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Last Updated: December 22, 2024

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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When do Linagliptin And Metformin Hydrochloride patents expire, and when can generic versions of Linagliptin And Metformin Hydrochloride launch?

Linagliptin And Metformin Hydrochloride is a drug marketed by Sunshine and Zydus Pharms and is included in two NDAs.

The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Linagliptin And Metformin Hydrochloride

A generic version of LINAGLIPTIN AND METFORMIN HYDROCHLORIDE was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.

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Summary for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
US Patents:0
Applicants:2
NDAs:2
Clinical Trials: 61
DailyMed Link:LINAGLIPTIN AND METFORMIN HYDROCHLORIDE at DailyMed
Drug patent expirations by year for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Recent Clinical Trials for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

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

SponsorPhase
Medanta, The Medicity, IndiaN/A
Dong Wha Pharmaceutical Co. Ltd.Phase 1
The First Affiliated Hospital with Nanjing Medical UniversityN/A

See all LINAGLIPTIN AND METFORMIN HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-003 Aug 30, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208449-003 Mar 30, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-001 Aug 30, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-002 Aug 30, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Jentadueto linagliptin, metformin hydrochloride EMEA/H/C/002279
Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Authorised no no no 2012-07-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Linagliptin and Metformin Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Linagliptin and Metformin Hydrochloride tablets are a crucial combination therapy in the management of Type 2 Diabetes Mellitus (T2DM). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this market.

Market Drivers

Several factors are driving the growth of the Linagliptin and Metformin Hydrochloride tablets market:

Rising Prevalence of Diabetes

The global incidence of Type 2 diabetes is increasing, creating a significant demand for effective diabetes management solutions. This rise in prevalence is a major driver for the market, as more patients require treatments like Linagliptin and Metformin Hydrochloride[1][3].

Healthcare Sector Advancements

Advancements in the healthcare sector, including better diagnostic tools and treatment options, are enhancing the market for these tablets. The integration of combination therapies into standard treatment protocols is also boosting market growth[1].

Preference for Combination Therapies

Combination therapies like Linagliptin and Metformin Hydrochloride are gaining preference due to their ability to enhance patient adherence and improve glycemic control. This preference is driven by the convenience and efficacy of these combination drugs[1][4].

Market Restraints

Despite the growth drivers, there are several challenges that could impede the market expansion:

Price Sensitivity

Price sensitivity, particularly in emerging economies, is a significant restraint. Linagliptin, compared to other treatments like metformin and sulfonylureas, is more expensive, which can limit its adoption in cost-conscious markets[1][5].

Regulatory Hurdles

Stringent regulatory approval processes and potential side effects are other restraints. The need for rigorous clinical trials and regulatory approvals can slow down market entry and expansion[1].

Competitive Landscape

The competitive landscape in the diabetes treatment market is intense, with numerous existing and emerging treatments. Market saturation with existing diabetes medications can also impact the growth of Linagliptin and Metformin Hydrochloride tablets[1].

Market Opportunities

There are several opportunities that can be leveraged to further grow the market:

Competitive Landscape and Niche Identification

Identifying niches in the competitive landscape, particularly in pharmacies and clinics, can help in targeting specific patient populations more effectively. For instance, the potential for linagliptin and metformin in geriatric populations appreciating combination therapy is a significant opportunity[1].

Regulatory Changes

Key regulatory changes can impact new market entries for diabetes combination drugs. Staying abreast of these changes and adapting strategies accordingly can open up new opportunities for market growth[1].

Emerging Markets

The expansion of healthcare infrastructure in emerging nations presents a substantial opportunity for growth. Increasing access to healthcare and rising awareness of diabetes management in these regions can drive demand for Linagliptin and Metformin Hydrochloride tablets[3].

Financial Trajectory

The financial outlook for the Linagliptin and Metformin Hydrochloride market is promising:

Market Size and Growth

The Linagliptin market, which includes combination therapies with Metformin, was valued at USD 1.3 billion in 2023 and is expected to reach USD 3 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 11.7% from 2024 to 2031[3].

Revenue Drivers

The revenue growth is driven by the increasing global incidence of Type 2 diabetes, the need for effective oral hypoglycemic medications, and the positive safety profile and convenience of use of Linagliptin. Additionally, the increasing usage of combination medicines and the expansion of healthcare infrastructure in emerging nations are contributing to this growth[3].

