DYMISTA Drug Patent Profile

Which patents cover Dymista, and when can generic versions of Dymista launch?

Dymista is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in twenty-seven countries.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dymista

A generic version of DYMISTA was approved as azelastine hydrochloride; fluticasone propionate by APOTEX on April 28^th, 2017.

Summary for DYMISTA

International Patents:	57
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	13
Patent Applications:	36
Drug Prices:	Drug price information for DYMISTA
Drug Sales Revenues:	Drug sales revenues for DYMISTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DYMISTA
What excipients (inactive ingredients) are in DYMISTA?	DYMISTA excipients list
DailyMed Link:	DYMISTA at DailyMed

See drug prices for DYMISTA

See drug sales revenues for DYMISTA

Recent Clinical Trials for DYMISTA

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

Sponsor	Phase
Humanis Saglık Anonim Sirketi	Phase 1
St. Paul's Sinus Centre	Phase 4
MEDA Pharma GmbH & Co. KG	Phase 4

See all DYMISTA clinical trials

Pharmacology for DYMISTA

Drug Class	Corticosteroid Histamine-1 Receptor Antagonist
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists

Paragraph IV (Patent) Challenges for DYMISTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYMISTA	Nasal Spray	azelastine hydrochloride; fluticasone propionate	137 mcg/50 mcg per spray	202236	1	2014-06-13

US Patents and Regulatory Information for DYMISTA

DYMISTA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,163,723*PED
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,168,620*PED				Y

Expired US Patents for DYMISTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	8,163,723*PED
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,901,585
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,259,428*PED

International Patents for DYMISTA

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	2072051
Portugal	2072051
Brazil	PI0312128	formulação farmacêutica compreendendo azelastina e éster de fluticasona
Australia	2009243420	Combination of azelastine and steroids
World Intellectual Property Organization (WIPO)	03105856

Supplementary Protection Certificates for DYMISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	PA2013023	Lithuania		PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731	1390033-7	Sweden		PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731	175 5006-2013	Slovakia		PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215

DYMISTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dymista

Introduction

Dymista, a nasal spray containing azelastine hydrochloride and fluticasone propionate, is a pivotal treatment for moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms. This article delves into the market dynamics and financial trajectory of Dymista, highlighting its import and export trends, clinical efficacy, and the financial performance of its manufacturer, Viatris.

Clinical Efficacy and Market Authorization

Dymista has been extensively studied and proven to be efficacious in reducing total nasal symptom scores (TNSS) and total ocular symptom scores in patients with SAR. The market authorization for Dymista was based on three pivotal, 2-week, randomized, multicentre, double-blind, placebo-controlled clinical studies. These studies demonstrated that Dymista provided a consistent benefit over placebo in reducing TNSS and other symptoms such as individual nasal and ocular symptoms, quality of life scores, and postnasal drip scores[4].

Global Import and Export Trends

The global market for Dymista involves a significant number of manufacturers, exporters, and importers. As of the data up to June 2024, the world imported 572 shipments of Dymista from March 2023 to February 2024, marking a 2% growth rate compared to the preceding twelve months. These imports were supplied by 45 exporters to 47 global buyers. Notably, in February 2024 alone, there were 36 Dymista shipments, indicating a year-on-year growth of -14% compared to February 2023 but a 64% sequential increase from January 2024[1].

Key Exporting and Importing Countries

India and the Netherlands are among the prominent countries involved in the export and import of Dymista. For instance, several shipments of Dymista were recorded from India to the Netherlands, with significant monetary values attached to these transactions. Other countries like the United Arab Emirates also feature in the import landscape of Dymista[1].

Financial Performance of Viatris

Viatris, the manufacturer of Dymista, has shown robust financial performance in recent quarters. In the third quarter of 2024, Viatris reported total revenues of $3.8 billion, with an operational revenue growth of approximately 3% on a divestiture-adjusted basis. The company generated $133 million in new product revenues, driven by products like Breyna™ and lisdexamfetamine, although Dymista's specific contribution is not detailed in these reports[2][5].

