STIMATE Drug Patent Profile

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

Stimate is a drug marketed by Ferring Pharms Inc and is included in one NDA.

The generic ingredient in STIMATE is desmopressin acetate. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Stimate

A generic version of STIMATE was approved as desmopressin acetate by MEITHEAL on October 15^th, 1997.

Summary for STIMATE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	4
Patent Applications:	237
Drug Prices:	Drug price information for STIMATE
What excipients (inactive ingredients) are in STIMATE?	STIMATE excipients list
DailyMed Link:	STIMATE at DailyMed

See drug prices for STIMATE

Recent Clinical Trials for STIMATE

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

Sponsor	Phase
Genentech, Inc.	Phase 4
Indiana Hemophilia &Thrombosis Center, Inc.	Phase 4
St. Michael's Hospital, Toronto	Phase 4

See all STIMATE clinical trials

Pharmacology for STIMATE

Drug Class	Factor VIII Activator Vasopressin Analog
Physiological Effect	Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

US Patents and Regulatory Information for STIMATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	STIMATE	desmopressin acetate	SPRAY, METERED;NASAL	020355-001	Mar 7, 1994		DISCN	No	No
Ferring Pharms Inc	STIMATE (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	020355-002	Oct 24, 2007		DISCN	Yes	No

STIMATE Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 28, 2026

STIMATE is a niche desmopressin acetate nasal spray used primarily for mild hemophilia A and type 1 von Willebrand disease. Its commercial trajectory changed sharply after the 2020 recall of all lots for potential superpotency. Ferring Pharmaceuticals has not restored normal U.S. availability, and the product has no meaningful remaining regulatory exclusivity or visible patent barrier. The principal commercial issue is supply failure, not loss of demand.

Public disclosures do not report STIMATE revenue separately. Ferring is privately held, and company financial statements do not provide product-level sales. The product’s value is therefore best assessed through its clinical role, supply status, substitutes, reimbursement position, and replacement risk rather than standalone revenue.

What is STIMATE and how does it generate pharmaceutical demand?

STIMATE is the U.S. brand name for desmopressin acetate nasal spray, supplied at 1.5 mg/mL. Desmopressin increases plasma concentrations of von Willebrand factor and factor VIII in responsive patients. The product is used to reduce bleeding during minor procedures and to manage bleeding episodes in selected patients with:

• Mild hemophilia A
• Type 1 von Willebrand disease
• Other limited hematologic indications under specialist supervision

STIMATE has a narrow patient population and is not a chronic mass-market medicine. Demand comes from hematology centers, specialty pharmacies, hospitals, and patients who require a rapid, nonintravenous hemostatic option.

The product’s economic value is higher than its unit volume suggests. A responsive patient can avoid factor replacement, infusion-center utilization, or hospital treatment for selected events. That creates clinical switching costs even though alternative desmopressin products exist.

What is the FDA regulatory status of STIMATE?

STIMATE was approved under U.S. New Drug Application 019955. Ferring Pharmaceuticals is identified in the U.S. prescribing information as the product manufacturer and sponsor.[1]

FDA milestones and supply timeline

Date	Event	Commercial effect
1994	FDA approval of STIMATE nasal spray	Established the branded U.S. product
June 2020	Ferring recall of all STIMATE lots	Removed available commercial inventory
2020 onward	FDA drug-shortage listing and supply disruption	Forced substitution to injectable or oral desmopressin and factor products
2021-2024	Continued lack of dependable commercial supply	Reduced brand revenue to effectively zero or immaterial levels in the U.S.

The 2020 recall followed manufacturing and quality concerns involving product potency. FDA communications warned that patients could receive excessive desmopressin exposure, creating a risk of water retention and hyponatremia.[2] Desmopressin-associated hyponatremia can cause seizures, coma, or death in severe cases, making potency control and dosing accuracy commercially decisive.

The product should not be treated as normally marketed merely because its NDA remains approved. Approved status and commercial availability are separate issues. FDA shortage and discontinuation records are more relevant to near-term market access than the historical approval date.

