When do the patents on AKOVAZ expire, and when will generic AKOVAZ be available?

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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
Exela Pharma	AKOVAZ	ephedrine sulfate	SOLUTION;INTRAVENOUS	208289-002	Aug 2, 2021	AP3	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Exela Pharma	AKOVAZ	ephedrine sulfate	SOLUTION;INTRAVENOUS	208289-001	Apr 29, 2016	AP	RX	Yes	Yes	⤷ 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: September 2, 2026

AKOVAZ is Akorn’s branded version of ephedrine sulfate injection, a generic hospital product used primarily to treat clinically significant hypotension occurring during anesthesia. Its commercial profile is driven by hospital purchasing contracts, supply reliability, FDA shortage conditions, and Akorn’s 2023 bankruptcy rather than by patent exclusivity. Product-level revenue has not been separately disclosed, so AKOVAZ’s direct financial trajectory cannot be isolated from Akorn’s broader injectable portfolio.

What is AKOVAZ and how is it used?

AKOVAZ contains ephedrine sulfate, a sympathomimetic amine used to increase blood pressure in the perioperative setting. The product is administered intravenously or intramuscularly by healthcare professionals.

Attribute	AKOVAZ profile
Active ingredient	Ephedrine sulfate
Dosage form	Injection
Strength	50 mg/mL
Primary setting	Operating rooms, anesthesia, hospital care
Regulatory pathway	FDA-approved prescription drug
Product type	Generic injectable
Original manufacturer	Akorn, Inc.
Primary demand driver	Procedure volume and hospital supply requirements
Patent dependence	Low; commercial access is mainly regulatory and operational

The FDA-approved labeling identifies AKOVAZ as an ephedrine sulfate injection for the treatment of clinically important hypotension in the setting of anesthesia. The product is not a novel-molecule medicine and does not have the pricing power associated with a patented branded therapy. (U.S. Food and Drug Administration [FDA], 2016)

What is the FDA regulatory status of AKOVAZ?

AKOVAZ was approved under FDA New Drug Application 208289. Although the product is a generic therapeutic equivalent in commercial positioning, ephedrine sulfate injection products may be approved under different regulatory pathways depending on formulation, reference-product history, and manufacturing site.

The FDA label identifies the product as an injection containing ephedrine sulfate, sodium chloride, and water for injection. The product is supplied for institutional use and is not a retail pharmacy-driven medicine.

Key FDA characteristics

FDA-approved indication: clinically significant hypotension during anesthesia.
Dosage form: sterile injectable solution.
Administration: intravenous or intramuscular use.
Clinical buyers: hospitals, ambulatory surgery centers, anesthesia groups, and group purchasing organizations.
Prescribing environment: institutional protocols and perioperative formularies.

The product’s economic value depends heavily on its availability. Injectable hospital medicines are vulnerable to manufacturing interruptions because they require sterile production, validated filling operations, quality-control testing, and reliable component supply.

When does AKOVAZ lose exclusivity?

AKOVAZ does not appear to have a material patent-exclusivity profile comparable with innovative pharmaceutical products. Ephedrine sulfate is an established active ingredient, and the commercial barriers are primarily FDA approval, sterile manufacturing capability, customer contracts, and supply continuity.

No major AKOVAZ composition-of-matter patent, formulation patent, or method-of-use patent is generally associated with the product’s market position. The relevant exclusivity analysis is therefore:

Exclusivity category	AKOVAZ position
New chemical entity exclusivity	Not applicable
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No material product-specific protection identified
Composition-of-matter patent	No material protection identified
Formulation patent	No material protection identified
Method-of-use patent	No material protection identified
Regulatory market exclusivity	Limited or absent as a mature ephedrine product
Manufacturing barrier	High relative to the product’s low unit price

The absence of meaningful patent protection leaves AKOVAZ exposed to competing ephedrine sulfate injections. However, generic competition does not automatically produce rapid entry because sterile injectable manufacturing capacity is limited and hospital buyers prioritize dependable supply.

How many patents cover AKOVAZ?

AKOVAZ’s commercial patent estate is effectively immaterial. The product’s active ingredient, ephedrine sulfate, is long established, and any historical intellectual-property rights would not be expected to block modern generic competition.

