MOMETASONE FUROATE - Generic Drug Details

What are the generic drug sources for mometasone furoate and what is the scope of patent protection?

Mometasone furoate is the generic ingredient in eight branded drugs marketed by Organon Llc, Organon, Chartwell Molecular, Cosette, Fougera Pharms, Glenmark Pharms, Sun Pharma Canada, Intersect Ent Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Aurobindo Pharma, Naspress, Perrigo Pharma Intl, and Glenmark Speclt, and is included in thirty-four NDAs. There are twenty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mometasone furoate has forty-seven patent family members in twelve countries.

There are twenty-seven drug master file entries for mometasone furoate. Twenty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for MOMETASONE FUROATE

International Patents:	47
US Patents:	23
Tradenames:	8
Applicants:	20
NDAs:	34
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	153
Patent Applications:	7,706
Drug Prices:	Drug price trends for MOMETASONE FUROATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOMETASONE FUROATE
What excipients (inactive ingredients) are in MOMETASONE FUROATE?	MOMETASONE FUROATE excipients list
DailyMed Link:	MOMETASONE FUROATE at DailyMed

See drug prices for MOMETASONE FUROATE

See drug sales revenues for MOMETASONE FUROATE

Recent Clinical Trials for MOMETASONE FUROATE

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

Sponsor	Phase
Huzhou Central Hospital	NA
Second Affiliated Hospital, School of Medicine, Zhejiang University	NA
First People's Hospital of Hangzhou	NA

See all MOMETASONE FUROATE clinical trials

Generic filers with tentative approvals for MOMETASONE FUROATE

Applicant	Application No.	Strength	Dosage Form
		0.05MG/SPRAY	SPRAY, METERED;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MOMETASONE FUROATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for MOMETASONE FUROATE

Anti-Allergic Agents

Anti-Inflammatory Agents

Dermatologic Agents

Anatomical Therapeutic Chemical (ATC) Classes for MOMETASONE FUROATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for MOMETASONE FUROATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASONEX	Nasal Spray	mometasone furoate	50 mcg/ Spray	020762	1	2009-08-07
ELOCON	Topical Solution (Lotion)	mometasone furoate	0.1%	019796	1	2004-06-10

US Patents and Regulatory Information for MOMETASONE FUROATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,765,686
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	10,232,152		Y
Glenmark Pharms Ltd	MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	090506-001	Aug 9, 2010		DISCN	No	No
Padagis Israel	MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	077180-001	Apr 6, 2005	AB	RX	No	Yes
Naspress	MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	211706-001	May 15, 2025		DISCN	No	No
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,016,443
Cosette	MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	077401-001	Jun 20, 2006	AB	RX	No	No

Expired US Patents for MOMETASONE FUROATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,951,133
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,662,141
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	6,068,832
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,951,131
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	9,585,681
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,713,255
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,951,130

International Patents for MOMETASONE FUROATE

Country	Patent Number	Title	Estimated Expiration
Canada	2518960	ADMINISTRATION DANS UN SINUS D'AGENTS THERAPEUTIQUES A LIBERATION PROLONGEE (SINUS DELIVERY OF SUSTAINED RELEASE THERAPEUTICS)
Australia	2010248992
China	101189016
South Korea	20080005939	DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS
Australia	2014236729
Canada	2732355	PROCEDES ET DISPOSITIFS POUR SERTIR DES DISPOSITIFS AUTO-DILATABLES (METHODS AND DEVICES FOR CRIMPING SELF-EXPANDING DEVICES)
Singapore	11201507476T	SYSTEMS, DEVICES, AND METHOD FOR TREATING A SINUS CONDITION

Supplementary Protection Certificates for MOMETASONE FUROATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410

Mometasone Furoate: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

How does the market for mometasone furoate move, product-by-product?

Mometasone furoate (MF) is a top-tier, long-established corticosteroid used across allergic and inflammatory indications, with demand anchored by (1) entrenched branded and generic intranasal therapies, (2) low incremental switching costs because many products are considered interchangeable by prescribers, and (3) ongoing share transfer to generics as patents and exclusivities expire. The market structure is typically: brand launches or line extensions in specific dosage forms, then sustained generic pressure once exclusivity ends, with pricing and margin compression followed by stabilization at low net price levels.

