. A product must satisfy every limitation of claim 1 to infringe that claim literally.

The patent therefore does not cover every aliskiren-amlodipine combination. It targets a particular formulation architecture intended to control the release profiles of two active ingredients with materially different formulation and dissolution characteristics.

How strong is the independent product claim?

Claim 1 has meaningful limitation density. A competing tablet would need to fall within the active-ingredient ranges, all five excipient categories, the monolayer-tablet requirement, and the specified dissolution windows.

The strongest limitations from a design-around perspective are:

The dual dissolution profile at pH 2.
The requirement for a monolayer tablet.
The combined excipient percentage ranges.
The aliskiren and amlodipine concentration ranges.

The dissolution limitations are particularly important. A competitor could potentially avoid literal infringement by using a formulation that produces a different release profile, a multilayer tablet, or a different dosage form. That design-around would still need to satisfy regulatory requirements and demonstrate bioequivalence or clinical equivalence, but it could reduce literal infringement risk.

The claim has potential vulnerability under ordinary validity doctrines because many of its elements are quantitative formulation ranges and routine manufacturing variables. The patent holder’s strongest position would arise from evidence that the claimed dissolution relationship was technically difficult to achieve and produced an unexpected benefit, such as improved stability, reproducibility, bioavailability, or tolerability.

What formulations are protected by the dependent claims?

The dependent claims narrow the formulation and manufacturing scope.

Claim	Added limitation
2	Aliskiren is in a wet-granulated form
3	Amlodipine is in a roller-compacted granulate
4	Aliskiren is 75 to 300 mg free-base equivalent per unit
5	Amlodipine is 1 to 20 mg per unit
6	Specified preparation process, including separate granulation, sieving, blending and compression
7	Aliskiren is the hemi-fumarate salt
8	Amlodipine is the besylate salt
9	Aliskiren is 150 mg or 300 mg free-base equivalent
10	Amlodipine is 5 mg or 10 mg
11	Narrower active and excipient ranges
12	Film coating is present
13	Film coating contains selected polymeric and other materials
14	Specific excipients are used

Claim 14 identifies the following conventional excipient system:

Crospovidone as disintegrant;
Microcrystalline cellulose as diluent;
Povidone as binder;
Magnesium stearate as lubricant; and
Colloidal silicon dioxide as glidant.

Claims 7 through 10 closely track commercially recognizable dose configurations. A 150 mg or 300 mg aliskiren formulation combined with 5 mg or 10 mg amlodipine would fall within the dosage limitations if the other claim requirements were met.

Does the patent cover Valturna?

Valturna contained aliskiren hemifumarate and amlodipine besylate. The approved strengths included aliskiren/amlodipine combinations corresponding to the dosage configurations recited in claims 9 and 10. The label identified the product as an oral tablet marketed by Novartis Pharmaceuticals Corporation.[2]

The patent claims are consistent with the technical profile of Valturna, but the claims must be analyzed independently from the product label. A marketed product infringes only if its actual composition, manufacturing process and dissolution profile satisfy the applicable claim limitations. The existence of the same active ingredients and nominal strengths is not sufficient by itself.

The strongest product-specific overlap would arise where a product has:

Aliskiren hemifumarate;
Amlodipine besylate;
150/5 mg, 150/10 mg, 300/5 mg or 300/10 mg strengths;
A monolayer tablet;
The claimed excipient system; and
The claimed pH 2 dissolution results.

When does US Patent 8,613,949 lose exclusivity?

The patent was issued on December 24, 2013. Its published priority and filing history indicate a PCT-based application with a priority date in 2009 and a US national-stage filing in 2011. On that basis, the ordinary patent term would extend approximately 20 years from the relevant nonprovisional or international filing date, producing an estimated expiration in 2030.[1]

Event	Date
Earliest reported priority	June 26, 2009
PCT or international filing period	2010
US national-stage filing	2011
US patent publication	2012
Patent grant	December 24, 2013
Estimated ordinary expiration	Approximately June 2030

The exact expiration date should be taken from the USPTO Patent Center term calculation, including any patent-term adjustment and terminal-disclaimer information. The issue date does not determine expiration.

Patent expiration would remove the US patent barrier created by US 8,613,949. It would not eliminate other possible barriers, including separate patents covering aliskiren, amlodipine, combination therapy, dosage regimens, manufacturing processes, crystalline forms, or other formulations.

What is the Orange Book status of the patent?