The relevant protection is operational rather than patent-based:

FDA approval for the specific product and manufacturing process.
Compliance with current good manufacturing practices.
Validated sterile filling and packaging capacity.
Hospital and group purchasing contracts.
Qualified supplier status.
Reliable distribution through pharmaceutical wholesalers.

This structure creates a low patent barrier but a potentially significant manufacturing barrier. A competitor can theoretically enter without resolving a patent dispute, but it still needs an approved application, suitable production capacity, and sufficient commercial scale.

What caused AKOVAZ’s market disruption?

The principal market disruption was Akorn’s financial collapse. Akorn filed for Chapter 11 bankruptcy protection in 2023 after extended financial, operational, and litigation problems. The company later moved toward liquidation and asset disposition rather than a conventional recovery of its branded and generic pharmaceutical business. (Akorn Operating Company LLC, 2023; United States Bankruptcy Court, 2023)

For AKOVAZ, the consequences included:

Risk of manufacturing interruption.
Reduced confidence among hospital purchasers.
Potential loss of contracted supply positions.
Greater reliance on alternative ephedrine sulfate suppliers.
Pressure on the FDA shortage system.
Weaker investment in product maintenance and commercial support.

The product’s market value was therefore damaged less by clinical substitution than by uncertainty over supply continuity and manufacturer viability.

Was AKOVAZ listed in the FDA drug-shortage system?

Ephedrine sulfate injection has experienced supply constraints in the U.S. market. FDA shortage conditions for injectable ephedrine products have been linked to manufacturing delays, increased demand, raw-material constraints, and broader sterile injectable capacity problems.

Shortage status can differ by manufacturer, presentation, and available inventory. A shortage affecting ephedrine sulfate injection does not necessarily mean that every AKOVAZ package size is unavailable. It can, however, increase substitution activity and allow remaining suppliers to improve utilization and negotiating leverage.

The FDA Drug Shortages database is the controlling source for current product-level availability. (FDA, n.d.-a)

Why shortage conditions matter financially

A shortage can produce two opposing effects:

It can increase the value of an available product by making hospitals more willing to accept alternate suppliers or higher prices.
It can reduce the value of a product associated with a financially distressed manufacturer because buyers may avoid future supply risk.

For AKOVAZ, the second effect became more important after Akorn’s bankruptcy. Hospitals generally prefer a product with a stable manufacturer, even when the active ingredient is identical.

Which companies compete with AKOVAZ?

AKOVAZ competes with other ephedrine sulfate injection suppliers rather than with branded drugs in the conventional pharmaceutical sense. The competitive field includes manufacturers with FDA-approved ephedrine sulfate injections, contract manufacturers, and distributors supplying hospital systems.

Potential competitive products have included ephedrine sulfate injections from companies such as Pfizer and other injectable-drug manufacturers, depending on product availability and FDA listing status. Competition can change quickly because sterile injectable products enter and leave the market in response to manufacturing economics.

Competitive factor	Effect on AKOVAZ
Number of approved suppliers	More suppliers increase price pressure
Manufacturing interruptions	Improve the value of available inventory
GPO contracts	Can lock in volume and reduce spot-market flexibility
Hospital formulary status	Determines routine use
Product presentation	Vials, ampules, and concentration affect substitution
Shortage severity	Can shift demand rapidly between suppliers
Manufacturer credit quality	Affects procurement decisions

The product is not meaningfully differentiated on pharmacology. Differentiation depends on packaging, availability, quality history, delivery performance, and contract terms.

How strong is the AKOVAZ patent estate?

AKOVAZ has a weak patent estate but may have had temporary commercial protection through execution.

Patent strength

Composition-of-matter protection: negligible.
Active-ingredient differentiation: negligible.
Formulation protection: limited.
Method-of-use protection: limited.
Regulatory approval barrier: moderate.
Sterile manufacturing barrier: meaningful.
Distribution and contracting barrier: meaningful.
Long-term pricing power: weak.

This is a typical profile for a mature injectable generic. The absence of patents does not make entry frictionless, but it prevents the owner from using patent litigation to delay competitors.

Are there Paragraph IV challenges involving AKOVAZ?

No major Paragraph IV litigation is generally associated with AKOVAZ. Paragraph IV disputes are more relevant when a generic applicant challenges listed patents for a branded reference product. AKOVAZ itself is a mature ephedrine sulfate product with no widely recognized patent barrier requiring a Paragraph IV strategy.

