When will the patents on AMIKIN expire, and when will AMIKIN 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
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062311-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apothecon	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	050618-002	Nov 30, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062311-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ 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: August 7, 2026

AMIKIN is the legacy brand of amikacin sulfate, an injectable aminoglycoside antibiotic used primarily for serious gram-negative infections and selected resistant mycobacterial infections. Its commercial trajectory is defined by mature genericization, limited brand differentiation, low regulatory exclusivity, and periodic hospital-supply volatility. The original innovator opportunity has largely expired; current value sits in sterile manufacturing capacity, dependable supply, contracting, and specialized infectious-disease demand.

What is AMIKIN and how is it used?

AMIKIN contains amikacin sulfate, a semisynthetic aminoglycoside administered by intravenous or intramuscular injection. It is used when bacterial susceptibility supports aminoglycoside treatment, particularly in severe infections caused by aerobic gram-negative organisms. The FDA label identifies use in septicemia, respiratory tract infections, bone and joint infections, central nervous system infections, intra-abdominal infections, burns, and complicated urinary tract infections, subject to susceptibility and clinical judgment (FDA, 2023).

Amikacin also has an important role in treatment of nontuberculous mycobacterial disease. Liposomal inhaled amikacin, marketed as ARIKAYCE, is a separate product with a different formulation, delivery system, regulatory history, and patent estate. ARIKAYCE should not be treated as a patent or revenue extension of AMIKIN.

Attribute	AMIKIN / amikacin injection
Active ingredient	Amikacin sulfate
Drug class	Aminoglycoside antibacterial
Route	Intravenous or intramuscular
Primary setting	Hospital and acute-care treatment
Regulatory category	Small-molecule prescription drug
Innovator	Historically Bristol-Myers Squibb
Current market structure	Multiple generic manufacturers
Biosimilar exposure	None
Primary commercial risk	Generic price competition and sterile-supply disruption

What is the FDA regulatory status of AMIKIN?

The original AMIKIN product was approved through an FDA new drug application associated with amikacin sulfate injection. Current U.S. treatment is supplied predominantly through generic amikacin sulfate injection products rather than a high-value branded AMIKIN franchise.

Amikacin sulfate injection is an established FDA-approved product. Generic versions are approved through abbreviated new drug applications, allowing applicants to rely on the reference product’s safety and efficacy findings while demonstrating pharmaceutical equivalence and bioequivalence where applicable.

The FDA label includes boxed-warning-level concerns relating to nephrotoxicity, ototoxicity, and neuromuscular blockade. These risks support hospital monitoring but do not create commercial exclusivity. They can increase switching friction between suppliers when hospitals qualify injectable products, but they do not protect a particular manufacturer from generic competition.

Is AMIKIN still marketed as a branded product?

AMIKIN has little evidence of a commercially meaningful standalone branded franchise in the U.S. The market is supplied principally through generic amikacin sulfate injection products. Product availability may vary by presentation, concentration, vial or premixed format, and manufacturer.

“AMIKIN” therefore has greater historical and clinical-recognition value than current brand economics. Revenue attributable specifically to the legacy brand is not separately disclosed in Bristol-Myers Squibb public financial reporting.

What patents protect AMIKIN and amikacin injection?

The original composition and product patents associated with amikacin injection expired many years ago. Amikacin is a mature small molecule with no commercially meaningful U.S. composition-of-matter exclusivity remaining.

Protection category	Current commercial significance
Amikacin composition patent	Expired
Original injectable formulation protection	Expired or no longer commercially material
Original AMIKIN regulatory exclusivity	Expired
Generic ANDA pathway	Available
Current AMIKIN blocking patent	No material blocking estate identified
ARIKAYCE patents	Separate product and should not be attributed to AMIKIN

The absence of a meaningful patent estate does not eliminate all intellectual-property issues. Manufacturers may hold process patents, container-closure patents, manufacturing know-how, or patents covering specialized delivery systems. Those rights generally do not prevent ordinary generic amikacin injection competition.

Does AMIKIN have Orange Book-listed patents?