Efficacy and Safety

Clinical trials and studies have demonstrated the efficacy and safety of Linagliptin and Metformin Hydrochloride:

Clinical Trials

Phase III trials have shown that the combination of Linagliptin and Metformin Hydrochloride results in significant reductions in A1C levels. For example, the placebo-corrected reduction in A1C was 1.3% and 1.7% for the combination arms of Linagliptin 2.5 mg bid plus Metformin 500 or 1000 mg bid, respectively[2].

Safety Profile

Linagliptin has a favorable safety profile, with adverse event rates comparable to placebo and low rates of hypoglycemia. This safety profile, combined with its efficacy, makes it a preferred option for both consumers and healthcare professionals[2][5].

Key Company Profiles

Several leading pharmaceutical companies are involved in the development and marketing of Linagliptin and Metformin Hydrochloride tablets:

Major Players

Companies such as Boehringer Ingelheim Pharmaceuticals, Inc., Abbott Laboratories, Alembic Pharmaceuticals Limited, and others are key players in this market. These companies are investing in research and development, strategic partnerships, and market expansion to capitalize on the growing demand for these tablets[1].

Market Penetration and Development

The market penetration and development strategies are crucial for the growth of this market:

Market Penetration

Current market penetration involves detailed data from key industry players, highlighting the existing market landscape and identifying areas for further penetration. This includes expanding into new geographic regions and targeting different demographics[1].

Market Development

Potential growth prospects in emerging markets and expansion opportunities in mature segments are being assessed. This involves launching new products, entering untapped geographic regions, and making strategic investments to drive market development[1].

Product Development and Innovation

Continuous innovation is essential for maintaining market competitiveness:

Upcoming Technologies

Research and development efforts are focused on upcoming technologies and notable advancements in product innovation. This includes developing new formulations and improving existing ones to enhance efficacy and safety[1].

Clinical Evidence

Mounting clinical evidence supporting the advantages of Linagliptin, including cardiovascular protection, is further enhancing its market attractiveness. This evidence is crucial for regulatory approvals and for convincing healthcare professionals and patients of the drug's benefits[3].

Key Takeaways

  • The market for Linagliptin and Metformin Hydrochloride tablets is driven by the rising prevalence of Type 2 diabetes and the preference for combination therapies.
  • The financial trajectory indicates significant growth, with the market expected to reach USD 3 billion by 2031.
  • Clinical trials have demonstrated the efficacy and safety of this combination therapy.
  • Key players are investing in research, development, and strategic partnerships to capitalize on market opportunities.
  • Regulatory changes and market penetration strategies are critical for further growth.

FAQs

Q: What are the primary active ingredients in Linagliptin and Metformin Hydrochloride tablets?

A: The primary active ingredients are Linagliptin, a dipeptidyl peptidase (DPP4) inhibitor, and Metformin Hydrochloride, a widely prescribed oral antidiabetic[4].

Q: What is the expected market size of the Linagliptin market by 2031?

A: The Linagliptin market is expected to reach USD 3 billion by 2031, growing at a CAGR of 11.7% from 2024 to 2031[3].

Q: What are the key factors driving the growth of the Linagliptin and Metformin Hydrochloride market?

A: The key factors include the rising prevalence of Type 2 diabetes, healthcare sector advancements, and the preference for combination therapies[1][3].

Q: What are the potential side effects and safety concerns associated with Linagliptin and Metformin Hydrochloride tablets?

A: The tablets have a favorable safety profile with adverse event rates comparable to placebo and low rates of hypoglycemia. However, potential side effects and regulatory hurdles are considerations[1][2].

Q: Which companies are major players in the Linagliptin and Metformin Hydrochloride market?

A: Major players include Boehringer Ingelheim Pharmaceuticals, Inc., Abbott Laboratories, Alembic Pharmaceuticals Limited, and others[1].

Sources

  1. 360iResearch: Linagliptin & Metformin Hydrochloride Tablets Market.
  2. Lilly Investor Relations: New Phase III Data and Pooled Analysis for Linagliptin Show Improved Glycemic Control.
  3. Market Research Intellect: Linagliptin Market Size and Projections.
  4. FDA: 201281Orig1s000 - Clinical Pharmacology Review.
  5. American Academy of Family Physicians: Linagliptin (Tradjenta) for the Treatment of Diabetes Mellitus.

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