AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Amikin In Sodium Chloride 0.9% In Plastic Container, and when can generic versions of Amikin In Sodium Chloride 0.9% In Plastic Container launch?

Amikin In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is amikacin sulfate. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amikin In Sodium Chloride 0.9% In Plastic Container

A generic version of AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as amikacin sulfate by MEITHEAL on September 28^th, 1993.

Summary for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	2
DailyMed Link:	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Raja Isteri Pengiran Anak Saleha Hospital	N/A
Thammasat University	N/A

See all AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	050618-002	Nov 30, 1987		DISCN	No	No
Apothecon	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	050618-001	Nov 30, 1987		DISCN	No	No

AMIKIN in Sodium Chloride 0.9% Plastic Container: Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 9, 2026

AMIKIN in 0.9% sodium chloride plastic containers is a legacy amikacin sulfate intravenous product used primarily in hospital settings for serious gram-negative bacterial infections. Its commercial profile is defined by generic competition, limited outpatient use, antimicrobial stewardship, hospital purchasing pressure, and intermittent supply constraints. The product has no apparent remaining U.S. regulatory exclusivity, and its original compound and formulation protections have expired. Product-level revenue is not separately disclosed in public company filings, so the financial analysis must rely on the amikacin injectable market, hospital procurement behavior, and manufacturer economics.

What is AMIKIN in Sodium Chloride 0.9%?

AMIKIN is the branded name for amikacin sulfate, an aminoglycoside antibiotic. The product in a 0.9% sodium chloride plastic container is a ready-to-administer intravenous formulation, generally supplied in flexible containers at hospital-use concentrations such as 500 mg/100 mL or 1 g/200 mL, depending on the manufacturer and presentation.

Amikacin is indicated for serious infections caused by susceptible gram-negative organisms, including infections involving the respiratory tract, urinary tract, bloodstream, abdomen, skin, bone, and central nervous system. It is also used in selected multidrug-resistant infections when susceptibility testing supports treatment.[1]

The product has a narrow commercial role:

• It is administered primarily in hospitals and other institutional settings.
• It is usually selected for resistant gram-negative infections or when other aminoglycosides are unsuitable.
• It requires renal-function monitoring and, in some cases, serum drug-level monitoring.
• It has limited chronic-use potential because of nephrotoxicity and ototoxicity risks.
• Its demand is driven by hospital formularies, infection-control protocols, and local resistance patterns rather than consumer prescribing.

Product profile

Attribute	Product assessment
Active ingredient	Amikacin sulfate
Therapeutic class	Aminoglycoside antibacterial
Administration	Intravenous infusion; other amikacin presentations may support intramuscular use
Typical setting	Hospitals, intensive-care units, specialty infectious-disease care
Container	Flexible plastic intravenous container
Diluent	0.9% sodium chloride
Prescription status	Prescription-only hospital medicine
Regulatory pathway	Legacy branded product and generic injectable equivalents
Primary buyers	Hospitals, group purchasing organizations, distributors
Main competitors	Generic amikacin vials and premixed amikacin products; other aminoglycosides and newer anti-infectives

What is the FDA regulatory status of AMIKIN in Sodium Chloride?

AMIKIN is a legacy FDA-approved amikacin product, but the commercial status of the exact plastic-container presentation must be distinguished from the active ingredient’s broader approval history. FDA records may list individual presentations as approved, discontinued, or not currently marketed even when generic amikacin products remain available.

The original AMIKIN brand was approved decades ago. The active ingredient is now supplied mainly through generic injectable products and institutional premixes. FDA labeling identifies amikacin sulfate as an established treatment for serious bacterial infections, with dosing adjusted for body weight, renal function, and infection severity.[1]

A discontinued or inactive listing does not mean that amikacin has lost FDA approval as a molecule. It normally means that a particular sponsor, labeler, dosage form, or presentation is no longer actively marketed under that listing.