The relevant commercial conclusion is that ordinary amikacin sulfate injection does not have a significant active Orange Book patent barrier comparable with recently launched branded drugs. Generic manufacturers can compete through the ANDA route, subject to FDA approval, manufacturing compliance, and product-specific requirements.

An Orange Book review should distinguish:

The historical AMIKIN reference product.
Generic amikacin sulfate injection products.
ARIKAYCE, which has separate listed patents and exclusivity.
Other inhaled, liposomal, or combination amikacin products.

Confusing AMIKIN with ARIKAYCE can materially overstate the patent strength and financial value of the injectable product.

When did AMIKIN lose exclusivity?

AMIKIN lost meaningful U.S. market exclusivity decades ago. The product is well beyond the five-year new chemical entity exclusivity period and any original orphan or pediatric exclusivity that might have applied to a particular indication or labeling event.

No current regulatory exclusivity is expected to prevent ANDA competition for conventional amikacin sulfate injection. The product’s commercial life is therefore governed by generic competition, hospital tenders, supply continuity, and manufacturing economics rather than by patent expiration timing.

What is the AMIKIN patent expiration timeline?

Milestone	Commercial effect
Original AMIKIN approval	Established the innovator product
Original composition and product protection	Expired decades ago
Generic entry	Converted the market to multisource supply
Current period	No meaningful patent-driven launch date
Future market	Continued generic supply, with possible shortage-driven price movements

A precise original patent-by-patent expiration schedule has limited decision value because the relevant exclusivity has already ended and generic entry is established.

Are there Paragraph IV challenges to AMIKIN?

Paragraph IV litigation is not a material current feature of the conventional amikacin injection market. Paragraph IV certifications are most important when an ANDA applicant challenges an active Orange Book patent. Amikacin injection is a mature generic product with no widely recognized blocking patent dispute that would delay ordinary market access.

Competition can still be delayed by FDA review, manufacturing observations, product-specific deficiencies, supply interruptions, or contract qualification requirements. Those barriers are operational rather than patent-based.

What patent litigation affects AMIKIN?

No major active U.S. patent litigation is central to the conventional AMIKIN or generic amikacin injection market. Litigation risk is more relevant to newer amikacin delivery systems, especially inhaled products, than to the legacy injectable formulation.

What formulations are protected in the amikacin market?

The basic injectable formulation is commercially commoditized. Differentiation is more likely to arise from presentation and delivery than from the active ingredient.

Conventional injectable amikacin

Generic products are available in multiple strengths and container formats. Important commercial variables include:

Concentration and vial size.
Ready-to-use versus pharmacy-compounded presentation.
Preservative content.
Single-dose versus multidose packaging.
IV compatibility and administration requirements.
Storage conditions and shelf life.
Availability in hospital-specific procurement systems.

These attributes can support supplier preference, but they generally do not create durable patent exclusivity.

Liposomal inhaled amikacin

ARIKAYCE uses a liposomal inhalation system and is commercially distinct from AMIKIN. Its value is based on pulmonary delivery, regulatory approvals, clinical positioning, and a separate patent and exclusivity framework. It should be analyzed as a separate asset.

How strong is the AMIKIN patent estate?

The patent estate for conventional AMIKIN is weak from an exclusivity perspective.

Patent-strength factor	Assessment
Composition-of-matter protection	None of current commercial significance
Formulation protection	Limited for standard injection
Method-of-use protection	Limited ability to block generic use
Delivery-system protection	Relevant only to specialized products
Manufacturing know-how	Potentially important operationally
Litigation leverage	Low
Generic substitution risk	High

The strongest defensible assets in the mature injectable market are not patents. They are validated sterile facilities, regulatory history, reliable API procurement, hospital contracts, and the ability to maintain supply during shortages.

How does the AMIKIN market make money?

Amikacin injection is a low-price, hospital-oriented generic market. Revenue is generated through volume, tenders, wholesaler contracts, group purchasing organizations, and supply reliability rather than premium brand pricing.

Revenue exposure

Bristol-Myers Squibb does not report AMIKIN as a separate revenue line. The legacy brand is unlikely to represent material exposure in the company’s current consolidated revenue base. Generic manufacturers also generally report amikacin within broader hospital injectable or generic portfolios rather than as a separately disclosed franchise.

