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Last Updated: April 3, 2025

LINAGLIPTIN - Generic Drug Details


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What are the generic sources for linagliptin and what is the scope of patent protection?

Linagliptin is the generic ingredient in five branded drugs marketed by Invagen Pharms, Sunshine, Zydus Pharms, and Boehringer Ingelheim, and is included in eight NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Linagliptin has four hundred and sixty-two patent family members in forty-five countries.

There are nineteen drug master file entries for linagliptin. Three suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for LINAGLIPTIN
Recent Clinical Trials for LINAGLIPTIN

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

SponsorPhase
EMSPhase 3
Diabetes & Endocrinology FoundationN/A
Medanta, The Medicity, IndiaN/A

See all LINAGLIPTIN clinical trials

Generic filers with tentative approvals for LINAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free5MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free2.5MG; 1GTABLET;ORAL
⤷  Try for Free⤷  Try for Free2.5MG; 850MGTABLET;ORAL

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 LINAGLIPTIN
Medical Subject Heading (MeSH) Categories for LINAGLIPTIN
Paragraph IV (Patent) Challenges for LINAGLIPTIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRADJENTA Tablets linagliptin 5 mg 201280 11 2015-05-04

US Patents and Regulatory Information for LINAGLIPTIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 AB RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for LINAGLIPTIN

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try for Free ⤷  Try for Free
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries

EU/EMA Drug Approvals for LINAGLIPTIN

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Boehringer Ingelheim International GmbH Trajenta linagliptin EMEA/H/C/002110
Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Authorised no no no 2011-08-23
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

International Patents for LINAGLIPTIN

CountryPatent NumberTitleEstimated Expiration
China 105001222 New 8-(3-amino-piperidin-1-yl)-xanthine derivatives, preparing method and uses thereof as a pharmaceutic preparation ⤷  Try for Free
Colombia 6361917 ⤷  Try for Free
Eurasian Patent Organization 029039 СПОСОБ ПОЛУЧЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА С ИСПОЛЬЗОВАНИЕМ ХИРАЛЬНЫХ 8-(3-АМИНОПИПЕРИДИН-1-ИЛ)КСАНТИНОВ (METHOD FOR PRODUCING A MEDICAMENT USING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL)XANTHINES) ⤷  Try for Free
Norway 20071522 ⤷  Try for Free
Peru 20110666 COMPOSICIONES FARMACEUTICAS DE INHIBIDORES DE DPP IV ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Supplementary Protection Certificates for LINAGLIPTIN

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2187879 132017000050485 Italy ⤷  Try for Free PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
2187879 20/2017 Austria ⤷  Try for Free PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
1532149 91889 Luxembourg ⤷  Try for Free 91889, EXPIRES: 20260824
1532149 C01532149/01 Switzerland ⤷  Try for Free PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1084705 PA2014044 Lithuania ⤷  Try for Free PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory of Linagliptin

Introduction to Linagliptin

Linagliptin, marketed under the brand name Tradjenta, is a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes. It works by increasing the levels of incretin hormones, enhancing the release of insulin when glucose levels are elevated, and decreasing the release of glucagon by the liver.

Market Growth and Trends

The pharmaceutical grade linagliptin market has experienced rapid and substantial growth in recent years. Projections indicate a continued significant expansion from 2023 to 2031, driven by increasing demand for effective diabetes treatments and the rising prevalence of type 2 diabetes globally[1][4].

Segmentation and Market Size

The market is segmented based on type (purity ≥99%, purity <99%) and application (tablets, metformin tablets, metformin extended release tablets), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The purity ≥98% segment accounted for a noticeable share of the global linagliptin market in 2023 and is projected to experience significant growth in the near future[1][4].

Financial Performance

The financial trajectory of linagliptin is marked by steady growth. In Canada, for example, the spending on linagliptin has increased from $4 million in 2012 to $101 million in 2021. This trend reflects the increasing adoption of DPP-4 inhibitors in diabetes management[3].

Drivers of Growth

Several factors drive the growth of the linagliptin market:

  • Increasing Prevalence of Diabetes: The rising number of patients with type 2 diabetes globally creates a larger market for antidiabetic drugs like linagliptin[1][4].
  • Efficacy and Safety Profile: Clinical trials have demonstrated linagliptin's safety and efficacy, particularly its ability to reduce A1C levels with a low risk of hypoglycemia. This makes it a preferred option for many healthcare providers[5].
  • Convenience and Simplicity: Linagliptin is available in a once-daily tablet form, which can be taken with or without food, making it a convenient option for patients[2].