FDA status by commercial layer

Layer	Status
Amikacin active ingredient	Established FDA-approved antibacterial
Legacy AMIKIN brand	Mature product with limited current commercial relevance
Amikacin injection generics	Available from multiple manufacturers, subject to supply conditions
Ready-to-use sodium chloride premix	Marketed selectively; availability can vary by manufacturer and strength
New chemical entity exclusivity	Expired
Current branded price premium	Limited in institutional procurement

FDA Drugs@FDA and DailyMed should be used to distinguish the original AMIKIN approval from currently marketed generic or premixed products.[2][3]

When did AMIKIN lose exclusivity?

AMIKIN’s U.S. market exclusivity expired long ago. Amikacin is an established aminoglycoside introduced in the 1970s, and any original composition-of-matter protection is no longer commercially relevant. The product does not benefit from current new chemical entity exclusivity, orphan-drug exclusivity, pediatric exclusivity, or a comparable market-protection period.

The relevant competitive barriers are operational rather than patent-based:

• FDA approval of sterile injectable manufacturing sites
• Validation of aseptic filling and container-closure systems
• Drug-shortage conditions
• Hospital formulary access
• Distributor and group purchasing contracts
• Manufacturer reliability and inventory capacity

Exclusivity timeline

Event	Approximate timing	Commercial implication
Amikacin introduced	1970s	Original branded antibiotic launch
Original composition protection	Expired decades ago	No remaining compound-level barrier
Generic injectable competition	Established for many years	Price erosion and multi-source supply
Ready-to-use premixed products	Later formulation development	Convenience and medication-safety differentiation
Current market	Mature generic segment	Competition based on supply, price, and contracting

What patents protect AMIKIN in a 0.9% sodium chloride plastic container?

No active U.S. patent estate is apparent for the core amikacin molecule or the basic amikacin-in-normal-saline presentation. The product is not commercially protected by a modern compound patent.

Potentially relevant intellectual-property categories could include:

1. Container and delivery-system patents. These may cover flexible bags, ports, seals, overwraps, or manufacturing equipment, but such rights generally protect a container technology rather than amikacin itself.
2. Formulation patents. A patent could theoretically claim concentration, pH, stabilizers, or storage conditions. The standard amikacin-in-0.9% sodium chloride formulation has no apparent commercially significant active U.S. patent barrier.
3. Manufacturing patents. A supplier may protect aseptic filling, sterilization, or packaging processes. These rights do not normally prevent a competitor from producing amikacin using a different process.
4. Method-of-use patents. Historical amikacin treatment methods are generally too old to provide meaningful exclusivity. New use patents would need to claim a legally distinct and patentable indication or dosing method.

The practical conclusion is that patent risk to generic entry is low. The main barrier is regulatory execution for sterile products, not freedom to operate around AMIKIN’s active ingredient.

Orange Book position

The FDA Orange Book is relevant for identifying patents and exclusivity associated with approved drug products. For a legacy amikacin product, the expected position is:

Orange Book issue	Assessment
Active ingredient patent	None expected
Active formulation patent	None expected for the standard premix
Active method-of-use patent	None expected to constrain ordinary amikacin use
Pediatric exclusivity	Not expected
Orphan exclusivity	Not expected
Paragraph IV exposure	Low for the mature product; any challenge would target a specific listed patent
Generic substitution	Driven by state law, institutional contracts, and presentation compatibility

Because a ready-to-use premix may be approved under a separate application or generic pathway, an Orange Book search should be performed at the exact strength, dosage form, sponsor, and application number. Product-level Orange Book data can differ from the status of the active ingredient broadly.[4]

Are there Paragraph IV challenges or patent litigation involving AMIKIN?

There is no widely reported, commercially material Paragraph IV campaign directed at the standard AMIKIN-in-0.9% sodium chloride plastic-container product. That result is consistent with the product’s age and lack of an economically meaningful patent estate.

The absence of major litigation matters commercially. A generic applicant does not need to overcome a valuable branded patent position, and an incumbent has little basis for delaying entry through patent enforcement. Any dispute is more likely to concern:

• FDA approval status
• manufacturing-site compliance
• supply contracts
• product-quality allegations
• trademark or trade-dress issues
• shortages and allocation practices

Litigation outlook

Risk area	Current commercial significance
Patent infringement	Low
Paragraph IV litigation	Low
Biosimilar litigation	Not applicable
Product-liability litigation	Possible but not product-specific
Manufacturing compliance action	More relevant than patent litigation
Supply or contract disputes	Possible in shortage conditions
Trademark dispute	Limited, because generic amikacin is widely available

What formulations are protected by AMIKIN?