Revenue and Profitability

Viatris's financial strength is evident from its U.S. GAAP net earnings of $95 million and adjusted EBITDA of $1.3 billion, which saw a 4% increase on a divestiture-adjusted operational basis. The adjusted EPS grew by 6% to $0.75 per share. The company also demonstrated strong cash flow, with U.S. GAAP net cash provided by operating activities of $827 million and free cash flow of $866 million, excluding transaction costs related to divestitures[2][5].

Debt Repayment and Strategic Moves

Viatris has been proactive in managing its debt, repaying approximately $1.9 billion in the third quarter of 2024. The company aims to achieve its long-term gross leverage target of about 3.0x by the end of the year. Additionally, Viatris has entered into exclusive licensing agreements, such as the one for Sotagliflozin, to expand its innovative portfolio in cardiovascular diseases[2].

Market Impact and Patient Convenience

The availability of Dymista as a fixed-dose combination of azelastine hydrochloride and fluticasone propionate offers significant convenience to patients with moderate to severe SAR. This combination does not represent a greater degree of harm compared to monotherapy with either antihistamines or intranasal corticosteroids alone. The convenience of a single product for patients who require both types of medications enhances patient compliance and overall treatment outcomes[4].

Adverse Events and Safety Profile

Clinical studies have shown that Dymista is generally well-tolerated, with commonly observed adverse events being mild and reversible. These include epistaxis, dysgeusia, and headache. The safety profile of Dymista is consistent with the individual components, indicating no unexpected adverse outcomes from the combination therapy[4].

Future Outlook

Given the clinical efficacy and patient convenience of Dymista, it is likely to continue playing a significant role in the treatment of SAR. The ongoing financial strength of Viatris and its strategic moves to expand its product portfolio suggest a positive future outlook for the drug.

Market Growth Potential

The growing demand for effective treatments for allergic rhinitis, coupled with the convenience and efficacy of Dymista, positions it for continued market growth. As more patients seek combination therapies that offer comprehensive symptom relief, Dymista is poised to capture a larger share of the market.

Regulatory and Clinical Developments

Future regulatory approvals and clinical studies could further enhance the market position of Dymista. For instance, studies in pediatric populations or additional indications could expand its user base and reinforce its market presence[3].

Key Takeaways

• Clinical Efficacy: Dymista has been proven effective in reducing TNSS and other symptoms associated with SAR.
• Global Trade: Significant import and export activities of Dymista, with key countries like India and the Netherlands involved.
• Financial Performance: Viatris's robust financials, including revenue growth and strong cash flow.
• Patient Convenience: Dymista offers a convenient fixed-dose combination therapy.
• Safety Profile: Generally well-tolerated with mild and reversible adverse events.
• Future Outlook: Positive market growth potential driven by demand for effective SAR treatments.

FAQs

What is Dymista used for?

Dymista is used for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older.

Who manufactures Dymista?

Dymista is manufactured by Viatris.

What are the active ingredients in Dymista?

The active ingredients in Dymista are azelastine hydrochloride and fluticasone propionate.

What is the safety profile of Dymista?

Dymista is generally well-tolerated, with commonly observed adverse events being mild and reversible, such as epistaxis, dysgeusia, and headache.

How has the global trade of Dymista been trending?

The global trade of Dymista has shown a 2% growth rate from March 2023 to February 2024, with significant shipments from countries like India to the Netherlands.

Sources

1. Volza.com: Dymista Imports in World - Volza.com
2. Viatris Newsroom: Viatris Reports Third Quarter Financial Results for 2024
3. FDA: Dymista® (azelastine hydrochloride and fluticasone propionate) Statistical BPCA
4. Health Canada: Summary Basis of Decision for Dymista
5. PR Newswire: Viatris Reports Third Quarter Financial Results for 2024