NOCDURNA Drug Patent Profile

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

Nocdurna is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-three patent family members in eighteen countries.

The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nocdurna

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

Summary for NOCDURNA

International Patents:	93
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
Patent Applications:	237
Drug Prices:	Drug price information for NOCDURNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOCDURNA
What excipients (inactive ingredients) are in NOCDURNA?	NOCDURNA excipients list
DailyMed Link:	NOCDURNA at DailyMed

See drug prices for NOCDURNA

Recent Clinical Trials for NOCDURNA

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

Sponsor	Phase
Ferring Pharmaceuticals	Phase 2

See all NOCDURNA clinical trials

US Patents and Regulatory Information for NOCDURNA

NOCDURNA is protected by five US patents.

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	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No

Expired US Patents for NOCDURNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018

International Patents for NOCDURNA

See the table below for patents covering NOCDURNA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	039092	FORMA DE DOSIFICACION FARMACEUTICA DE DESMOPRESINA, FABRICACION Y USO
Argentina	039794	FORMULACIONES FARMACEUTICAS DE DESMOPRESINA
Argentina	107948	FORMULACIONES FARMACÉUTICAS
Austria	333886
Australia	2002337419	SUBLINGUAL PHARMACEUTICAL FORMULATION OF DESMOPRESSIN

Supplementary Protection Certificates for NOCDURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2712622	PA2017001	Lithuania		PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
2712622	122017000006	Germany		PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; AUTHORISATION NO/DATE: 94726.00.00 20160901; 94725.00.00 20160901; BE497271 20160504; BE497280 20160504
2712622	LUC00015	Luxembourg		PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
3225249	CA 2019 00023	Denmark		PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504

Last updated: July 29, 2026

NOCDURNA market dynamics and financial trajectory: revenue drivers, payer adoption, exclusivity risks, and competitive pressure

NOCDURNA (desmopressin acetate) is a niche, specialty branded product with revenue tied to late-stage nocturia prescribing, payer step edits, and dose/formulation switching. Financial trajectory is shaped by (1) route-and-dose differentiation versus generic desmopressin tablets, (2) the absence or presence of competing extended-release and intranasal/other formats in payers’ formularies, and (3) patent and exclusivity status that determines the timeline for generic or authorized substitutes.

Key business lens: Nocturia is a fragmented market where payer policy and clinical guideline uptake drive adoption more than raw population prevalence. NOCDURNA’s financial path is therefore more sensitive to managed care placement, prior authorization and quantity limits, and persistence at target doses than to broad epidemiology.

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What is NOCDURNA (desmopressin acetate) and how does it fit the nocturia market?

NOCDURNA is a desmopressin acetate product used for nocturia (adult patients with nocturnal urination). Desmopressin is an antidiuretic hormone analog that reduces urine production overnight, making it distinct from non-hormonal nocturia approaches (for example, alpha blockers for BPH-related storage symptoms, and diuretics timing strategies).

Commercial positioning variables

• Patient selection: Best fit is typically patients with nocturnal polyuria. Adoption increases when prescribers can identify that phenotype and when payers accept the indication with supportive documentation.
• Prescribing channel: Geriatrics, urology, and primary care account for disproportionate share of initial volume. Specialty status affects access through prior authorization complexity.
• Therapy switching: Markets evolve when prescribers move patients from cheaper alternatives (generic desmopressin formulations) into NOCDURNA for perceived tolerability or dosing convenience. That is the core lever for incremental revenue.

How does NOCDURNA compare with generic desmopressin products?

Competitive baseline

• Generic desmopressin products exist across different dosage forms and routes depending on geography and approval history. Payer economics typically favor generics once available at scale.
• NOCDURNA’s brand economics depend on payers accepting a premium over lowest-cost alternatives. That premium erodes after generic substitution becomes easier (formulary placement, pharmacy benefit manager routing, and patent cliffs).

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What drives NOCDURNA revenue growth or decline: pricing, access, dosing, and persistence?

NOCDURNA’s financial trajectory is generally determined by a standard set of managed-care and prescribing drivers.

1) Access and formulary depth

• Formulary tiering: Moving from non-preferred to preferred status typically increases net sales via reduced pharmacy friction and lower patient out-of-pocket costs.
• Prior authorization (PA) and quantity limits (QL): PA adds administrative cost and reduces conversion from new starts. QLs constrain dose titration behavior and can depress persistence.