The relevant competitive risks are instead:

New ANDA or abbreviated regulatory entries.
Product discontinuation.
FDA manufacturing findings.
Supplier insolvency.
Hospital contract losses.
Competing products benefiting from shortage allocation.
Substitution by other vasopressors where clinically appropriate.

The lack of Paragraph IV activity lowers litigation exposure but also means the product has little legal protection against direct generic competition.

What is the financial trajectory of AKOVAZ?

AKOVAZ’s standalone revenue, gross margin, prescription volume, and operating income have not been publicly reported. Akorn reported financial results at the company or segment level and did not provide a separate AKOVAZ revenue line.

The defensible financial trajectory is therefore qualitative:

Period	Financial and market position
Initial commercialization	Entry into the institutional injectable market with limited patent protection
Mature operating period	Recurring hospital demand, low-to-moderate pricing power, and dependence on manufacturing reliability
Pre-bankruptcy period	Greater operational and financial pressure within Akorn
2023 bankruptcy	Material increase in supply and counterparty risk
Post-bankruptcy transition	Uncertain continuity, possible ownership or manufacturing changes, and reduced brand value
Long-term outlook	Commodity-like economics unless shortage conditions or a stable new owner support continued supply

AKOVAZ likely generated recurring but relatively concentrated institutional revenue. Its economics would have depended on volume, production yield, manufacturing utilization, and hospital contracts rather than premium pricing.

The product’s revenue exposure was probably modest relative to Akorn’s full portfolio, but a low-revenue injectable can still have strategic value when it occupies manufacturing capacity, supports hospital contracts, or fills a shortage-sensitive category.

What revenue exposure did AKOVAZ create for Akorn?

AKOVAZ’s direct revenue exposure cannot be quantified from public company disclosures. Akorn’s public reporting did not separately identify sales, cost of goods, or profit for the product.

Its commercial importance can be assessed through four channels:

Hospital contract exposure

AKOVAZ was sold into institutional channels where contracts can produce recurring demand. Losing a hospital or GPO contract can reduce volume quickly because the product is usually protocol-driven.

Manufacturing utilization

The product could contribute to sterile-fill-finish utilization. Even a low-priced product may have value if it uses otherwise available manufacturing capacity.

Shortage-related pricing

Shortages can support temporary price improvement. That benefit is limited when multiple approved suppliers can restore production.

Bankruptcy-related impairment

Akorn’s distress could reduce the value of the AKOVAZ brand, customer relationships, inventory, and associated regulatory assets. A buyer would likely value the product based on transferable approvals, manufacturing rights, contracts, and supply capability rather than patent life.

What licensing deals or asset transactions affected AKOVAZ?

No major AKOVAZ-specific licensing transaction is widely identified as the primary driver of the product’s value. The more important transaction risk arose from Akorn’s bankruptcy proceedings and the disposition of company assets.

In an insolvency sale, a product can be transferred through:

Sale of the NDA or regulatory rights.
Sale of inventory.
Assignment of trademarks.
Transfer of manufacturing agreements.
Transfer of customer contracts.
Sale of equipment and production lines.
Sale of intellectual-property and quality records.

The transfer of an approved product does not guarantee uninterrupted supply. The acquiring party must maintain FDA compliance, establish release procedures, qualify suppliers, and manage post-approval responsibilities.

What generic launch scenarios exist for AKOVAZ?

Three scenarios are commercially plausible.

Scenario 1: Continued supply under a successor owner

A buyer maintains the product, preserves the FDA approval, and uses existing or replacement sterile manufacturing capacity. Market share could stabilize if hospitals accept the successor supplier.

Scenario 2: Product discontinuation and substitution

A successor decides that the product’s price and volume do not justify continued production. Hospitals migrate to other ephedrine sulfate suppliers, particularly if those suppliers can meet contract and shortage requirements.

Scenario 3: New entrants expand after supply disruption

Competitors increase production or submit new applications. Entry could pressure prices, but launch timing would depend on FDA approval, manufacturing capacity, and component availability.

The most likely economic outcome for a mature product is continued commodity pricing with episodic shortage premiums rather than durable margin expansion.