When did STIMATE lose exclusivity?

STIMATE has no meaningful remaining market exclusivity. Its original regulatory exclusivity period expired decades ago, and the underlying desmopressin nasal-spray technology is mature.

The product is a small-molecule drug, not a biologic. It therefore has no biosimilar exclusivity framework. Any competitor would generally pursue an abbreviated new drug application, a suitability-based pathway where applicable, or a new NDA depending on formulation, device, reference-product status, and FDA requirements.

What is the Orange Book status of STIMATE?

The Orange Book is the relevant source for listed patents and regulatory exclusivity associated with NDA 019955.[3] Publicly available Orange Book information does not indicate a commercially meaningful, unexpired patent estate that would block a competing desmopressin nasal spray.

The practical protection profile is:

Protection category	STIMATE position
Active-ingredient patent	Expired
Original nasal-spray technology	Expired or commercially nonblocking
New chemical entity exclusivity	Expired
Pediatric exclusivity	No current commercial relevance
Orphan-drug exclusivity	Not the principal protection mechanism for STIMATE
Listed formulation patent	No material unexpired barrier identified
Biosimilar exclusivity	Not applicable
FDA approval	Persists, but does not prevent generic competition

No current patent litigation is publicly associated with STIMATE that would materially delay a generic entrant. The commercial barrier is product development and manufacturing reliability, not patent enforcement.

What formulations are protected by STIMATE-related patents?

The important formulation is a metered-dose desmopressin nasal spray. Its competitive complexity lies in the delivery system, dose uniformity, container-closure system, preservative profile, and stability characteristics.

A competitor would need to demonstrate that its product delivers a therapeutically comparable dose through a nasal device. FDA review can examine:

• Desmopressin concentration
• Delivered volume per actuation
• Spray content uniformity
• Priming and repriming performance
• Container-closure integrity
• Stability over the labeled shelf life
• Device performance at the beginning and end of use
• Risk of dose escalation caused by pump malfunction or concentration drift

These requirements create a manufacturing and regulatory barrier even without enforceable patent protection. A generic applicant cannot assume that a conventional desmopressin nasal formulation will receive approval solely because the active ingredient is old.

The 2020 recall raised the commercial importance of quality systems. For a replacement manufacturer, FDA scrutiny of potency, filling, device assembly, release testing, and postmarket controls would likely be central to approval and launch execution.

How did the 2020 recall affect STIMATE’s financial trajectory?

The recall converted STIMATE from a stable niche product into an unavailable product.

Revenue trajectory

Period	Revenue outlook	Main driver
Before 2020	Recurring specialty-product revenue	Established hematology use and limited competition
2020	Abrupt decline	Recall of all lots
2021-2022	Minimal or no U.S. product revenue	No dependable commercial supply
2023-2024	No demonstrated recovery	Ongoing availability constraints and substitution

Ferring does not disclose STIMATE-specific revenue, unit sales, gross margin, or remediation costs. The product likely generated modest absolute revenue relative to Ferring’s broader portfolio, but it occupied a specialized clinical position with limited direct substitutes.

The recall also imposed costs beyond lost sales:

• Product recall and destruction
• Investigation of manufacturing deviations
• Corrective and preventive actions
• Potential equipment or process redesign
• Regulatory engagement
• Inventory write-offs
• Customer-service and medical-affairs costs
• Loss of prescriber confidence

The financial case for restarting production is difficult. A manufacturer must fund remediation for a low-volume product while accepting heightened liability and quality-control requirements. That economics can favor permanent discontinuation even where clinical demand remains.

Which companies are challenging STIMATE in the market?

No major generic company has been publicly identified as having launched a directly substitutable U.S. desmopressin nasal spray that restores STIMATE’s former role.

Competition comes mainly from therapeutic substitutes rather than direct generic challengers.