Valturna was withdrawn from the US market for commercial reasons in 2012. FDA stated that the withdrawal was not based on safety or efficacy concerns.[3] Because the reference product is discontinued, the commercial importance of any Orange Book listing is materially lower than it would be for an actively marketed product.

The Orange Book distinguishes between active and discontinued products and identifies patent and exclusivity information associated with approved drug applications.[4] A patent appearing in the patent record does not itself establish that a current ANDA applicant must address the patent. The relevant analysis depends on the status of the reference-listed drug, the patent listing, FDA’s regulatory records and the applicant’s filing pathway.

There is no current biologic-license or biosimilar pathway issue. Aliskiren and amlodipine are small-molecule drugs. A competitor would generally use an abbreviated new drug application or another small-molecule pathway rather than a biosimilar application.

Are there Paragraph IV challenges to US 8,613,949?

A Paragraph IV certification would be relevant only to an ANDA referencing an eligible listed drug and addressing a listed patent. The applicant would certify that the patent is invalid, unenforceable or would not be infringed by the proposed product.

Publicly available records do not establish a material, continuing Paragraph IV litigation program directed specifically at US 8,613,949. Valturna’s market withdrawal and limited commercial opportunity reduced the incentive for a conventional generic launch. The absence of a prominent reported case does not establish that the patent was never challenged, because some certifications and settlement activity may not generate extensive reported litigation.

For a product containing the claimed active ingredients, the main Paragraph IV positions would likely involve:

Failure to meet the pH 2 dissolution limitations;
Use of a multilayer tablet rather than a monolayer tablet;
Concentrations outside one or more claimed percentage ranges;
Use of an excipient outside the claimed category or range;
Non-infringing granulation or blending procedures;
Invalidity based on obviousness; and
Indefiniteness or lack of written description for the dissolution and percentage limitations.

What patent litigation affects the aliskiren-amlodipine combination?

The relevant enforcement risk is formulation litigation, not basic molecule litigation. Aliskiren’s core compound protection and amlodipine’s original compound protection are separate from this patent and are substantially older.

The litigation profile is limited by three factors:

Valturna was withdrawn.
The combination has not maintained a large current US commercial market.
The patent claims are narrow enough to permit formulation-based design-around strategies.

A future enforcement action would likely require extensive discovery into batch records, excipient quantities, granulation methods and dissolution testing. The pH 2 testing condition would be central. A plaintiff would need to establish that the accused product satisfies the claimed dissolution thresholds using an appropriate test method and representative commercial batches.

How does US 8,613,949 compare with the underlying active-ingredient patents?

Patent category	Covered subject matter	Relevance to a modern competitor
Aliskiren compound patents	Active pharmaceutical ingredient and related chemical subject matter	Historical protection; generally expired or near-expired relative to the formulation patent
Amlodipine compound patents	Amlodipine and pharmaceutically acceptable salts	Historical protection; original compound protection is expired
Combination patents	Use of aliskiren with calcium-channel blockers or other antihypertensives	May cover therapeutic combinations or dosing
US 8,613,949	Specific monolayer tablet, excipient ranges and dissolution profile	Formulation-specific barrier
Manufacturing patents	Granulation, compression, coating or process controls	May create additional infringement exposure
Regulatory exclusivity	FDA approval and market exclusivity	Product- and application-specific; separate from patent term

US 8,613,949 is therefore best characterized as a late-stage formulation patent. It does not recreate the underlying chemical exclusivity of either active ingredient.

What manufacturing and intellectual-property barriers remain?

The patent’s manufacturing claims are concentrated in claim 6 and the granulation-dependent claims 2 and 3.

Claim 6 requires a sequence involving:

Granulating aliskiren;
Granulating amlodipine;
Optional drying;
Sieving;
Optional addition of outer-phase excipients;
Mixing the respective granulates;
Screening;
Optional final blending;
Compression into a monolayer tablet; and
Optional film coating.

The claim uses process language that may raise product-by-process and claim-construction issues. A competitor that produces a tablet with the same final characteristics but uses direct compression, co-processing or a different granulation sequence may have a non-infringement position under claim 6. Claims 2 and 3 may still create exposure if the final product contains the specified granulate forms and the court treats the "obtainable by" language as imposing structural or process limitations.

The principal manufacturing barrier is not the use of any individual excipient. Crospovidone, microcrystalline cellulose, povidone, magnesium stearate and colloidal silicon dioxide are common pharmaceutical excipients. The barrier is the combination of excipients, processing sequence and dissolution outcome.

What generic launch scenarios exist?

