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

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	HYPERSTAT	diazoxide	INJECTABLE;INJECTION	016996-001	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: November 9, 2026

Hyperstat was a branded injectable formulation of diazoxide used for rapid blood-pressure reduction in severe hypertension. Its commercial trajectory has ended in the United States: the brand is no longer an active growth product, no current Hyperstat revenue is publicly reported, and the clinical market has shifted toward alternative intravenous antihypertensives and oral diazoxide products for congenital hyperinsulinism. The remaining commercial opportunity is tied to generic diazoxide supply, hospital formulary demand, and the separate Proglycem market rather than the Hyperstat brand.

What is Hyperstat and what drug does it contain?

Hyperstat contains diazoxide, a potassium-channel opener that relaxes vascular smooth muscle and reduces systemic vascular resistance. The historic Hyperstat product was an injectable formulation used for short-term treatment of acute severe hypertension when rapid blood-pressure reduction was required.

Product	Active ingredient	Historical route	Primary use	Current commercial position
Hyperstat	Diazoxide	Intravenous injection	Severe hypertension	Discontinued or no longer actively marketed as a U.S. branded product
Proglycem	Diazoxide	Oral suspension	Hypoglycemia caused by hyperinsulinism	Active branded diazoxide product
Generic diazoxide injection	Diazoxide	Intravenous injection	Severe hypertension	Limited and institution-dependent availability
Modern alternatives	Nicardipine, clevidipine, labetalol, esmolol and others	Intravenous	Hypertensive emergencies	Dominant hospital alternatives

The historical Hyperstat formulation should not be confused with Proglycem. Both contain diazoxide, but their routes, indications, customers and economic profiles differ.

When did Hyperstat lose exclusivity?

Hyperstat’s original product protection expired decades ago. The product was approved in the early era of modern drug regulation, before the current commercial importance of formulation patents, pediatric exclusivity and complex-product lifecycle strategies.

The relevant commercial event was generic substitution and market displacement, not a recent patent cliff. The public record does not identify a current, enforceable Hyperstat patent estate that would support branded exclusivity in the U.S. market.

Patent and exclusivity timeline

Event	Approximate status
Diazoxide introduced as an antihypertensive	1970s
Hyperstat marketed in the United States	Historical
Original product exclusivity	Expired
Brand competition from generic diazoxide	Developed after original brand protection
Current Orange Book position	No active branded Hyperstat growth franchise publicly evident
Current market risk	Supply continuity, substitution and clinical obsolescence

Diazoxide itself is an old small molecule. Any remaining patent value would have to come from a specific formulation, manufacturing process, delivery system or new use. The original Hyperstat product does not have the profile of a modern patent-protected specialty medicine.

What is the Orange Book status of Hyperstat?

Hyperstat does not appear to have a meaningful current Orange Book position comparable with actively marketed branded drugs. FDA Orange Book listings distinguish active products from discontinued products and identify patents that are submitted for marketed products. A discontinued brand generally does not provide an active commercial barrier to an ANDA applicant unless an associated patent remains enforceable and relevant to a marketed reference product.

The practical conclusion is that Hyperstat does not appear to create a current U.S. patent barrier to generic diazoxide injection. Product availability, manufacturing economics and hospital purchasing contracts are more important than Orange Book exclusivity.

FDA’s discontinued-drug framework also matters. A product can be listed as discontinued for commercial reasons without a safety withdrawal. That distinction is relevant to Hyperstat because the product’s commercial disappearance does not establish that diazoxide as a molecule was withdrawn for safety reasons. [1]

What patents protect Hyperstat and diazoxide products?

No material active Hyperstat patent estate is publicly apparent from the historical product profile. The likely protection layers were:

Original compound and product patents, now expired.
Historical formulation and manufacturing claims, if any, with expired terms.
Product labeling and regulatory status, which do not create permanent exclusivity.
Potential later patents covering oral diazoxide formulations or pediatric use, generally associated with Proglycem rather than Hyperstat.

Diazoxide’s small-molecule status sharply limits the relevance of biosimilar law. Biosimilar competition is not applicable because Hyperstat is not a biologic. Any competition would arise through generic drug pathways, including ANDAs or, depending on product characteristics, other FDA abbreviated pathways.

Are formulation patents still commercially important?

Formulation patents could matter if a company developed a new injectable presentation, improved stability, ready-to-use packaging or a differentiated oral suspension. Such claims would protect the specific formulation, not diazoxide generally.