How does AKOVAZ compare with competing vasopressors?

AKOVAZ is used in a narrower perioperative setting than many hospital cardiovascular medicines. Its principal substitutes are not always direct pharmaceutical equivalents. Clinicians may select phenylephrine, norepinephrine, vasopressin, or other agents depending on the cause of hypotension, patient condition, and institutional protocol.

Product category	Primary use	Competitive relationship
Ephedrine sulfate injection	Anesthesia-related hypotension, especially when heart rate support is relevant	Direct category competition
Phenylephrine injection	Vasodilatory hypotension	Clinical substitute in many protocols
Norepinephrine injection	Severe or persistent hypotension	Escalation or broader critical-care substitute
Vasopressin injection	Selected vasodilatory shock settings	Limited clinical substitution
Epinephrine injection	Resuscitation and severe cardiovascular events	Not a routine direct substitute

Clinical substitution limits AKOVAZ’s pricing power. Hospitals can switch based on treatment protocols, inventory, and relative availability.

What is the outlook for AKOVAZ?

AKOVAZ’s long-term outlook is defined by supply reliability rather than patent life. The product has continuing clinical utility, but it is exposed to generic price competition, hospital purchasing pressure, sterile manufacturing constraints, and the consequences of Akorn’s bankruptcy.

The product could retain value if a financially stable owner controls an FDA-compliant manufacturing network and secures hospital distribution. Without that infrastructure, the AKOVAZ trademark and regulatory approval alone have limited commercial value.

Key Takeaways

AKOVAZ is ephedrine sulfate injection, a mature hospital generic used mainly during anesthesia.
Its market is driven by hospital demand, GPO contracts, shortage conditions, and manufacturing reliability.
No material composition, formulation, or method-of-use patent estate is associated with the product’s commercial position.
Paragraph IV litigation is not a central risk.
Akorn’s 2023 bankruptcy materially increased supply and counterparty risk.
AKOVAZ revenue and profitability were not separately disclosed.
Competitors can enter without overcoming a significant patent barrier, but sterile injectable manufacturing remains a practical barrier.
The product’s value depends on transferable FDA rights, supply capability, contracts, and quality infrastructure.
The likely long-term economics are commodity-like, with temporary pricing support during shortages.

FAQs

Is AKOVAZ still commercially available?

Availability depends on the manufacturer, presentation, inventory, and FDA shortage conditions. Akorn’s bankruptcy created substantial uncertainty around uninterrupted AKOVAZ supply.

Is AKOVAZ a branded drug or a generic drug?

AKOVAZ is a branded product name for ephedrine sulfate injection. Its active ingredient is an established generic medicine, and its commercial position does not depend on innovative-drug patent protection.

Does AKOVAZ have an Orange Book patent listing?

No material AKOVAZ patent listing is generally associated with the product’s market protection. The FDA Orange Book remains the controlling source for current patent and exclusivity entries. (FDA, n.d.-b)

Can hospitals substitute phenylephrine for AKOVAZ?

Clinicians may use phenylephrine or other vasopressors as alternatives depending on the patient’s hemodynamic status, heart rate, anesthesia protocol, and hospital formulary.

What is the investment value of AKOVAZ?

Its value is primarily tied to regulatory approval, transferable manufacturing capability, hospital contracts, and supply reliability. Product-level investment value cannot be calculated from public disclosures because AKOVAZ revenue and profit were not separately reported.

References

Akorn Operating Company LLC. (2023). Voluntary petitions for relief under Chapter 11 of the United States Bankruptcy Code. United States Bankruptcy Court.
United States Bankruptcy Court for the District of Delaware. (2023). In re Akorn Operating Company LLC and affiliated debtors, Chapter 11 case materials.
U.S. Food and Drug Administration. (2016). AKOVAZ (ephedrine sulfate injection) prescribing information. FDA.
U.S. Food and Drug Administration. (n.d.-a). Drug shortages database. https://www.accessdata.fda.gov/scripts/drugshortages/
U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	446
Drug Prices:	Drug price information for AKOVAZ
What excipients (inactive ingredients) are in AKOVAZ?	AKOVAZ excipients list
DailyMed Link:	AKOVAZ at DailyMed

Drug Class	Norepinephrine Releasing Agent alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

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