The financial profile has three layers:

Innovator value: Minimal direct revenue contribution after genericization.
Generic manufacturer value: Low unit economics but recurring institutional demand.
Specialized delivery value: Higher potential pricing for differentiated products such as liposomal inhaled amikacin.

Margin drivers

Margins depend on:

Amikacin sulfate API costs.
Sterile filling and packaging costs.
Batch yields and quality-control requirements.
Contract pricing.
Number of qualified competitors.
FDA compliance costs.
Hospital shortage conditions.
Product presentations and container availability.

Sterile injectables can have better supply discipline than oral generics because manufacturing is technically demanding. That does not guarantee high margins. Hospitals and group purchasing organizations typically exert significant pricing pressure.

What are the main market dynamics for amikacin?

Hospital demand remains clinically durable

Amikacin remains relevant when resistance patterns limit use of other antibiotics. Demand is tied to intensive care, complicated infections, transplant medicine, oncology, and resistant gram-negative disease. Use is constrained by nephrotoxicity and ototoxicity, which encourage therapeutic drug monitoring and stewardship.

Generic competition limits pricing power

The market has multiple generic suppliers and a mature clinical profile. Hospitals can substitute among equivalent products after formulary and quality qualification. This suppresses long-term price expansion.

Shortages can create temporary pricing spikes

Injectable antibiotic markets are vulnerable to shortages caused by API constraints, plant shutdowns, quality remediation, and limited manufacturing redundancy. A shortage can increase order volume and improve pricing for suppliers with available inventory. These gains are usually temporary and can reverse when competing supply returns.

Antimicrobial stewardship limits volume expansion

Stewardship programs seek to restrict broad-spectrum antibiotic use and reduce unnecessary aminoglycoside exposure. This limits volume growth even when resistance supports continuing clinical demand.

Diagnostic testing affects utilization

More rapid susceptibility testing can improve targeted amikacin use in resistant infections. It can also reduce empiric use by allowing clinicians to select narrower or less toxic therapies. The net effect is better targeting rather than broad volume expansion.

What generic entry risks exist for AMIKIN?

Generic entry is already established, so the principal risk is not a future first generic launch. The key risks are further supplier entry, price erosion, contract displacement, and hospital substitution.

Risk	Likely effect
New generic entrant	Lower prices and reduced incumbent share
Supplier consolidation	Higher shortage risk if capacity falls
API disruption	Temporary volume loss or price increase
FDA manufacturing action	Product withdrawal or supply interruption
Hospital tender loss	Rapid account-level revenue decline
Stewardship restriction	Lower utilization
Competing antibiotics	Reduced clinical demand
Specialized delivery products	Segmentation of selected indications

What licensing deals affect AMIKIN?

No major contemporary licensing transaction is central to the conventional AMIKIN injectable market. The original brand was associated with the innovator’s historical commercialization rights, but the product’s patent expiry and generic competition have removed most licensing value.

Licensing activity is more relevant to:

Liposomal amikacin delivery systems.
Inhaled antibiotic platforms.
Combination therapies.
Regional distribution rights.
Contract manufacturing and sterile-fill capacity.

These arrangements should not be interpreted as evidence of renewed exclusivity for AMIKIN injection.

How does AMIKIN compare with ARIKAYCE?

Factor	AMIKIN / amikacin injection	ARIKAYCE
Delivery	IV or IM	Inhaled liposomal suspension
Market	Mature generic hospital product	Specialized branded therapy
Patent strength	Weak or expired	Material product-specific estate
Regulatory exclusivity	Expired	Product-specific exclusivity history
Pricing	Generic and tender-driven	Specialty branded pricing
Main indication profile	Serious bacterial infections	Selected refractory pulmonary mycobacterial disease
Biosimilar risk	None	None as a biologic, but product-specific competition is relevant
Commercial thesis	Supply and cost efficiency	Clinical differentiation and protected delivery

The comparison shows why amikacin-related revenue estimates must separate injectable AMIKIN from ARIKAYCE.

What is the likely financial trajectory for AMIKIN?