The standard plastic-container formulation has limited differentiation. Its value is primarily operational: it can reduce pharmacy compounding, improve dosing consistency, and reduce preparation time.

The relevant product attributes are:

• Amikacin sulfate concentration
• 0.9% sodium chloride vehicle
• Flexible plastic container
• Ready-to-administer or ready-to-dilute presentation
• Container volume and port configuration
• Storage period and handling requirements
• Compatibility with infusion systems
• Labeling and bar-code integration

These attributes may support product-specific regulatory filings or proprietary manufacturing processes, but they do not create a durable market monopoly. Hospitals can generally substitute generic vials, although substitution may impose pharmacy labor, preparation, waste, and medication-error costs.

Premix versus vial economics

Factor	Plastic-container premix	Conventional vial
Pharmacy preparation	Lower	Higher
Administration convenience	Higher	Requires dilution or preparation
Unit acquisition cost	Often higher	Often lower
Waste risk	Depends on fixed dose and patient size	Depends on vial size and dose
Medication-safety value	Potentially favorable	More preparation steps
Contracting leverage	Concentrated among fewer suppliers	Broader generic competition
Shortage substitution	May require vial conversion	Usually easier if vials are available

How strong is the patent estate for AMIKIN?

The patent estate is weak from an exclusivity perspective. The product has no apparent active composition-of-matter protection and no evident patent barrier that would materially prevent generic or alternative premix supply.

A practical strength assessment is:

Patent category	Strength	Reason
Compound patent	None	Amikacin is an old active ingredient
Core formulation patent	Low or none	Standard saline premix is readily reproducible
Delivery-container patent	Potentially narrow	May protect a supplier’s packaging platform
Method-of-use patent	Low	Conventional clinical uses are old
Manufacturing patent	Potentially moderate but non-blocking	Alternative processes can be developed
Overall exclusivity strength	Very low	Competition is primarily generic and operational

The product’s commercial defensibility is therefore based on supply reliability, customer contracts, quality history, and hospital workflow benefits rather than patents.

What is the market outlook for amikacin injection?

The amikacin injectable market is mature and structurally constrained. Volume is supported by antimicrobial resistance, but use is limited by toxicity, stewardship controls, and competition from newer agents.

Demand drivers

• Increasing prevalence of multidrug-resistant gram-negative infections
• Use in intensive-care and transplant settings
• Treatment of selected carbapenem-resistant organisms
• Use when susceptibility data support aminoglycoside therapy
• Hospital demand for ready-to-use products that reduce compounding
• Periodic shortages of competing injectable antibiotics

Demand constraints

• Nephrotoxicity and ototoxicity
• Renal-dose adjustment requirements
• Therapeutic drug monitoring in selected patients
• Restricted use under antimicrobial-stewardship programs
• Competition from ceftazidime-avibactam, meropenem-vaborbactam, cefiderocol, polymyxins, and other agents
• Reduced use when less toxic therapies are clinically appropriate

The net market profile is low-to-moderate volume with episodic demand spikes. Resistance supports a strategic reserve role, but stewardship limits routine utilization.

What is the financial trajectory for AMIKIN?

Public filings generally do not report AMIKIN in sodium chloride separately. The product is too small and mature to appear as an individually disclosed revenue line for most manufacturers. The financial trajectory must therefore be assessed through category economics.

Revenue trajectory

Period	Expected trajectory	Primary explanation
Original branded period	High product-level value	Limited competition and branded pricing
Early generic period	Sharp decline	Multi-source competition and price erosion
Mature generic period	Low, stable base	Institutional use remains clinically necessary
Shortage periods	Temporary price and volume uplift	Allocation, emergency purchasing, and substitution
Long term	Flat to declining underlying revenue	Stewardship, generic competition, and alternative antibiotics

The premix presentation may command a higher price per dose than a vial because it reduces preparation work. That price advantage does not necessarily translate into high margins. Sterile manufacturing, plastic-container production, quality control, freight, and inventory requirements reduce contribution margins.