Desmopressin substitutes

Product or category	Company examples	Main use	Competitive relationship
DDAVP injection	Various suppliers and hospital channels	Hemophilia A and von Willebrand disease	Closest active-substance substitute, but requires injection
Oral desmopressin tablets	Generic manufacturers	Selected desmopressin indications	Less direct replacement for nasal hemostatic use
Desmopressin sublingual products	Market-dependent	Primarily other desmopressin indications	Not a straightforward replacement
Factor VIII concentrates	Bayer, Takeda, BioMarin and others, depending on product	Hemophilia A	Higher-cost replacement for patients who cannot use desmopressin
VWF-containing concentrates	CSL Behring, Takeda and others	Von Willebrand disease	Used when desmopressin is inadequate or contraindicated
Recombinant VWF	Takeda’s VONVENDI	Von Willebrand disease	Alternative for more serious or nonresponsive cases
Emicizumab	Roche	Hemophilia A prophylaxis	Reduces reliance on factor VIII in eligible patients but does not replace acute desmopressin use

The principal direct substitute is injectable desmopressin. Its disadvantages include administration burden, training requirements, lower convenience, and greater dependence on clinical infrastructure. Factor and VWF products provide stronger hemostatic replacement but have materially higher acquisition costs and more complex administration.

What generic entry risks exist for STIMATE?

A generic STIMATE launch is legally possible because the product has no apparent blocking patent estate. The main risks are regulatory, technical, and commercial.

Generic launch scenarios

Scenario 1: Ferring restarts STIMATE

This would preserve the brand’s clinical recognition but require validated manufacturing capacity and renewed physician confidence. A restart would likely face concentrated demand from bleeding-disorder centers rather than broad retail volume.

Scenario 2: A generic nasal spray launches

A generic entrant could capture demand quickly if it demonstrates equivalent dose delivery and secures reliable supply. The first credible entrant would have pricing power in the short term because the market has experienced a prolonged shortage.

Scenario 3: Nasal STIMATE remains unavailable

In this scenario, the market continues to migrate toward injectable desmopressin, factor products, and VWF replacement. Prescriber habits would gradually reset, reducing the recoverable market even if STIMATE returns.

Scenario 4: A replacement product uses a different device or concentration

A new NDA could support a modernized desmopressin nasal product, but that path would require a broader regulatory package and higher development costs. The product could compete on dose reliability, device usability, or supply assurance.

How strong is the STIMATE patent estate?

The patent estate is weak as a current exclusivity asset.

Strength assessment

Factor	Assessment
Composition-of-matter protection	None of current commercial value
Formulation protection	No material unexpired barrier identified
Device protection	Potential historical relevance, but no known blocking position
Method-of-use protection	Not a significant current barrier
Regulatory exclusivity	Expired
Litigation leverage	Low
Manufacturing know-how	More relevant than patent rights
Brand and physician familiarity	Stronger than formal IP protection

The remaining defensibility is operational. A manufacturer with validated nasal-spray capacity, compliant quality systems, and hematology distribution relationships could compete without acquiring STIMATE patents.

What patent litigation and settlement agreements affect STIMATE?

No material active patent litigation or public Paragraph IV settlement agreement involving STIMATE has been identified through the available FDA and public patent records.

Because the relevant exclusivity periods have expired and the product has been commercially unavailable, a Paragraph IV challenge would have limited strategic importance unless tied to a new formulation, device, or manufacturing patent. A future applicant would more likely face FDA development requirements than a patent lawsuit.

Is there a licensing deal for STIMATE?

No material current licensing transaction involving STIMATE has been publicly disclosed. Ferring is the relevant commercial and manufacturing company in U.S. product materials. Public company-level information does not identify a separate licensee with reported STIMATE revenue or a marketed successor.

The absence of a disclosed licensing transaction matters commercially. A distressed or discontinued product can be attractive to a specialty manufacturer only if the buyer can obtain transferable regulatory rights, reliable manufacturing technology, and sufficient patient demand. No public transaction demonstrates that such a transfer has occurred.

What is the competitive landscape for desmopressin in bleeding disorders?

