When do the patents on ANGIOMAX RTU expire, and when will ANGIOMAX RTU go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	⤷ 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.	>Exclusivity Expiration

Last updated: July 14, 2026

Angiomax RTU (bivalirudin) investment scenario and patent/Exclusivity fundamentals

Angiomax RTU (bivalirudin) is a legacy, short-acting anticoagulant with a patent landscape dominated by composition-of-matter and process/formulation patents that already matured years ago, shifting the investment case to (1) ongoing FDA-listed demand in cardiology settings, (2) defensibility from manufacturing/process and method-of-use patent remnants rather than exclusivity, and (3) competitive pressure from lower-cost anticoagulants. The commercial risk is structural: bivalirudin is not a typical long-cycle growth story, and its value is driven by procedure volume, guideline cycles, hospital formularies, and substitution dynamics.

What makes the investment case actionable is that Angiomax RTU is no longer an exclusivity-driven asset in most markets. The core investor questions are therefore about residual “economic exclusivity” (contracting and channel behavior), the strength of remaining enforceable IP that could slow generic or authorized generic entry, and whether any regulatory or labeling changes create a new wedge for higher priced positioning.

Data table: investment fundamentals snapshot (U.S. focus)

Item	What to evaluate	Why it matters for investment
Regulatory status	Whether Angiomax RTU is the sole FDA-approved injectable bivalirudin labeling owner and how other products are coded	Drives generic substitution likelihood and pricing pressure
Patent posture	Whether any unexpired Orange Book-listed patents still exist for Angiomax RTU in the specific dosage form (RTU) and route (IV)	Determines time window for exclusivity-like economics
Litigation history	Whether any Paragraph IV or enforcement actions occurred and outcome timing	Sets entry barriers for generics/authorized generics
Procurement dynamics	Hospital group purchasing and contracting with bivalirudin suppliers	Can preserve margin even after generic availability
Competitive landscape	Substitution to heparin plus GP IIb/IIIa inhibitors, DOACs (where appropriate), or other IV anticoagulants	Impacts volume and net price
Product life cycle	Any changes in usage patterns after major clinical practice shifts	Alters TAM growth assumptions

What patents protect Angiomax RTU (bivalirudin) in the U.S.?

A complete, investment-grade patent estate analysis requires Orange Book patent identifiers tied to the exact FDA product listing for Angiomax RTU (not just bivalirudin broadly), including patent numbers, assignees, expiration dates, and listed claims categories (composition, method of use, formulation, manufacturing). Without that mapping to the RTU listing, it is not possible to state which patents still protect the marketed RTU product or how long remaining enforceability lasts.

Core investment implication: If Angiomax RTU’s remaining Orange Book listings have already expired (common for legacy bivalirudin products), the “patent defensibility” investment thesis collapses into either (a) contract-based economics or (b) residual process/method enforcement that may not be reflected in Orange Book composition/formulation listings.

When does Angiomax RTU lose exclusivity and when do its patents expire?

Exclusivity and patent expiry for Angiomax RTU must be computed from the Orange Book listing for the specific FDA NDA/strength/dosage form combination, including:

patent expiration dates (non-extended),
any statutory exclusivity (if applicable to the listing),
pediatric exclusivity or other extensions tied to specific patents,
and whether exclusivity or patent coverage is claim-specific (e.g., method-of-use claims that do not block all generics).

Core investment implication: For a legacy anticoagulant, the primary “timer” is not exclusivity in the early years but the presence or absence of unexpired, enforceable patents that could delay generic approval or launch through litigation or settlement.

What is the Orange Book status of Angiomax RTU?

Orange Book status determines:

whether Angiomax RTU is listed with unexpired patents,
whether any patents are “listed” for the RTU product rather than for earlier/later variants,
and whether any patents are listed as method-of-use vs composition/formulation.

Core investment implication: If Orange Book lists are fully expired, investors should treat the asset as commercially defended primarily by contracting and procurement behavior, not by regulatory market power.

How many patents cover Angiomax RTU and what claim types matter?

To score defensibility, you need a count of listed patents by claim type:

composition of matter,
formulations,
manufacturing/process,
and method of use.

This count and distribution drive generic entry risk. A high share of method-of-use patents can create narrower entry barriers (a generic can still be launched if it carves out protected indications). A high share of composition/formulation patents increases the risk of full launch blocking.

Core investment implication: An investor’s base case typically assumes composition/formulation coverage has expired for older bivalirudin assets. If, however, RTU-specific patents remain unexpired and are composition/formulation-based, the risk/return profile improves materially.

Which companies are challenging Angiomax RTU with Paragraph IV certifications?

A Paragraph IV challenge analysis must be anchored to:

specific ANDA filings referencing the Angiomax RTU NDA,
certification types (I-IV),
filing dates,
and the resulting litigation docket outcomes or settlement terms.

Core investment implication: If there have been no Paragraph IV challenges (or if they were resolved without early generic entry), that supports a more stable pricing and share-retention model. If multiple Paragraph IV filings exist with unfavorable outcomes for the brand, the investment case shifts toward valuation with faster erosion.

What patent litigation affects Angiomax RTU and what were the outcomes?

Patent litigation analysis needs:

case numbers,
filing and decision dates,
asserted patents and claim charts,
preliminary injunction outcomes,
merits outcomes,
and any settlement agreements tied to launch dates or design-arounds.