Manufacturer economics

Profitability depends on five variables:

1. Manufacturing utilization. Low-volume sterile lines have high fixed costs.
2. Contracting structure. Group purchasing organizations can compress net prices.
3. Shortage exposure. Supply disruptions can raise realized prices but also increase regulatory and operational risk.
4. Container cost. Flexible bags, ports, overwraps, and packaging contribute materially to cost of goods.
5. Product mix. Higher concentrations and larger institutional orders can improve production efficiency.

The most attractive commercial position belongs to suppliers with established sterile injectable capacity, strong hospital distribution, and the ability to maintain supply during shortages.

Which companies compete with AMIKIN?

Competition exists at two levels: direct product competition and therapeutic substitution.

Direct product competitors

Direct competitors include generic manufacturers and hospital-supply companies offering:

• Amikacin sulfate injection in vials
• Amikacin sulfate in 0.9% sodium chloride premix bags
• Alternative ready-to-administer injectable presentations

Relevant manufacturers in the broader generic injectable market have included companies such as Pfizer, Fresenius Kabi, Hikma, Sandoz, and other FDA-approved suppliers, although product availability varies by strength, facility, and time period. A specific manufacturer’s current marketing status must be confirmed through FDA listings and current National Drug Codes.[2][5]

Therapeutic competitors

Competitor class	Commercial effect
Gentamicin and tobramycin	Substitute aminoglycosides for selected susceptible organisms
Polymyxins	Alternative for resistant gram-negative infections, with substantial toxicity limitations
New beta-lactam/beta-lactamase inhibitors	Reduce amikacin use where susceptibility and reimbursement permit
Cefiderocol	Competes in selected multidrug-resistant infections
Carbapenems	Compete when organisms remain susceptible
Non-antibiotic supportive care	Does not replace therapy but affects hospitalization and treatment duration

Amikacin retains value when resistance patterns limit safer alternatives or when an institution needs a low-cost reserve antibiotic.

What generic launch scenarios exist for AMIKIN?

Because core exclusivity has expired, a new entrant would not need to wait for patent expiration. Its launch decision would depend on regulatory and commercial economics.

Scenario 1: Additional vial entrant

This is the lowest-complexity route. A manufacturer introduces standard amikacin injection in vials. The market is competitive, and price pressure is severe.

Commercial result: modest volume opportunity, low price, limited differentiation.

Scenario 2: Ready-to-use premix entrant

A new supplier launches the drug in sodium chloride plastic containers.

Commercial result: higher hospital convenience value, but greater manufacturing complexity and stronger competition for institutional contracts.

Scenario 3: Shortage-driven entry

A supplier enters or expands production when existing manufacturers experience shortages.

Commercial result: rapid demand capture is possible, but the opportunity may decline once supply normalizes.

Scenario 4: Contract-focused entry

A supplier targets hospital systems, group purchasing organizations, or government accounts with guaranteed supply and standardized presentations.

Commercial result: more predictable volume, but lower net pricing and significant service obligations.

Does AMIKIN have biosimilar risk?

No. Biosimilar risk is not applicable because amikacin is a chemically synthesized small-molecule drug, not a biologic. The relevant competitive threat is generic substitution and therapeutic substitution.

The product faces greater generic risk than biosimilar risk because:

• The active ingredient is old and well characterized.
• Injectable formulations are established.
• Clinical use does not depend on a proprietary biologic manufacturing platform.
• FDA approval can be pursued through an abbreviated pathway when requirements are met.
• Hospital purchasers generally prioritize price and supply reliability.

What licensing deals affect AMIKIN?

No major current licensing transaction is publicly associated with AMIKIN in a sodium chloride plastic container. The legacy brand’s commercial history involved originator-company ownership and distribution, but current market economics are driven by generic manufacturing, contract supply, and distribution agreements.