Key demand drivers

• Chronic seasonality and long-tail use: Allergic rhinitis and related inflammatory conditions create recurring seasonal demand plus physician-driven chronic control in a subset of patients.
• Multiple administration routes: Intranasal and topical formats diversify channels and mitigate single-form volatility.
• Formulation substitution: Patients and clinicians often treat within-class alternatives as therapeutically similar, shifting purchases toward the lowest net price.

Key supply and pricing mechanics

• Generic share growth: MF faces persistent generic entry in most geographies for several dosage forms. The economic pattern is faster generic penetration leading to reduced average selling prices (ASPs).
• Channel effects: Pharmacy benefit design and payer preferences often accelerate substitution to the lowest-cost equivalent.
• Line extension cadence: Companies maintain volume through reformulations, device changes, and combination products, but these typically do not fully reverse generic gravity.

What do the revenue and profitability trends show for mometasone furoate?

MF’s financial trajectory is best characterized as “volume-led, price-down” after generic entry. The market typically follows a two-phase pattern:

1) Pre-generic / exclusivity period

• Higher net price and margin profile.
• Stable market share due to established prescriber habits and patient familiarity.
• Limited competition from immediate equivalents.

2) Post-generic / broad substitution period

• Sharp decline in net price as branded share erodes.
• Gradual stabilization as the market becomes dominated by a small set of generic manufacturers and continued payer-driven substitution.
• Remaining profitability concentrates in efficient manufacturing, packaging, and distribution scale.

What to expect financially in most MF product lines

• Revenue: tends to hold up better than price due to recurring use, but growth is usually modest and driven by population and utilization rather than pricing power.
• Gross margin: compresses materially after widespread generic entry.
• Operating cash flow: often stays positive given low R&D intensity relative to novel drugs, though working capital and promotional spend can swing by cycle.

How do patent and exclusivity events typically reshape the curve?

MF products are subject to the usual interlocking ecosystem: composition-of-matter coverage, formulation/delivery patent families, and regulatory exclusivity in the form of Hatch-Waxman protections for U.S. generics (through Orange Book-listed exclusivities where applicable) and analogous protections elsewhere. Once exclusivity expires for a specific presentation (dose form, strength, device), the market usually shifts quickly to generics and resets pricing.

Practical dynamics

• Event-driven declines: Revenue drops cluster around the start of generic competition for each dosage form.
• Share redistribution: Generic share often consolidates among high-volume distributors and manufacturers with reliable supply and competitive pricing.
• Brand response: Brands typically reduce promotional spend post-loss of exclusivity and focus on remaining defensible niches (device differentiation, patient support programs, or combination products).

Where does the money concentrate: formulations and indications?

MF is sold in multiple dosage forms that affect reimbursement and payer behavior differently:

Common monetizable MF categories

• Intranasal corticosteroids: High-volume chronic/seasonal demand with strong formulary management.
• Topicals (dermatology): More fragmented geography and payer rules; often faster to genericize due to formulation similarity and easier substitution at the pharmacy counter.
• Combination products (where available): Can sustain revenue longer because switching costs rise, though these are usually smaller than pure MF segments.

Implication for financial trajectory

• Intranasal generally anchors revenue base due to persistent utilization.
• Topical often experiences sharper price competition but can maintain volume with adequate reimbursement.

How do payer and pharmacy dynamics affect net pricing?

Mometasone furoate’s pricing trajectory is tightly linked to formulary placement and pharmacy substitution:

• Formulary tiering: Once an MF product is relegated to a lower tier or replaced by a preferred equivalent, demand shifts quickly.
• PBM contracting: PBMs often drive net pricing down through mandatory rebates and competitive bidding.
• Therapeutic interchange: Clinicians and plans treat many intranasal corticosteroids as functionally substitutable, pushing MF toward lowest net cost.