2) Net price dynamics

• Brand price is compressed by payer rebates and contracting with PBMs. Net sales trend diverges from list price if contracts are renegotiated, competitors gain formulary placement, or utilization patterns shift.

3) Dosing strategy and titration

• Nocturia treatment is sensitive to dose timing and patient response. Products that support titration with fewer adverse events tend to sustain persistence.
• If prescribers treat NOCDURNA as an episodic attempt rather than a stable therapy, volume can plateau quickly.

4) Persistence and discontinuation

• Desmopressin therapies carry risks related to hyponatremia and tolerability. Discontinuation patterns can limit long-term net sales even when initial uptake is strong.

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When does NOCDURNA lose exclusivity, and what generic entry risks exist?

Exclusivity loss and generic entry risks depend on NOCDURNA’s FDA exclusivity period, patent expiry dates, and whether Paragraph IV challenges are filed. These timelines determine whether generics can enter at launch, enter later at a “skinny” carve-out, or avoid infringement via design-around.

Business impact pathway

• Pre-expiry: Manufacturers compete for formulary position and prescriber mindshare.
• At-expiry: Generic pressure hits hardest when multiple manufacturers are positioned and when PBMs can route to lower-cost products without extensive PA.
• Post-expiry: Net sales often fall rapidly in branded assets with substitution-friendly policy.

What patent and exclusivity events typically matter for NOCDURNA?

In branded desmopressin products, the key infringement and exclusivity levers usually include:

• Composition-of-matter patents (active ingredient and specific chemical form).
• Formulation and dosage-form patents (delivery system, stability, release or handling characteristics).
• Method-of-use patents (specific nocturia treatment regimens).
• Regulatory exclusivity (application-based exclusivity, if applicable).

Generic entry risk rises if:

• Brand patents are narrow or vulnerable to invalidity arguments.
• The Orange Book listing set is small or concentrated in easily designed-around claims.
• Patent litigation ends without “no-entry” provisions binding competitors at launch.

Generic entry risk falls if:

• Multiple unexpired blocking patents cover core composition/formulation claims.
• Litigation settlement imposes a delayed launch date for generic challengers.

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What is the Orange Book status of NOCDURNA and how many patents are listed?

The Orange Book determines the practical patent landscape for generic eligibility. It is the basis for:

• Paragraph IV challenge targeting specific Orange Book listings.
• “Generic at risk” assessment tied to which listed patents are asserted as blocking.

Market relevance

• The number and type of Orange Book listings correlate with generic launch speed and settlement likelihood.
• A concentrated listing set often implies higher odds of rapid at-risk entry once the lead patent expires.

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Has NOCDURNA faced Paragraph IV challenges or patent litigation, and how does that affect market timing?

Patent litigation affects not only launch calendars but also payer behavior during the uncertainty window.

What usually changes during litigation

• PBM contracting: Some PBMs accelerate switching to generics once a strong invalidity or non-infringement posture emerges.
• Brand rebates: The brand may increase rebates or expand patient access to preserve volume through the final years.
• Manufacturers: Competing generics coordinate with counsel and manufacturing readiness. Multiple “ready-to-launch” players intensify price pressure at expiry.

Commercial outcome

• Settlements with delayed entry produce a “cliff-late” profile where net sales hold longer, then drop around the settlement date rather than the first patent expiry.
• Win-or-loss on core claims determines whether subsequent challenges remain viable.

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How strong is the patent estate for NOCDURNA: composition, formulation, method-of-use

Patent estate strength is typically measured by breadth and survival probability across key claim classes.

High-strength profile

• Multiple independent claim sets covering composition, formulation, and key dosing/use parameters.
• Several unexpired patents distributed across jurisdictions and active claim scope.

Low-strength profile

• A limited number of blocking claims.
• Narrow claim language limited to a specific formulation characteristic or dosing schedule.

Business translation

• A strong estate supports premium net pricing for longer.
• A weaker estate forces earlier net price concessions and earlier payer switching.

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How does NOCDURNA compare with other nocturia therapies in payer economics and adoption?

Nocturia is treated with a mix of:

• Desmopressin-based therapies (antidiuretic hormone analogs)
• BPH-related symptom approaches (where applicable)
• Antimuscarinics and beta-3 agonists in overactive bladder pathways
• Diuretic timing adjustments and behavioral interventions

Economic comparison logic

• When desmopressin competes primarily against generics in the same class, the deciding factor is formulary tier and PA friction.
• When NOCDURNA competes against different mechanisms (for example, OAB therapy categories), payers compare:
  • clinical target patient phenotype,
  • expected treatment response,
  • discontinuation rates,
  • monitoring and adverse-event burden.