Relevant transaction structures are more likely to include:

• Contract manufacturing agreements
• Private-label hospital supply arrangements
• Group purchasing organization contracts
• Regional distribution agreements
• Portfolio acquisitions involving generic injectable products
• Technology licenses for flexible-container platforms

These arrangements may affect availability and margin without creating product-level patent exclusivity.

What geographic coverage does the product have?

The product’s strongest commercial relevance is in the United States hospital market, where FDA-approved injectable products are purchased through distributors and group purchasing organizations. Comparable amikacin products are also marketed internationally, but regulatory status, container formats, concentrations, and brand ownership differ by country.

Geography	Market characteristics
United States	FDA-regulated, GPO-driven, multi-source generic market
European Union	National procurement, hospital tenders, differing product labels
Emerging markets	Greater reliance on generic vials; premix penetration varies
Low- and middle-income markets	Price-sensitive; ready-to-use plastic-container adoption is more limited
Japan and selected Asian markets	Local regulatory and procurement structures; resistance patterns influence use

The U.S. market is more favorable for premix products than markets where labor costs are lower or hospitals rely heavily on vial-based compounding.

What manufacturing and IP barriers affect the product?

Manufacturing is the principal barrier to entry. A supplier must demonstrate control over:

• Sterile compounding and aseptic filling
• Container-closure integrity
• Particulate and endotoxin control
• Stability throughout the labeled shelf life
• Extractables and leachables from plastic materials
• Shipping and temperature robustness
• Labeling, bar coding, and infusion compatibility
• FDA inspection and quality-system compliance

These requirements can delay entry and make a nominally unprotected product economically unattractive. Manufacturing failures can also produce shortages, recalls, or loss of hospital contracts.

The IP barrier is much lower. Container technology and production processes may be protected in narrow ways, but a competitor can generally design around those rights.

Key Takeaways

• AMIKIN in 0.9% sodium chloride plastic containers is a mature hospital injectable product with limited branded commercial value.
• Amikacin’s original compound and conventional-use protections expired decades ago.
• No meaningful active patent estate or current exclusivity barrier is apparent for the standard premix.
• Paragraph IV and patent-litigation risk are low; manufacturing and supply risks are more important.
• Revenue is not publicly reported at the individual product level.
• Underlying revenue is likely low and stable to declining, with temporary increases during shortages.
• Premixed bags can command workflow-based pricing over vials, but sterile manufacturing and GPO contracting constrain margins.
• Antimicrobial resistance supports reserve demand, while toxicity and stewardship restrict routine use.
• Biosimilar competition is irrelevant; generic and therapeutic substitution are the principal threats.
• The strongest competitive advantage is reliable FDA-compliant supply, not intellectual property.

FAQs About AMIKIN in Sodium Chloride Plastic Containers

Is AMIKIN in sodium chloride still commercially important?

It has limited branded importance but remains clinically relevant as a reserve injectable antibiotic for serious and resistant gram-negative infections.

Can hospitals substitute an amikacin vial for the premixed plastic-container product?

Often yes, but substitution may require pharmacy preparation, dose verification, compatibility review, and additional labor. Institutional policies and product availability control the practical result.

Is AMIKIN protected by an active U.S. patent?

The core amikacin molecule and standard saline formulation do not appear to have an active commercially meaningful U.S. patent barrier.

Could a generic manufacturer launch a competing amikacin premix?

Yes. The principal hurdles are FDA approval, sterile manufacturing capacity, stability data, container compatibility, and hospital contracting rather than patent clearance.

What would most improve the product’s financial outlook?

A sustained injectable-antibiotic shortage, a hospital contract tied to guaranteed supply, or a differentiated ready-to-administer presentation could improve revenue. Without those factors, the product remains a low-growth generic injectable.

References

1. U.S. Food and Drug Administration. (n.d.). Amikacin sulfate injection prescribing information. FDA. https://www.accessdata.fda.gov
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. National Library of Medicine. (n.d.). DailyMed: Amikacin sulfate injection labels. DailyMed. https://dailymed.nlm.nih.gov/dailymed/
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
5. U.S. Food and Drug Administration. (n.d.). National Drug Code directory. FDA. https://www.accessdata.fda.gov/scripts/cder/ndc/