Result: the market’s dominant financial feature is net price compression, with revenue largely supported by utilization.

What are the cost, manufacturing, and supply-chain realities?

MF is a mature molecule with a well-established manufacturing footprint. Financial outcomes tend to depend on:

• Scale manufacturing economics: cost per unit falls as volumes rise for generic producers.
• Quality systems and regulatory compliance: expensive but stable barriers once products are on the market.
• Distribution logistics: low complexity compared with biologics; supply chain disruptions typically cause temporary disruptions rather than lasting market structure shifts.

For investment and R&D planning, that means MF is generally not a margin story built on innovation; it is an execution story built on cost, supply reliability, and payer access.

What does the U.S. regulatory framework imply for competitive entry?

MF products in the U.S. sit within the Orange Book ecosystem and Hatch-Waxman pathway for generics. Competitive entry timing is controlled by the listed patents and exclusivities for the specific listed drug product (drug, strength, dosage form, and manufacturer). Once those protections end, generic entry becomes a deterministic factor for pricing pressure.

Practical consequence

• Pricing trajectories in most MF presentations are less sensitive to clinical differentiation and more sensitive to regulatory event windows for each product listing.

Source: FDA Orange Book for listed drug protections and FDA-reviewed generic pathways. [1]

---

Financial trajectory map (market-style model for MF)

Below is a structural view of what investors and business planners typically observe across MF dosage forms after exclusivity windows close.

Phase	Typical market state	Revenue trend	Net price trend	Competitive intensity
Exclusivity tail	Brand holds share; fewer close equivalents on preferred tiers	Stable to modest growth	Higher net price	Moderate
Generic entry	Multiple ANDA products launch; substitution accelerates	Slower growth or decline	Sharp decline	High
Post-entry stabilization	Market consolidates among efficient suppliers	Flat to modest growth	Low, stable	Medium-high
Line extension offset	Device/formulation/combination supports niche	Partial stabilization	Limited recovery	Medium

This pattern aligns with how genericized specialty primary-care products typically evolve, including those in the corticosteroid class within Allergic Rhinitis and dermatology.

---

What milestones determine forward-looking financial outcomes for MF?

Future financial trajectory is driven less by molecule novelty and more by “market plumbing” milestones:

• Loss and expiry of listed protections per specific MF presentation (strength, dosage form) in each geography.
• Generic launch execution (timing, supply continuity, lot acceptance, and wholesaler coverage).
• Formulary status changes in managed care (tier moves, step edits, preferred product lists).
• Pricing and rebate strategy as PBMs and purchasers renegotiate after generic penetration.

---

Key Takeaways

• Mometasone furoate’s market dynamics follow a mature specialty model: recurring utilization supports volume while generic substitution drives net price down.
• The financial trajectory is typically “volume-led, price-down,” with margins compressing after exclusivity losses per dosage form.
• Forward outcomes depend primarily on regulatory event timing by product listing and payer contracting behavior, not on clinical differentiation.
• The intranasal segment generally anchors revenue stability, while topical segments often face sharper price competition due to easier interchange and faster payer substitution.

---

FAQs

1) Is mometasone furoate primarily a growth or decline product?
Post-generic-entry, it behaves like a volume product with pricing pressure. Growth is usually modest and utilization-driven rather than price-led.

2) What most determines net revenue for mometasone furoate?
Net price after PBM rebates and payer preference rules, which are heavily influenced by generic entry and formulary tiering.

3) Does the same financial pattern apply across intranasal and topical MF?
The core “generic substitution pressure” is the same, but intranasal typically holds revenue more steadily while topical pricing often compresses faster.

4) How do patent expirations translate to market share changes?
Once the relevant protections end for a specific product listing, generic entry accelerates substitution and quickly shifts share toward the lowest net-cost equivalents.

5) What is the key business lever for companies with MF products?
Execution on supply reliability and cost competitiveness, paired with payer-access strategy to maintain formulary presence.

---

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA Approved Drug Products (Orange Book) Search. https://www.accessdata.fda.gov/scripts/cder/daf/