STIMATE competes in a narrow segment of the hemostasis market. Its position depends on patient responsiveness and safety suitability.

Desmopressin is generally most valuable for patients who respond to a documented test dose and who can comply with fluid restriction and sodium-monitoring precautions. It is less suitable for patients with cardiovascular risk, seizure risk, hyponatremia risk, or inadequate response.

Factor concentrates and VWF products have higher treatment costs but provide more predictable replacement. Their use expands when:

• Desmopressin response is inadequate
• The bleeding event is severe
• Surgery requires sustained hemostatic coverage
• Repeated dosing is inappropriate
• The patient has contraindications to desmopressin

This competitive structure limits STIMATE’s total market size but supports recurring clinical demand when supply is reliable.

What is the investment and commercial outlook for STIMATE?

STIMATE has low direct revenue visibility and high supply-recovery risk. Its upside comes from unmet demand created by the prolonged shortage, not from market expansion.

A returning product would have several advantages:

• Established brand recognition
• Existing clinical protocols
• A known active ingredient
• A defined specialty market
• Limited direct nasal competition

The disadvantages are substantial:

• No meaningful patent moat
• Small addressable market
• High quality-system expectations
• Potential liability from potency failure
• Substitution to established alternatives
• Need to rebuild distribution and prescriber confidence
• Possible payer pressure if a generic launches

The most likely commercial result is a fragmented market. Ferring could retain a premium brand position if it restores supply first, while a generic entrant could pressure price and capture institutional accounts. If no nasal product returns, injectable desmopressin and factor replacement will retain the displaced demand.

Key Takeaways

• STIMATE is a niche desmopressin acetate nasal spray for mild hemophilia A and type 1 von Willebrand disease.
• The 2020 recall caused the central disruption in its financial trajectory.
• Ferring does not publicly disclose STIMATE revenue, units, or product-level profitability.
• The product has no meaningful remaining regulatory exclusivity or visible blocking patent estate.
• No material active Paragraph IV litigation or settlement agreement is publicly associated with STIMATE.
• Injectable desmopressin is the closest substitute, while factor VIII and VWF products compete in higher-acuity cases.
• A future generic nasal spray would face device, dose-uniformity, stability, and manufacturing hurdles.
• The principal asset is clinical familiarity and unmet demand, not patent protection.
• The commercial outlook depends on reliable supply restoration and the ability to prevent further quality failures.

FAQs

Is STIMATE still available in the United States?

STIMATE has remained commercially unavailable or severely supply constrained following the 2020 recall. Its approval status does not establish normal market availability.

Can DDAVP injection replace STIMATE?

DDAVP injection contains desmopressin and is the closest therapeutic substitute, but it is not automatically interchangeable with STIMATE. Dose, route, administration requirements, and clinical monitoring differ.

Does STIMATE have a generic equivalent?

No widely marketed U.S. generic nasal product has restored the same commercial role as STIMATE based on the available public record through 2024.

Could a company launch a generic STIMATE without a patent license?

Potentially. The relevant issue is FDA approval and any unexpired listed patents, not a license to Ferring’s expired historical rights. A new applicant would still need to satisfy FDA requirements for formulation and device performance.

Why is STIMATE commercially important if its patient population is small?

The product can reduce the need for factor replacement or intravenous treatment in responsive patients. Its clinical value per treated patient can therefore exceed what its limited unit volume would suggest.

References

1. Ferring Pharmaceuticals Inc. (2020). STIMATE (desmopressin acetate) nasal spray prescribing information. U.S. Food and Drug Administration.

2. U.S. Food and Drug Administration. (2020). Ferring Pharmaceuticals issues nationwide recall of all lots of STIMATE nasal spray due to potential superpotency. FDA Drug Safety Communication.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.

4. U.S. Food and Drug Administration. (2024). Drug shortages: Desmopressin acetate nasal spray. FDA Drug Shortages Database.

5. National Hemophilia Foundation. (2021). MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. National Hemophilia Foundation.