Launch before patent expiration

A pre-expiration launch would require one of the following:

A successful Paragraph IV challenge;
A formulation outside the claims;
A settlement permitting an agreed launch date;
A license from the patent owner; or
A determination that the patent is not enforceable against the proposed product.

Launch after patent expiration

A post-expiration launch would face fewer patent-specific obstacles from US 8,613,949. The competitor would still need an FDA-acceptable reference product, a viable ANDA pathway and a commercially relevant market. Valturna’s discontinuation complicates the reference-product strategy and reduces expected revenue.

Authorized or licensed launch

Novartis could license the formulation technology or permit a third party to commercialize an equivalent product. No prominent public licensing transaction specifically tied to US 8,613,949 has been identified in the cited record.

What is the commercial exposure?

Valturna was withdrawn in 2012, so current direct revenue exposure is limited. The patent could still affect:

Reintroduction of the combination;
A new fixed-dose product;
A licensing transaction;
A formulation-development program;
A portfolio acquisition involving Novartis assets; or
A generic strategy using the combination as a development platform.

The commercial value of the patent is therefore option value rather than established current-product revenue. Its value increases if a sponsor can obtain a new approval or find a new market for combined renin-angiotensin and calcium-channel-blocker therapy. Its value decreases because both active ingredients are old, the combination’s commercial history is limited and alternative antihypertensive combinations are widely available.

Key Takeaways

US 8,613,949 is a formulation patent, not a basic aliskiren or amlodipine compound patent.
Claim 1 requires a monolayer tablet, defined active and excipient ranges, and a dual dissolution profile at pH 2.
Claims 2, 3 and 6 add wet granulation, roller compaction and a multi-step manufacturing sequence.
Claims 7 through 10 closely correspond to aliskiren hemifumarate, amlodipine besylate and commercially relevant dose strengths.
Claim 14 identifies a conventional excipient system: crospovidone, microcrystalline cellulose, povidone, magnesium stearate and colloidal silicon dioxide.
The estimated patent expiration is approximately June 2030, subject to the official USPTO term calculation.
Valturna was withdrawn in 2012, limiting current commercial exposure.
No material continuing Paragraph IV litigation specific to this patent is established in the cited public record.
Generic risk is primarily formulation-specific. A multilayer tablet, different dissolution profile or different manufacturing process could reduce literal infringement risk.
Biosimilar risk is not applicable because aliskiren and amlodipine are small-molecule drugs.
Any freedom-to-operate review must examine related combination, dosage-form, process and regulatory records in addition to US 8,613,949.

FAQs About US Patent 8,613,949

Does US 8,613,949 cover all aliskiren and amlodipine tablets?

No. It covers tablets meeting the specific structural, quantitative and dissolution limitations in the claims.

Does a 300 mg aliskiren and 10 mg amlodipine tablet automatically infringe?

No. The dose strengths overlap claims 9 and 10, but infringement also depends on the tablet structure, excipient ranges, manufacturing limitations and dissolution results.

Can a multilayer tablet avoid US 8,613,949?

A multilayer tablet would have a strong argument against the express monolayer limitation in claim 1. Other patents or claims could still apply.

Is a film-coated tablet outside the patent?

No. Claim 12 expressly covers a formulation with a film coating, and claim 13 identifies coating materials. The coating is calculated separately from the pre-coating tablet percentages.

Does withdrawal of Valturna invalidate the patent?

No. Product withdrawal does not by itself invalidate a patent. It reduces the patent’s commercial relevance and may affect the regulatory pathway for future generic development.

Sources

United States Patent and Trademark Office. (2013). US Patent No. 8,613,949, Pharmaceutical composition comprising aliskiren and amlodipine. https://patents.google.com/patent/US8613949B2/en
Novartis Pharmaceuticals Corporation. (2009). Valturna prescribing information. U.S. Food and Drug Administration.
U.S. Food and Drug Administration. (2012). FDA drug safety communication: Voluntary withdrawal of Valturna. https://www.fda.gov/
U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010		DISCN	No	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010		DISCN	No	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010		DISCN	No	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010		DISCN	No	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

PCT Information
PCT Filed	September 22, 2009	PCT Application Number:	PCT/US2009/057750
PCT Publication Date:	March 25, 2010	PCT Publication Number:	WO2010/033954

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	073384	⤷ Start Trial
Australia	2009292908	⤷ Start Trial
Brazil	PI0919350	⤷ Start Trial
Canada	2736257	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,613,949

Which drugs does patent 8,613,949 protect, and when does it expire?

Summary for Patent: 8,613,949