For Hyperstat itself, no widely recognized active formulation patent has created a current branded moat. The likely barriers are technical and economic:

Sterile injectable manufacturing.
Stability and container-closure validation.
Low-volume hospital demand.
Regulatory requirements for injectable quality.
Limited commercial incentive for multiple manufacturers.
Hospital preference for newer titratable antihypertensive products.

These factors can produce supply fragility without creating durable pricing power.

How has the Hyperstat market changed?

The market for acute hypertensive treatment has moved toward titratable intravenous medicines with predictable onset and offset. Nicardipine and clevidipine are widely used in intensive-care settings because infusion rates can be adjusted continuously. Labetalol and esmolol address specific clinical situations, including sympathetic overactivity and acute aortic syndromes.

Diazoxide has several disadvantages in this setting:

Less precise blood-pressure titration.
Risk of excessive hypotension.
Sodium and fluid-retention effects.
Tachycardia and other vasodilator-related effects.
Reduced familiarity among current hospital prescribers.
Availability of newer ICU protocols and products.

These clinical factors weakened Hyperstat independently of patent expiration. The product’s commercial decline therefore reflects both genericization and therapeutic substitution.

What is the financial trajectory of Hyperstat?

Hyperstat has no publicly reported standalone revenue trajectory. Historical sales were likely included in the accounts of its manufacturer and were not disclosed as a separate reporting segment. Since the brand is no longer a visible active product, current Hyperstat revenue should be treated as negligible or zero in standard pharmaceutical market models unless a regional distributor still sells a product under the name.

Financial driver	Impact on Hyperstat
Patent expiration	Eliminated branded pricing power
Generic substitution	Reduced unit price
Hospital use	Narrowed demand to specialized acute-care settings
Therapeutic substitution	Reduced prescribing volume
Manufacturing complexity	Limited supplier participation
Brand discontinuation	Removed promotional and commercial support
Current revenue visibility	No reliable standalone public disclosure

The economic value has migrated away from the historical Hyperstat brand. Any residual market value would be associated with generic diazoxide injection supply, institutional contracts or a relaunch under a different commercial name.

What companies are challenging or replacing Hyperstat?

No major current Paragraph IV litigation involving Hyperstat is publicly associated with a live branded franchise. The relevant competitive set consists of substitute products rather than direct patent challengers.

Competitor	Category	Competitive effect
Nicardipine injection	Calcium-channel blocker	Major substitute for titratable ICU blood-pressure control
Clevidipine injection	Ultra-short-acting calcium-channel blocker	Premium substitute in critical-care settings
Labetalol injection	Alpha/beta blocker	Alternative for many hypertensive emergencies
Esmolol injection	Short-acting beta blocker	Used where heart-rate control is central
Generic diazoxide	Direct molecule-level competitor	Competes on supply and price if available
Oral diazoxide products	Same molecule, different indication	Not a direct replacement for acute IV therapy

The market is therefore defined by therapeutic substitution, not a current patent contest over Hyperstat.

Are there Paragraph IV challenges, settlements or patent litigation?

No current, material Paragraph IV campaign or settlement involving the Hyperstat brand is evident from the public product history. The brand’s age and discontinued status reduce the commercial value of a Paragraph IV challenge.

A generic applicant would typically assess:

Whether an active reference product exists.
Whether FDA permits an ANDA pathway.
Whether injectable sameness can be demonstrated.
Whether listed patents remain unexpired.
Whether a market can support sterile manufacturing costs.
Whether hospital buyers will accept the product.

For Hyperstat, these questions are more important than litigation risk. The absence of a major settlement record is consistent with a mature, low-revenue product rather than with strong exclusivity.

What FDA regulatory status applies to Hyperstat?

Hyperstat is a historical diazoxide product. FDA regulatory status should be distinguished among:

The original Hyperstat brand.
Generic diazoxide injection products.
Proglycem oral suspension.
Other diazoxide products in foreign markets.

FDA-approved status is product-specific. Approval of Proglycem does not establish that Hyperstat injection remains marketed, and historical approval of Hyperstat does not establish current commercial availability.

The clinically important active diazoxide franchise is Proglycem, which is used for hypoglycemia associated with hyperinsulinism. That market has a different demand profile, including pediatric and rare-disease treatment, and may support higher value per patient than the former acute-hypertension product.

How strong is the Hyperstat patent estate?

The Hyperstat patent estate is weak from a current investment perspective.

Factor	Assessment
Active composition-of-matter patent	No meaningful current protection expected
Active brand exclusivity	None apparent
Orange Book barrier	Limited or absent
Generic entry risk	High
Biosimilar risk	Not applicable
Manufacturing barrier	Moderate for sterile injection
Clinical differentiation	Low
Pricing power	Low
Litigation leverage	Low
Commercial growth potential	Minimal

Manufacturing difficulty can support temporary supply constraints, but it does not equal patent strength. A supplier with validated sterile capacity may gain short-term share without obtaining durable exclusivity.