Core investment implication: For an investment thesis, the key variable is not whether litigation occurred, but whether the brand extracted a delayed launch, secured an injunction, or induced a design-around that blunted generic impact.

What generic entry risks exist for Angiomax RTU?

Generic entry risk is governed by:

Orange Book “listed” unexpired patents,
whether challengers face injunction risk,
whether authorized generics appear,
and whether the generic route replicates manufacturing controls that affect regulatory interchangeability.

Core investment implication: If the patent estate is fully expired, entry risk becomes mostly pricing and contracting driven, not legal. The “entry” event then centers on when a low-cost supplier gains formulary access and displaces the brand.

How does Angiomax RTU compare with other anticoagulants on market substitution?

From an investment standpoint, substitution risk is often higher than legal entry risk for legacy anticoagulants. Key substitution axes include:

heparin-based strategies (with or without adjunct antiplatelet therapy depending on clinical context),
other IV anticoagulants where adopted by protocols,
and DOACs or other agents only where the indication and procedural context permit.

Core investment implication: Even without generic entry, Angiomax RTU can lose share if guidelines or provider preference shift toward alternatives.

What formulations are protected by Angiomax RTU patents?

Formulation protection matters if:

patents cover RTU-specific excipients, concentration, or stability/performance characteristics,
process patents constrain how the drug is manufactured or filled.

Core investment implication: If formulation and process patents are unexpired, they can delay generic approval or raise costs via compliance. If they are expired, regulatory pathway becomes easier and the economic outcome is more likely to be price compression.

What method-of-use patents apply to bivalirudin and Angiomax RTU?

Method-of-use coverage can matter if it is still active and ties to specific indications, procedure types, or dosing regimens. If method-of-use patents remain, generics can sometimes be approved with carve-outs, limiting market damage in only certain clinical scenarios.

Core investment implication: The investment base case should use indication-specific substitution rates rather than assuming full market interchangeability.

What FDA regulatory pathway supports Angiomax RTU and what does that mean for competitors?

For generics, the competitive entry path typically includes ANDA routes and bioequivalence requirements. For a sterile injectable, the practical barriers often include:

manufacturing controls,
sterility assurance,
and stability during distribution.

Core investment implication: If Angiomax RTU is considered hard-to-manufacture due to sterile filling processes, that can slow entry even after legal barriers expire.

What commercial metrics should investors track for Angiomax RTU?

Angiomax RTU’s business is procedure volume and contracting economics. Track:

U.S. quarterly net sales (brand and any competing labeled products),
inventory turns and supply continuity events,
wholesaler and hospital channel fill rates,
average selling price and net price vs list price,
formulary retention and conversion after competitive tendering.

Core investment implication: Investors should model not only “generic launch timing” but also “tender cycle timing,” because pricing erosion accelerates when suppliers win new multi-year agreements.

Revenue exposure: what drives Angiomax RTU demand?

Demand drivers for bivalirudin products typically include:

interventional cardiology volumes (PCI and related catheter-based procedures),
shifts in antithrombotic protocols,
hospital guideline committees and buy-and-use practices,
and relative cost-per-procedure compared with substitutes.

Core investment implication: The investment case is sensitive to utilization, not just pricing.

Which jurisdictions matter most for bivalirudin investment risk?

Most generic and IP risk is U.S.-centric for Angiomax RTU economics, but global manufacturing and supply chain outcomes can affect:

availability,
pricing power during shortages,
and cost of supply for the brand.

Core investment implication: Even if U.S. IP is weak, supply chain constraints can transiently protect margins. Conversely, strong generic activity abroad can spill into U.S. pricing via competition and distribution economics.

How strong is the patent estate for Angiomax RTU versus generic pressure?

A strength score requires:

the count of unexpired Orange Book patents,
the claim types and whether they block generic approval or can be carved out,
the litigation history and settlement-induced launch dates,
and whether there are remaining manufacturing/process constraints.

Core investment implication: For legacy bivalirudin, absent unexpired RTU-specific patents, “estate strength” is likely low and the asset behaves like a commoditizing brand under procurement-led margin compression.

Key takeaways

Angiomax RTU’s investment case is primarily commercial and procurement-driven rather than exclusivity-driven, unless RTU-specific Orange Book patents remain unexpired.
Patent defensibility depends on RTU-specific, claim-level Orange Book listings and any active litigation or settlement terms blocking launch.
Generic entry risk is best modeled as a combination of legal barriers (Orange Book/patents) and tender-driven adoption cycles (channel and hospital contracting).
Substitution by other anticoagulants and protocol changes can impact volume even without legal entry events.

FAQs

Does Angiomax RTU have Orange Book-listed patents still in force?
How do method-of-use patents for bivalirudin affect generic carve-outs?
What role do sterile injectable manufacturing and process controls play in generic entry for Angiomax RTU?
What indicators predict net price erosion for legacy injectables like Angiomax RTU after generic entry?
Which interventional cardiology protocol shifts most influence bivalirudin utilization?

References
(No sources were cited because the required Orange Book listing, NDA identifiers, patent numbers, and litigation dockets for Angiomax RTU were not provided in the prompt.)

ANGIOMAX RTU Drug Patent Profile

When do Angiomax Rtu patents expire, and when can generic versions of Angiomax Rtu launch?

DrugPatentWatch^® Litigation and Generic Entry Outlook for Angiomax Rtu

AI Deep Research

Questions you can ask:

Summary for ANGIOMAX RTU

US Patents and Regulatory Information for ANGIOMAX RTU