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Last Updated: December 22, 2024

TRANSDERM-NITRO Drug Patent Profile


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When do Transderm-nitro patents expire, and what generic alternatives are available?

Transderm-nitro is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in TRANSDERM-NITRO is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Transderm-nitro

A generic version of TRANSDERM-NITRO was approved as nitroglycerin by AM REGENT on May 24th, 1988.

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Summary for TRANSDERM-NITRO
Drug patent expirations by year for TRANSDERM-NITRO
Recent Clinical Trials for TRANSDERM-NITRO

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

SponsorPhase
Repurposed Therapeutics, Inc.Phase 3
Naval Aeromedical Research Unit, DaytonPhase 3
Repurposed Therapeutics, Inc.Phase 2/Phase 3

See all TRANSDERM-NITRO clinical trials

US Patents and Regulatory Information for TRANSDERM-NITRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 DISCN Yes 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

Expired US Patents for TRANSDERM-NITRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 4,812,313 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 4,812,313 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 4,849,226 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 4,954,344 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 4,812,313 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 4,849,226 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 4,812,313 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRANSDERM-NITRO

See the table below for patents covering TRANSDERM-NITRO around the world.

Country Patent Number Title Estimated Expiration
Spain 513357 ⤷  Subscribe
Germany 68927298 ⤷  Subscribe
European Patent Office 0505013 Dispositif pour régler la vitesse de rotation d'un engin de terrassement (Apparatus for controlling rotational speed of prime mover of a construction machine) ⤷  Subscribe
Denmark 82982 ⤷  Subscribe
Australia 545402 ⤷  Subscribe
Sweden 452403 BANDAGE FOR ADMINISTRERING AV LEKEMEDEL MED EN RESERVOAR SOM UTGORES AV ETT LEKEMEDEL I EN VETSKEFORMIG BERARE SAMT ETT GELBILDANDE EMNE ⤷  Subscribe
Ireland 52931 BANDAGE FOR ADMINISTERING BENEFICIAL DRUG ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

TRANSDERM-NITRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Transderm Nitro

Introduction to Transderm Nitro

Transderm Nitro, a transdermal therapeutic system containing nitroglycerin, is designed to prevent attacks of chest pain (angina) by providing continuous controlled release of nitroglycerin through intact skin[5].

Market Size and Growth

The transdermal drug delivery system market, which includes products like Transderm Nitro, is experiencing significant growth. In the U.S., this market was valued at USD 30.31 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 11.4% from 2023 to 2030, reaching USD 71.63 billion by 2030[1].

Key Drivers of Market Growth

Several factors are driving the growth of the transdermal drug delivery system market, including:

  • Increasing Demand for Painless Drug Delivery: The preference for non-invasive and painless drug administration is a major driver. Transdermal systems like Transderm Nitro offer ease of administration and low rejection rates among patients[1][3].
  • Rising Demand for Self-Administration: The trend towards self-administration of drugs is another significant factor. Transdermal patches allow patients to manage their medication independently, which is particularly beneficial for chronic conditions[1][3].
  • Technological Advancements: Ongoing technological advancements, such as the use of microneedles and smart patches, are enhancing the efficacy and patient compliance of transdermal drug delivery systems[1][3].

Application in Cardiovascular Diseases

Transderm Nitro is specifically used in the treatment of cardiovascular diseases, such as hypertension, congestive heart failures, and angina pectoris. The cardiovascular segment is anticipated to undergo maximum growth over the forecast period due to the increasing utilization of transdermal drug delivery systems in these treatments[1].

Clinical Efficacy

Studies have shown that nitroglycerin, the active ingredient in Transderm Nitro, is highly efficacious in treating cardiovascular conditions. For instance, nitroglycerin ointment has been shown to increase bone density and strength, although this is not its primary use. It has significant effects on vascular smooth muscle, leading to dilatation of peripheral arteries and veins, which reduces left ventricular end-diastolic pressure and pulmonary capillary wedge pressure[2][5].

Market Segmentation

The transdermal drug delivery system market is segmented by application, with the cardiovascular segment being one of the largest. Other segments include pain management, CNS, hormone, immunological, metabolic, and more. The pain management segment dominated the U.S. market with a share of 22.7% in 2022, but the cardiovascular segment is expected to grow significantly due to the increasing prevalence of cardiovascular disorders[1].

Competitive Landscape

The market for transdermal drug delivery systems is competitive, with several key players. Companies like Novartis AG, Johnson & Johnson, Boehringer Ingelheim GmbH, Viatris Inc., and 3M Company are prominent in this market. Strategic initiatives such as mergers and acquisitions, like Novartis AG's acquisition of Kedalion Therapeutics, are common among these players to strengthen their market positions[1].

Financial Outlook

The global transdermal patch market, which includes Transderm Nitro, is projected to surpass $15 billion by 2026. This growth is driven by the advantages of transdermal patches, including painless and non-invasive administration, ease of use, and prolonged drug activation[4].

Regional Trends

The U.S. market for transdermal drug delivery systems is particularly robust, driven by the high prevalence of chronic diseases and the focus on improving healthcare infrastructure post-pandemic. The U.S. government's increased focus on the healthcare sector is expected to further boost the market[1].

Challenges and Opportunities

While the market for transdermal drug delivery systems like Transderm Nitro is growing, there are challenges such as commercialization hurdles and the need for continuous innovation. However, the adoption of advanced technologies like 3D printing and smart patches presents significant opportunities for market growth[3].

Key Takeaways

  • The U.S. transdermal drug delivery system market is expected to grow at a CAGR of 11.4% from 2023 to 2030.
  • Transderm Nitro is a key product in the cardiovascular segment, which is expected to see significant growth.
  • Increasing demand for painless and self-administered drug delivery systems drives market growth.
  • Technological advancements and strategic initiatives by market players are crucial for market expansion.
  • The global transdermal patch market is projected to surpass $15 billion by 2026.

FAQs

Q: What is the primary use of Transderm Nitro? A: Transderm Nitro is used to prevent attacks of chest pain (angina) by providing continuous controlled release of nitroglycerin through intact skin.

Q: What is the expected growth rate of the U.S. transdermal drug delivery system market? A: The U.S. transdermal drug delivery system market is expected to grow at a CAGR of 11.4% from 2023 to 2030.

Q: Which segment dominates the U.S. transdermal drug delivery system market? A: The pain management segment dominated the U.S. market with a share of 22.7% in 2022, but the cardiovascular segment is expected to grow significantly.

Q: What are the key drivers of the transdermal drug delivery system market? A: The key drivers include increasing demand for painless drug delivery, rising demand for self-administration of drugs, and ongoing technological advancements.

Q: Who are some of the key players in the transdermal drug delivery system market? A: Key players include Novartis AG, Johnson & Johnson, Boehringer Ingelheim GmbH, Viatris Inc., and 3M Company.

Cited Sources

  1. Grand View Research: U.S. Transdermal Drug Delivery System Market Report, 2030.
  2. JAMA Network: Effect of Nitroglycerin Ointment on Bone Density and Strength in Postmenopausal Women.
  3. The Insight Partners: Transdermal Drug Delivery System Market Growth Scope 2030.
  4. Markets Business Insider: Transdermal Patch Market Study 2020-2026 - Global Market Projected to Surpass $15 Billion by 2026.
  5. RxList: Transderm Nitro (Nitroglycerin): Side Effects, Uses, Dosage.

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