AMTURNIDE Drug Patent Profile

Which patents cover Amturnide, and when can generic versions of Amturnide launch?

Amturnide is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.

Summary for AMTURNIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	20
DailyMed Link:	AMTURNIDE at DailyMed

US Patents and Regulatory Information for AMTURNIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No

Expired US Patents for AMTURNIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010

International Patents for AMTURNIDE

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

Country	Patent Number	Title	Estimated Expiration
Austria	183997
Australia	1642095
Australia	1642195

Supplementary Protection Certificates for AMTURNIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1602370	91563	Luxembourg		91563, EXPIRES: 20231028
1602370	CA 2009 00010	Denmark		PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
1602370	C300385	Netherlands		PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028

Last updated: July 20, 2026

AMTURNIDE market dynamics and financial trajectory: sales drivers, pricing pressure, exclusivity timeline, and competitive threats

AMTURNIDE (aliskiren/amlodipine) is an antihypertensive combination that entered a market already shaped by tighter safety scrutiny of renin inhibitor class therapy and by aggressive branded-to-generic and branded-to-better-validated-therapy switching. The drug’s financial trajectory is dominated by (1) class-level uptake constraints after safety communications, (2) payer and formulary compression toward better-tolerated and guideline-favored regimens, and (3) the time-boxed value of combination exclusivity before generic substitution risk rises for either component and any protected fixed-dose combinations.

What is AMTURNIDE and how does its market segment behave?

AMTURNIDE is a fixed-dose combination of aliskiren and amlodipine used for hypertension management. Its demand is tied to three market forces common to cardiovascular fixed-dose combinations:

1. Formulary design and tiering
   Medicare Part D and commercial plans often steer away from less-preferred branded combinations when (a) equivalent monotherapies and lower-priced combinations exist and (b) safety communications raise prior-authorization friction.

2. Guideline and evidence alignment
   Hypertension prescribing shifts toward regimens supported by outcomes in large, contemporary cohorts. In practice, prescribers adopt combinations when they improve tolerability and adherence without adding safety risk.

3. Switching economics after generic entry
   When multiple components become generic, fixed-dose branded combinations face “unbundling” risk. Even when a branded FDC has remaining patent life, payer discounts and step therapy can accelerate loss of share.

Who buys AMTURNIDE and how do incentives shape uptake?

• Hospital and health-system formularies: procurement favors cost-effective alternatives and protocols for antihypertensives.
• Community prescribers: rely on patient-specific titration history, tolerability, and local formulary constraints.
• Payers: push step therapy, especially when class safety concerns increase utilization management.

What market dynamics drove AMTURNIDE revenue growth or decline?

AMTURNIDE’s market dynamics are best understood through class and combination adoption constraints.

Renin inhibitor class tightening reduced addressable demand

Aliskiren faced major safety scrutiny related to cardiovascular and renal outcomes in high-risk populations. Class-wide communications drove formulary caution and prescriber hesitancy. In fixed-dose combinations, that caution transfers immediately because the combination’s value proposition depends on aliskiren.

Amlodipine’s mature, low-cost competition reduced combination pricing power

Amlodipine is a well-established, highly generic antihypertensive. When one component is cost-pressured, the branded combination’s incremental value must be compelling for payers and clinicians to sustain premium pricing.

Fixed-dose combination preference tends to be selective

Clinicians prefer fixed-dose combos when they simplify titration and improve adherence. But payer and safety dynamics can cause the market to prioritize alternate combinations (e.g., ACE inhibitor or ARB-based pairs, or combinations aligned with post-communication safety expectations).

Unbundling risk after generic erosion

Once aliskiren or amlodipine generics reach widespread adoption, payers increasingly support lower-cost regimens by prescribing components separately. That reduces the protected “combo premium” even before a dedicated FDC generic launches.

When does AMTURNIDE lose exclusivity, and what does that mean for generic threats?

A defensible exclusivity timeline requires linked, jurisdiction-specific patent and regulatory listings. This request cannot be completed accurately because no Orange Book, patent publication list, or FDA exclusivity data for AMTURNIDE was provided in the prompt, and producing them from memory would be unreliable.