Market adoption pattern

• Adoption rises when prescribers can quickly connect symptoms to nocturnal polyuria and when payers accept the diagnostic rationale.

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What FDA regulatory events and post-marketing requirements affect NOCDURNA uptake and restrictions?

FDA label restrictions and safety communications influence prescriber willingness to start or continue treatment. For desmopressin products, key commercial constraints often include:

• warnings and monitoring expectations (notably serum sodium checks),
• patient contraindication language,
• risk mitigation messaging.

Commercial outcome

• Higher perceived risk increases PA usage and reduces conversion.
• Monitoring requirements can lengthen the time-to-therapy and reduce persistence.

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What commercial scale has NOCDURNA reached, and what is its revenue trajectory by phase (launch, growth, maturity, decline)?

Revenue trajectory framework for niche specialty urology products

1. Launch ramp
   • Uptake depends on payer coverage decisions and prescriber familiarity.
   • Early channel sales are influenced by PA approval rates and initial formulary positioning.
2. Growth to maturity
   • Growth typically slows as the market saturates with covered patients and as payers tighten criteria.
3. Maturity
   • Net sales are stable but face incremental pressure from:
     • generics or authorized generics,
     • competing branded formats,
     • heightened utilization management.
4. Decline
   • Decline accelerates around patent expiry or settlement-driven generic entry.

Bottom-line financial drivers

• Net sales are most sensitive to the number of covered lives and the share of eligible patients actually initiating therapy under payer policy.
• Price concessions can mask volume declines until the final exclusivity window.

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Key market scenarios: how net sales may evolve through exclusivity and generic entry

Scenario A: Exclusivity holds; payer access improves

• Net sales can remain steady or grow modestly as:
  • formulary placement deepens,
  • prescriber adoption broadens,
  • patient persistence stabilizes.

Scenario B: Exclusivity holds; payer access tightens

• Net sales plateau as:
  • PA approvals tighten,
  • QLs reduce titration behavior,
  • prescribers revert to low-cost alternatives.

Scenario C: Early exclusivity erosion or settlement triggers earlier generic entry

• Net sales step down with reduced demand and rapid substitution in covered members.

Scenario D: Strong settlement/no-entry terms delay competition

• Net sales stay elevated longer and then decline near the delayed-entry date rather than first expiry.

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Key Takeaways

• NOCDURNA’s financial trajectory is driven less by broad incidence and more by managed care access, PA/QL friction, and persistence among nocturnal polyuria patients.
• The exclusivity and Orange Book patent set determine generic substitution timing and whether net sales fall at patent expiry or later due to litigation settlements.
• Revenue durability is strongest when payer coverage stays preferred and when the patent estate blocks easy design-arounds for generic competitors.
• Competitive pressure accelerates when multiple low-cost alternatives can be routed through PBMs without heavy administrative barriers.

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FAQs

1) What typically happens to NOCDURNA net sales after the first major patent expiry date?
Net sales usually compress quickly as payer formularies and pharmacy routing shift toward lower-cost desmopressin alternatives, especially where PA and QL barriers are minimal.

2) Does NOCDURNA face higher utilization management than generic desmopressin products?
Branded desmopressin products commonly face tighter coverage criteria, including PA requirements and documentation thresholds, to justify premium pricing.

3) How do litigation settlements impact the launch timing of generics versus at-risk entry?
Settlements often delay launch dates for challenger generics, converting an “at-risk” entry into a scheduled delayed launch.

4) What patient monitoring requirements can influence prescriber adoption and persistence for desmopressin nocturia therapy?
Monitoring expectations (notably sodium monitoring) and contraindication language can reduce initiation and continuation in real-world settings, increasing discontinuation risk.

5) How do formularies and PBM contracts shape NOCDURNA profitability beyond list price?
Net sales depend on rebate structures, tier placement, and routing rules. Even with stable list pricing, net price can fall if competitors gain preferred placement or if contracts are renegotiated.

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References

1. FDA Orange Book (Desmopressin acetate NOCDURNA listings and patent/exclusivity status). U.S. Food and Drug Administration.
2. FDA prescribing information for NOCDURNA (desmopressin acetate): label, safety warnings, and administration guidance. U.S. Food and Drug Administration.
3. FDA drug approval and exclusivity framework resources. U.S. Food and Drug Administration.