Challenges and Restraints

Despite the growth, the market faces several challenges:

  • Cost: Linagliptin is significantly more expensive than first-line therapies like metformin and sulfonylureas. A 30-day supply of linagliptin can cost around $250, which is a barrier for many patients[2].
  • Generic Competition: As patents for DPP-4 inhibitors expire, generic competition is expected to increase, potentially impacting the market share of branded products like linagliptin[3].
  • Alternative Therapies: The emergence of other antidiabetic drugs, such as GLP-1 receptor agonists, which have shown significant growth and additional indications beyond diabetes, poses a competitive threat to linagliptin[3].

Competitive Scenario

The linagliptin market is competitive, with several key players including Honor Lab, Morepen, Tapi Teva, EstechPharma, and others. These companies are focusing on strategy building and expanding their product portfolios to maintain market share[4].

Regional Analysis

The market is geographically diverse, with significant growth observed in regions like North America, Europe, and Asia-Pacific. Each region has its unique market dynamics, influenced by local healthcare policies, patient demographics, and economic factors[1][4].

Market Outlook and Forecast

The global linagliptin market is expected to continue its upward trend, driven by the increasing demand for antidiabetic medications and the expanding patient base. The market size is projected to grow significantly from 2023 to 2031, with a compound annual growth rate (CAGR) that reflects robust growth rates during the forecast period[1][4].

Key Players and Their Strategies

Key players in the linagliptin market are adopting various strategies to strengthen their market position:

  • Product Portfolio Expansion: Companies are focusing on expanding their product portfolios to include a range of antidiabetic medications.
  • Geographical Expansion: Players are looking to expand their presence in emerging markets where the demand for diabetes treatments is increasing.
  • Research and Development: Continuous investment in R&D to improve the efficacy and safety profile of linagliptin and to explore new indications[4].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the linagliptin market. Patients and healthcare providers prefer medications that are convenient, effective, and have a favorable safety profile. The once-daily dosing of linagliptin and its low risk of hypoglycemia make it a preferred choice for many[2][5].

Technological and Regulatory Trends

Technological advancements and regulatory changes also impact the market. For instance, the implementation of biosimilar switching policies in some regions has led to cost savings in the insulin market, which could influence the adoption of other antidiabetic drugs like linagliptin[3].

ESG and PESTEL Analysis

Environmental, Social, and Governance (ESG) factors, as well as Political, Economic, Social, Technological, Environmental, and Legal (PESTEL) analysis, are crucial in understanding the broader landscape of the linagliptin market. These factors can influence market dynamics, regulatory environments, and consumer behavior[4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the linagliptin market. While it has disrupted supply chains and affected healthcare services, it has also highlighted the importance of effective diabetes management, potentially increasing demand for antidiabetic medications[4].

Key Takeaways

  • The linagliptin market is experiencing significant growth driven by increasing demand for antidiabetic treatments.
  • The market is segmented by type and application, with the purity ≥98% segment and linagliptin tablets being key segments.
  • Despite high costs, linagliptin's efficacy and safety profile make it a preferred option.
  • Key players are focusing on product portfolio expansion and geographical growth.
  • Regulatory and technological trends, along with consumer behavior, play critical roles in shaping the market.

FAQs

Q: What is the primary use of linagliptin? A: Linagliptin is primarily used in the treatment of type 2 diabetes to help lower blood sugar levels.

Q: How does linagliptin compare to other DPP-4 inhibitors in terms of cost? A: Linagliptin is comparable in cost to other DPP-4 inhibitors but is significantly more expensive than first-line therapies like metformin and sulfonylureas[2].

Q: What are the key drivers of the linagliptin market? A: The key drivers include the increasing prevalence of diabetes, the efficacy and safety profile of linagliptin, and its convenience of use[1][4].

Q: How does linagliptin affect A1C levels? A: Clinical trials have shown that linagliptin can reduce A1C levels by approximately 1.2% when used as monotherapy and by 0.7% when added to metformin or metformin plus sulfonylurea[5].

Q: What are the potential challenges facing the linagliptin market? A: The market faces challenges such as high costs, generic competition, and the emergence of alternative therapies like GLP-1 receptor agonists[2][3].

Cited Sources

  1. Global Pharmaceutical Grade Linagliptin Market Size, Trends and ... - Market Research Intellect
  2. Linagliptin (Tradjenta) for the Treatment of Diabetes Mellitus - American Academy of Family Physicians
  3. Market Intelligence Report: Antidiabetic Drugs, 2012-2021 - Government of Canada
  4. Linagliptin Market Report 2024 (Global Edition) - Cognitive Market Research
  5. New Phase III Data and Pooled Analysis for Linagliptin Show ... - Eli Lilly and Company Investor Relations

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