ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Drug Patent Profile

Which patents cover Allegra-d 12 Hour Allergy And Congestion, and when can generic versions of Allegra-d 12 Hour Allergy And Congestion launch?

Allegra-d 12 Hour Allergy And Congestion is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Allegra-d 12 Hour Allergy And Congestion

A generic version of ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION was approved as fexofenadine hydrochloride; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on June 22^nd, 2011.

Summary for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	69
DailyMed Link:	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION at DailyMed

Pharmacology for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011		OTC	Yes	Yes

Expired US Patents for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,113,942*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	7,138,524*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	5,578,610*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,399,632*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,187,791*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,039,974
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,037,353*PED

International Patents for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

See the table below for patents covering ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	693892
European Patent Office	0998272	COMPOSITION PHARMACEUTIQUE ASSOCIANT PIPERIDINO-ALCANOL ET DECONGESTIONNANT (PHARMACEUTICAL COMPOSITION FOR COMBINATION OF PIPERIDINOALKANOL-DECONGESTANT)
Portugal	812195
Spain	2176329
Germany	3005948
Canada	2585705	METHODES POUR PREPARER DES FORMES ANHYDRES ET HYDRATEES DE DERIVES ANTIHISTAMINIQUES DE LA PIPERIDINE; LEURS FORMES POLYMORPHES ET PSEUDOMORPHES (PROCESSES FOR PREPARING ANHYDROUS AND HYDRATE FORMS OF ANTIHISTAMINIC PIPERIDINE DERIVATIVES, POLYMORPHS AND PSEUDOMORPHS THEREOF)
China	1090935

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Allegra-D 12 Hour Allergy and Congestion

Introduction

Allegra-D 12 Hour Allergy and Congestion Extended-Release Tablets are a widely recognized medication for alleviating allergy and congestion symptoms. This article delves into the market dynamics and financial trajectory of this drug, highlighting key aspects such as market competition, financial performance, and strategic moves by major players.

Market Overview

The allergy and congestion relief market is highly competitive, with several brands and generic alternatives vying for market share. Allegra-D, with its active ingredients fexofenadine HCl and pseudoephedrine HCl, is a significant player in this segment.

Product Profile

Allegra-D 12 Hour Tablets are formulated to provide relief from nasal congestion, sinus pressure, sneezing, itchy eyes, itchy nose, and itchy throat. The product contains pseudoephedrine, a clinically proven decongestant, and fexofenadine, an antihistamine, making it effective for both indoor and outdoor allergies as well as temporary relief from the common cold and hay fever[3][4].

Market Competition

The market for allergy and congestion relief medications is crowded, with both branded and generic options available. Dr. Reddy's Laboratories, for instance, launched a generic version of Allegra-D 12 Hour Tablets in the U.S. market, which has been approved by the U.S. Food and Drug Administration (USFDA). This move expanded the availability of affordable alternatives to consumers, increasing competition in the market[1][5].

Financial Performance

The financial performance of Allegra-D and its generic equivalents is substantial. According to IRi data, the brand and generic versions of Allegra-D 12 HR Allergy and Congestion Extended-Release Tablets had U.S. sales of approximately $44 million for the twelve months ending in May 2019. This figure indicates a significant market presence and revenue generation for the product[1][5].

Strategic Moves by Dr. Reddy's

Dr. Reddy's Laboratories has been proactive in expanding its pseudoephedrine-based product offerings. The launch of their generic version of Allegra-D 12 Hour Tablets was timed to coincide with the peak cough, cold, and allergy season, maximizing market impact. This strategy reflects the company's commitment to providing high-quality, affordable alternatives to consumers, thereby increasing their market share[1].

Impact on Dr. Reddy's Financials

The launch of the generic Allegra-D by Dr. Reddy's has had a positive impact on the company's financials. While the specific financial gains from this product are not isolated in the company's overall financial reports, the expansion of their OTC portfolio has contributed to their revenue growth. The company's focus on affordable generics aligns with consumer demand for cost-effective healthcare solutions, which is likely to continue driving their financial performance[1][5].

Sanofi's Position in the Market

Sanofi, the original manufacturer of Allegra-D, continues to be a major player in the pharmaceutical market, although the specific financial impact of Allegra-D on Sanofi's overall performance is not as prominently highlighted as other products like Dupixent. Sanofi's financial reports show significant growth in other segments, such as Specialty Care and Vaccines, but the Consumer Healthcare (CHC) segment, which includes Allegra-D, also saw growth, albeit at a lower scale[2].

Consumer Preferences and Market Trends

Consumer preferences for non-drowsy, effective, and affordable allergy relief medications drive the demand for products like Allegra-D. The market trend favors products that offer multi-symptom relief, and Allegra-D's formulation of an antihistamine plus a decongestant makes it a preferred choice among consumers. This trend is expected to continue, with generic alternatives further increasing accessibility and affordability[3][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceutical products. The approval by the USFDA for Dr. Reddy's generic version of Allegra-D 12 Hour Tablets is a significant factor in its market entry and acceptance. Compliance with regulatory standards ensures the safety and efficacy of the product, which is essential for consumer trust and market success[1].

Future Outlook

The future outlook for Allegra-D and its generic equivalents appears positive. With increasing demand for over-the-counter (OTC) medications and a growing preference for affordable generics, companies like Dr. Reddy's are well-positioned to capture a larger market share. The strategic focus on expanding OTC portfolios and investing in research and development to improve product offerings will continue to drive growth in this segment[1][2].

Key Takeaways

• Market Competition: The allergy and congestion relief market is highly competitive, with both branded and generic options available.
• Financial Performance: Allegra-D and its generic versions generate significant revenue, with U.S. sales of approximately $44 million in the twelve months ending in May 2019.
• Strategic Moves: Dr. Reddy's launch of a generic version of Allegra-D 12 Hour Tablets has expanded affordable alternatives in the market.
• Consumer Preferences: Non-drowsy, effective, and affordable medications are in high demand, favoring products like Allegra-D.
• Regulatory Environment: USFDA approval is crucial for market entry and acceptance of generic versions.

FAQs

Q: What are the active ingredients in Allegra-D 12 Hour Tablets? A: The active ingredients are fexofenadine HCl and pseudoephedrine HCl[3][4].

Q: Who launched the generic version of Allegra-D 12 Hour Tablets in the U.S. market? A: Dr. Reddy's Laboratories launched the generic version, which was approved by the USFDA[1][5].

Q: What is the approximate U.S. sales figure for Allegra-D 12 HR Allergy and Congestion Extended-Release Tablets? A: The U.S. sales figure is approximately $44 million for the twelve months ending in May 2019[1][5].

Q: What is the significance of pseudoephedrine in Allegra-D? A: Pseudoephedrine is a clinically proven decongestant that helps reduce swelling of nasal passages and ease sinus pressure caused by allergies[3][4].

Q: Is Allegra-D available in different formulations? A: Yes, Allegra-D is available in both 12-hour and 24-hour formulations[3][4].

Sources

1. Dr. Reddy's Laboratories Ltd. - "Dr. Reddy's announces the launch of over-the-counter, store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets in the U.S. market"[1].
2. Sanofi - "Press Release Q4 2023 English"[2].
3. Allegra - "Allegra-D ® Allergy & Congestion 12 Hour Tablets"[3].
4. Allegra - "Allegra-D ® Allergy & Congestion 12 Hour Tablets"[4].
5. Financial Express - "Dr Reddy's $44 million-clocking drug Allegra launches in US market"[5].