What generic launch scenarios exist for Hyperstat?

Three scenarios are commercially plausible:

Continued limited generic supply

A small number of manufacturers supply diazoxide injection to hospitals. Prices remain sensitive to shortages, procurement contracts and production interruptions. This is the most likely structure for a legacy injectable product.

Complete market exit

Manufacturers discontinue the product because demand is too small to justify sterile manufacturing, regulatory maintenance and quality-system costs. Hospitals then rely on therapeutic substitutes.

Specialty relaunch

A company acquires or redevelops the product, potentially using a new presentation or an alternative regulatory strategy. A relaunch would require a clear supply or clinical rationale and would face competition from established intravenous antihypertensives.

A return to the historical Hyperstat brand would not by itself restore pricing power. The product would need differentiated availability, packaging, clinical positioning or distribution.

How does Hyperstat compare with Proglycem?

Attribute	Hyperstat	Proglycem
Active ingredient	Diazoxide	Diazoxide
Route	Injectable	Oral suspension
Historical indication	Severe hypertension	Hyperinsulinism-related hypoglycemia
Customer base	Hospitals and intensive-care units	Specialty physicians, pediatric centers and chronic-care patients
Commercial status	Historical or discontinued brand	Active branded product
Patent value	Limited	Potentially greater value from formulation, labeling and orphan-disease positioning
Revenue model	Acute hospital use	Chronic or recurrent rare-disease treatment
Biosimilar exposure	Not applicable	Not applicable
Generic exposure	High	Depends on product and regulatory pathway

Proglycem is the more commercially relevant diazoxide product. Hyperstat should be valued as a legacy product or supply opportunity, not as a growing pharmaceutical franchise.

What is the geographic coverage of Hyperstat?

Hyperstat’s historical relevance is primarily associated with the United States. Diazoxide products and brand names may differ by jurisdiction, and current availability must be assessed country by country. Patent rights, marketing authorizations, reimbursement and hospital procurement are territorial.

No global Hyperstat growth platform is evident. International opportunities would depend on local registration, sterile manufacturing capacity and the presence of generic or alternative antihypertensive products.

Key Takeaways

Hyperstat was a historical injectable diazoxide product for severe hypertension.
Its original exclusivity expired long ago.
No material active Hyperstat patent estate or current branded Orange Book moat is apparent.
The product faces strong substitution from nicardipine, clevidipine, labetalol and esmolol.
Hyperstat has no publicly reported standalone current revenue.
Generic supply economics, not patent litigation, determine residual market value.
Biosimilar competition is irrelevant because diazoxide is a small molecule.
Proglycem is the commercially relevant active diazoxide franchise, with a different indication and customer base.
The likely financial trajectory for Hyperstat is flat at negligible levels or continued market exit.

FAQs

Is Hyperstat still available in the United States?

Hyperstat is not generally recognized as an actively marketed U.S. branded product. Any current diazoxide injection availability is more likely to involve generic or institution-specific supply.

Is Hyperstat the same as Proglycem?

Both contain diazoxide, but Hyperstat was an injectable product for severe hypertension, while Proglycem is an oral suspension for hyperinsulinism-related hypoglycemia.

Does Hyperstat have biosimilar competition?

No. Biosimilars apply to biologic products. Diazoxide is a small-molecule drug and competes through generic-drug pathways.

Could a company relaunch Hyperstat?

A relaunch is technically possible but commercially difficult. The product would face established intravenous antihypertensives, low demand and the cost of maintaining sterile injectable manufacturing.

What is the investment case for Hyperstat?

The historical brand has little apparent standalone investment value. Any opportunity would be linked to generic diazoxide supply, shortage-driven pricing, contract manufacturing or a broader diazoxide portfolio that includes Proglycem.

References

U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
DailyMed. (n.d.). Diazoxide and Proglycem prescribing information. National Library of Medicine. https://dailymed.nlm.nih.gov/
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	100
Patent Applications:	3,802
DailyMed Link:	HYPERSTAT at DailyMed

HYPERSTAT Drug Patent Profile

When do Hyperstat patents expire, and what generic alternatives are available?

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hyperstat

AI Deep Research

Questions you can ask:

Summary for HYPERSTAT

US Patents and Regulatory Information for HYPERSTAT

# HYPERSTAT (DIAZOXIDE) Market Dynamics, Patent Status, and Financial Trajectory