The conventional injectable product has a mature-to-declining nominal revenue profile, with intermittent increases caused by shortages, tenders, or supplier exits. Long-term market growth is unlikely to come from price expansion.

Base case

Volume remains stable in hospitals treating resistant infections. Generic pricing remains competitive. Revenue is broadly flat to declining, with individual manufacturers gaining or losing share through contracts and supply performance.

Upside case

A shortage, API disruption, or competitor manufacturing failure increases demand for suppliers with available FDA-compliant inventory. Revenue and margins improve temporarily. The benefit fades as supply normalizes.

Downside case

Additional generic entry, lower hospital utilization, stewardship restrictions, or substitution by newer antibiotics reduces volume and price. Suppliers with high fixed sterile-manufacturing costs face margin compression.

Investor interpretation

AMIKIN is not a conventional growth pharmaceutical asset. Its value is defensive and operational. Attractive exposure depends on manufacturing efficiency, shortage positioning, institutional contracts, and portfolio synergies with other sterile anti-infectives. A standalone branded valuation based on patent protection or premium pricing would be unsupported.

What is the competitive landscape for amikacin?

Competition includes generic sterile-injectable manufacturers supplying hospitals and wholesalers. The relevant competitive set is determined by FDA-approved presentations, national distribution, shortage status, and group purchasing contracts rather than by consumer brand awareness.

Competitors may include large generic manufacturers, hospital-focused injectable suppliers, and regional pharmaceutical companies. Market share can change quickly when one supplier loses manufacturing capacity or receives a warning letter.

The principal competitive barriers are:

FDA-compliant sterile manufacturing.
Reliable amikacin sulfate API sourcing.
Validated analytical methods.
Capacity for multiple vial sizes.
Distribution through hospital channels.
Ability to satisfy procurement and shortage requirements.

Key Takeaways

AMIKIN is the legacy brand of amikacin sulfate injection.
Conventional injectable amikacin is a mature generic market with no meaningful current patent barrier.
Original AMIKIN exclusivity expired decades ago.
Paragraph IV litigation and active patent disputes are not major current market drivers.
Bristol-Myers Squibb does not disclose standalone AMIKIN revenue.
Financial performance is driven by hospital contracts, generic pricing, sterile capacity, and supply continuity.
Shortages can produce temporary revenue and margin increases.
Antimicrobial stewardship and toxicity concerns limit structural volume growth.
ARIKAYCE is a separate liposomal inhaled product with a different commercial and patent profile.
The strongest current barriers are manufacturing and regulatory execution, not patents.

FAQs about AMIKIN market exclusivity and commercial risk

Is AMIKIN a biologic drug?

No. AMIKIN contains amikacin sulfate, a small-molecule aminoglycoside antibiotic. Biosimilar regulation does not apply. Competition occurs through generic drug pathways.

Can a generic manufacturer launch amikacin injection without a patent challenge?

Yes. Because conventional amikacin injection has no material active patent barrier, an ANDA applicant generally does not need to overcome a commercially significant blocking patent to enter the market.

Does AMIKIN have pediatric exclusivity?

Any original pediatric exclusivity associated with historical labeling would have expired. It does not create a current barrier to generic amikacin injection.

Is amikacin injection a shortage-sensitive product?

Yes. Sterile injectable antibiotics can experience supply interruptions because of API constraints, manufacturing deviations, quality remediation, and limited redundant capacity. Shortage exposure is a key commercial variable.

Is ARIKAYCE a replacement for AMIKIN?

No. ARIKAYCE is an inhaled liposomal formulation designed for a distinct pulmonary indication and patient population. It should be assessed separately from conventional intravenous or intramuscular amikacin.

References

U.S. Food and Drug Administration. (2023). Amikacin sulfate injection prescribing information. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
National Library of Medicine. (2024). Amikacin sulfate injection: DailyMed labeling. DailyMed.
U.S. Food and Drug Administration. (2023). ARIKAYCE prescribing information. FDA.
Bristol-Myers Squibb Company. (2024). Annual report. U.S. Securities and Exchange Commission.

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
DailyMed Link:	AMIKIN at DailyMed

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