What generally happens at the end of exclusivity for antihypertensive FDCs

• Orange Book patent expiry triggers Paragraph IV or Section viii(b) ANDA activity for generics where bioequivalence and labeling support exist.
• Remaining method-of-use or formulation patents can delay launch even if the base composition patents expire.
• Payer behavior accelerates erosion: even before generic approval, discounting and formulary tier movement can compress net prices.

What is the Orange Book status of AMTURNIDE and which patents control it?

This cannot be produced without the Orange Book listing for the exact NDA product strength and dosage form(s). Patent-by-patent mapping is required to answer “which patents protect” and “how many patents cover” and to separate composition, formulation, and method-of-use claims.

How strong is the patent estate for AMTURNIDE and what are litigation risks?

A litigation-risk assessment requires:

• identified asserted patents,
• listed NDA or FDA correspondence,
• any Hatch-Waxman litigation docket outcomes or settlement terms,
• and the remaining life of those patents by jurisdiction.

No such data is available in the prompt, and generating it from general knowledge would fail accuracy requirements.

Which companies are challenging AMTURNIDE with generics or biosimilars?

AMTURNIDE is a small-molecule antihypertensive; biosimilar dynamics do not apply. To identify generic challengers, Paragraph IV filers, and any settlements, the Paragraph IV and Orange Book history for the specific NDA is required. The prompt provides no such information.

How does AMTURNIDE compare with competing antihypertensive fixed-dose combinations?

A high-confidence comparison requires product-level net pricing, formulary position, and branded-to-generic share by molecule and by combination. The prompt provides no market share or payer-formulary data.

Expected competitive fault lines (directional)

• ALT (alternative low-cost regimen) dominance: generic amlodipine plus generic aliskiren (or other standard add-ons) can reduce the willingness to pay for AMTURNIDE.
• Safety-driven substitution: after class safety communications, prescribers may switch toward regimens with stronger perceived safety profiles.
• Guideline-aligned combinations: ARB/ACE inhibitor-based combinations often carry higher adoption when outcomes evidence is preferred.

What FDA pathway and label constraints affect AMTURNIDE’s commercial trajectory?

This requires AMTURNIDE’s NDA history, label indications, and any boxed warnings, contraindications, or population restrictions. Without the product label history, an accurate regulatory commercialization impact analysis cannot be produced.

What settlement agreements or Paragraph IV outcomes changed AMTURNIDE’s market path?

Settlement terms and launch timing require litigation and settlement documentation tied to the specific NDA patents. No such data is included in the prompt.

How do pricing and reimbursement dynamics shape AMTURNIDE net sales?

Pricing compression typically accelerates when

• one or more components are broadly generic,
• payers tighten prior authorization for less-favored branded options,
• and competitors offer comparable BP reduction with lower total cost.

Net sales drivers that matter most for a cardiovascular FDC

• WAC-to-net discounts: commercial rebate pressure is higher when therapeutic alternatives exist.
• Formulary access: net sales depend on tier placement and persistence.
• Script volume vs persistence: switching after adverse events or safety communications can reduce persistence and refill rates.

AMTURNIDE financial trajectory: what do we know from sales data?

This request requires actual financial figures (revenue, prescription trends, market share, and year-by-year net sales) from filings, earnings call transcripts, or syndicated datasets. The prompt does not provide sales data, and generating it without citations would violate the requirement for hard data.

Key Takeaways

• AMTURNIDE’s market dynamics are constrained by renin inhibitor class safety scrutiny and amlodipine’s mature low-cost competition, making sustained premium pricing harder in payer settings.
• The likely revenue path is downward or stagnant once formulary restrictions and unbundling pressure rise, especially as generic availability increases.
• A precise exclusivity, Orange Book control set, litigation mapping, and generic challenge forecast cannot be completed without product-specific regulatory and patent listing inputs.

FAQs

1. How do safety communications for renin inhibitors affect fixed-dose antihypertensive combinations like AMTURNIDE?
2. What payer levers (tiering, prior authorization, step therapy) most impact branded cardiovascular fixed-dose combinations?
3. What commercial impact does unbundling have when one AMTURNIDE component becomes generic before the fixed-dose combination?
4. How do Paragraph IV challenges typically affect launch timing and pricing for antihypertensive NDAs?
5. What label restrictions or contraindications most influence hypertension combination prescribing patterns?

References

No sources were provided in the prompt, and no Orange Book, label, or sales dataset citations were supplied.