HABITROL Drug Patent Profile

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

Habitrol is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in HABITROL is nicotine. There are thirty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nicotine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Habitrol

A generic version of HABITROL was approved as nicotine by DIFGEN PHARMS on October 20^th, 1997.

Summary for HABITROL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	11
Patent Applications:	3,643
What excipients (inactive ingredients) are in HABITROL?	HABITROL excipients list
DailyMed Link:	HABITROL at DailyMed

Recent Clinical Trials for HABITROL

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

Sponsor	Phase
NYU Langone Health	Phase 1
University of Virginia	N/A
The Cleveland Clinic	Phase 1/Phase 2

See all HABITROL clinical trials

Pharmacology for HABITROL

Drug Class

Cholinergic Nicotinic Agonist

US Patents and Regulatory Information for HABITROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-004	Nov 12, 1999		OTC	Yes	No
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-005	Nov 12, 1999		OTC	Yes	No
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-006	Nov 12, 1999		OTC	Yes	Yes

Expired US Patents for HABITROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-006	Nov 12, 1999
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-006	Nov 12, 1999
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-004	Nov 12, 1999
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-005	Nov 12, 1999

International Patents for HABITROL

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

Country	Patent Number	Title	Estimated Expiration
Austria	143277
Canada	1283053	METHODE ET APPAREIL POUR AIDES A DIMINUER L'INCIDENCE DU TABAGISME (METHOD AND APPARATUS FOR AIDING IN THE REDUCTION OF INCIDENCE OF TOBACCO SMOKING)
Hong Kong	7794	TRANSCUTANEOUS APPLICATION OF NICOTINE
Mexico	9203535	METODO Y APARATO PARA AYUDAR A LA REDUCCION DE LA INCIDENCIA DE FUMAR TABACO.

Market Dynamics and Financial Trajectory for Habitrol

Introduction

Habitrol, a nicotine replacement therapy (NRT) product, has been a significant player in the market for those seeking to quit smoking. Acquired by Dr. Reddy's Laboratories in 2014, Habitrol has undergone various market and financial transformations. Here, we delve into the market dynamics and financial trajectory of Habitrol.

Market Overview of Nicotine Replacement Therapy

The nicotine replacement therapy market has seen robust growth in recent years. It is projected to grow from $2.99 billion in 2023 to $3.22 billion in 2024, and further to $4.10 billion by 2028, with a compound annual growth rate (CAGR) of 6.3%[4].

Product Segmentation

Habitrol falls under the category of NRT patches, which is one of the key product segments in the market. Other segments include gum, lozenges, inhalers, and sprays. The patch segment, in particular, has been a stable and reliable option for many users due to its ease of use and consistent nicotine delivery[4].

Distribution Channels

Habitrol is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. The diversification of distribution channels has helped in increasing accessibility and convenience for consumers, contributing to the product's market presence[4].

Acquisition and Integration by Dr. Reddy's Laboratories

Dr. Reddy's Laboratories acquired the Habitrol franchise in December 2014. This acquisition was part of the company's strategy to expand its portfolio in the over-the-counter (OTC) segment. The integration of Habitrol has contributed to Dr. Reddy's revenue growth, particularly in the proprietary products segment[2].

Financial Performance

Following the acquisition, Dr. Reddy's Laboratories saw an increase in revenue from its proprietary products segment, which includes Habitrol. For instance, in the financial year 2015, the segment revenue from proprietary products was ` 10.129 million, indicating a positive impact from the acquisition[2].

Revenue Contribution

Habitrol, as part of the proprietary products segment, has contributed to the overall revenue of Dr. Reddy's Laboratories. While the specific revenue figures for Habitrol are not detailed separately, the segment as a whole has shown growth. For example, in FY2021, the proprietary products segment revenue was part of the overall revenue increase to ` 189.722 billion[5].

Profitability

The profitability of Habitrol is reflected in the overall profitability of Dr. Reddy's Laboratories. The company's profit before taxes (PBT) increased significantly in FY2021 to ` 26.4 billion, which was 46% higher than the previous year. This increase can be attributed to various factors, including the performance of its OTC and proprietary products[5].

Market Drivers and Restraints

Drivers

• Emerging Markets: Growing healthcare access in emerging markets has driven the demand for NRT products like Habitrol[4].
• Technological Advancements: Digital health solutions and digital therapeutics integration have enhanced the effectiveness and appeal of NRT products[4].
• Government Initiatives: Public health campaigns and government initiatives to reduce smoking rates have boosted the demand for NRT products[4].

Restraints

• High Inflation: Economic instability and high inflation can impact consumer spending on non-essential health products, including NRTs[4].
• Competition: The NRT market is competitive, with various products available, which can affect market share and pricing strategies[4].

Digital Tools and Patient Education

Dr. Reddy's Laboratories has emphasized the use of digital tools and patient education to enhance adherence and effectiveness of Habitrol. This approach aligns with the broader trend of integrating digital health solutions in the NRT market. For example, Dr. Reddy’s plans to leverage its experience with Habitrol to address adherence issues in other therapeutic areas, such as diabetes and metabolic disorders[1].

Impact of COVID-19

The COVID-19 pandemic has underscored the importance of preventive healthcare measures, including smoking cessation. While the pandemic presented challenges, it also highlighted the need for accessible and effective NRT products like Habitrol. Dr. Reddy's Laboratories has been committed to ensuring the availability of such products during this period[5].

Future Outlook

The future outlook for Habitrol remains positive, driven by the growing demand for NRT products and the company's strategic initiatives. As the market continues to grow, Habitrol is expected to maintain its position as a reliable and effective NRT option.

"The increasing percentage of LPMs (Large Patient Populations) in pharmaceutical development has clear economic ramifications... For such products, the potential value created leads to an expected price and resulting profits that justify the research and development investments." - Source: The Economics of Drug Development[3]

Key Takeaways

• Market Growth: The NRT market, including Habitrol, is expected to grow significantly due to emerging markets, technological advancements, and government initiatives.
• Financial Performance: The acquisition of Habitrol by Dr. Reddy's Laboratories has contributed positively to the company's revenue and profitability.
• Digital Tools: The integration of digital tools and patient education has enhanced the effectiveness and adherence of Habitrol.
• Future Outlook: Habitrol is poised for continued growth as part of the expanding NRT market.

FAQs

What is Habitrol?

Habitrol is a nicotine replacement therapy (NRT) product in the form of a transdermal patch, designed to help individuals quit smoking.

Who acquired Habitrol?

Habitrol was acquired by Dr. Reddy's Laboratories in December 2014.

What are the key drivers of the NRT market?

Key drivers include emerging markets, technological advancements, government initiatives, and increased healthcare access.

How has the COVID-19 pandemic affected the NRT market?

The pandemic has highlighted the importance of preventive healthcare measures, including smoking cessation, and has underscored the need for accessible NRT products.

What is the projected growth of the NRT market?

The NRT market is projected to grow from $2.99 billion in 2023 to $4.10 billion by 2028, with a CAGR of 6.3%.

Sources

1. Pharmaceutical Commerce: Doubling Down on Drug Adherence
2. Dr. Reddy's Laboratories: Audited consolidated financial results of Dr. Reddy's Laboratories
3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market
4. The Business Research Company: Global Nicotine Replacement Therapy Market Report 2024
5. Annual Reports: Dr. Reddy's Laboratories Annual Report 2021