TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for tetracycline hydrochloride and what is the scope of patent protection?

Tetracycline hydrochloride is the generic ingredient in fourteen branded drugs marketed by Avet, Bristol, Warner Chilcott, Pharmacia And Upjohn, Solvay, Wyeth Ayerst, Apothecon, Angus, Abbott, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Chartwell Tetra, Elkins Sinn, Esjay Pharma, Ferrante, Heather, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Valeant Pharm Intl, Watson Labs, Pfipharmecs, Schiff And Co, Shire, Lederle, Pfizer, Storz, Endo Operations, Alpharma Us Pharms, Proter, and Strides Pharma, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-nine drug master file entries for tetracycline hydrochloride. Eight suppliers are listed for this compound.

Summary for TETRACYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	14
Applicants:	39
NDAs:	53
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	227
What excipients (inactive ingredients) are in TETRACYCLINE HYDROCHLORIDE?	TETRACYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	TETRACYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TETRACYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Universidade Federal do Para	Phase 3

See all TETRACYCLINE HYDROCHLORIDE clinical trials

Pharmacology for TETRACYCLINE HYDROCHLORIDE

Drug Class

Tetracycline-class Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for TETRACYCLINE HYDROCHLORIDE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D06AA	Tetracycline and derivatives
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for TETRACYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	ROBITET	tetracycline hydrochloride	CAPSULE;ORAL	061734-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Strides Pharma	SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfipharmecs	TETRACYN	tetracycline hydrochloride	CAPSULE;ORAL	060082-004	Approved Prior to Jan 1, 1982		DISCN	No	No

TETRACYCLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tetracycline Hydrochloride

Introduction

Tetracycline hydrochloride, a broad-spectrum antibiotic, has been a staple in both human and veterinary medicine for decades. This article delves into the market dynamics and financial trajectory of tetracycline hydrochloride, highlighting its current status, future projections, and the factors influencing its market.

Global Market Size and Forecast

The global tetracycline hydrochloride market was valued at US$ 892.4 million in 2024 and is projected to reach US$ 1.23 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period[1].

Regional Market Analysis

Asia Pacific

The Asia Pacific region leads the market with a 45% share and is the fastest-growing region, with a CAGR of 6.2%. This growth is driven by increasing healthcare needs and the expanding veterinary sector in countries like China and India[1].

North America

In North America, the market size was valued at US$ 234.5 million in 2024 and is expected to reach US$ 312.4 million by 2030, growing at a CAGR of 4.9%. The United States is a significant contributor to this regional market[1].

Europe

Europe also holds a substantial share of the market, with countries like Germany, the UK, France, and Italy contributing to the regional growth. The European market is characterized by a strong pharmaceutical sector and stringent regulatory frameworks[3].

Market Segmentation

By Type

The market is segmented into pharmaceutical grade and veterinary grade. Pharmaceutical grade dominates with a 75% market share, while veterinary grade is growing at a rate of 7% annually[1].

By Application

Tetracycline hydrochloride is used in various applications, including human healthcare and veterinary medicine. Human healthcare accounts for 60% of the consumption, while veterinary applications saw a 20% increase in adoption in 2023[1].

Growth Drivers

Increasing Healthcare Needs

The growing demand for antibiotics in human healthcare, particularly in emerging economies, is a significant driver. Tetracycline hydrochloride is widely used to treat various bacterial infections, contributing to its market growth[1].

Veterinary Applications

The veterinary sector is another key driver, with tetracycline hydrochloride being used to treat bacterial infections in animals. The increase in veterinary applications has boosted the market significantly[1].

R&D Investments

The industry is focusing on developing improved formulations, with a 25% growth in R&D investments aimed at enhancing efficacy. This focus on innovation is expected to drive market growth in the coming years[1].

Challenges and Restraints

Antibiotic Resistance

One of the major challenges facing the tetracycline hydrochloride market is the increasing issue of antibiotic resistance. This has led to a need for more research and management measures to slow the development of bacterial resistance[3].

Regulatory Frameworks

Stringent regulatory frameworks, especially in regions like Europe and North America, can pose challenges for market growth. Compliance with these regulations is crucial for manufacturers[2].

Competitive Landscape

The market is competitive, with several key players involved in the production and distribution of tetracycline hydrochloride. Companies like LGM Pharm are prominent in this space, focusing on high-purity formulations and innovative products[1].

Financial Performance

Revenue and Sales

The revenue from tetracycline hydrochloride is expected to increase significantly over the forecast period, driven by growing demand and expanding applications. The market saw a substantial increase in revenue, with projections indicating continued growth[1].

Pricing Trends

Historically, there have been significant price increases for oral tetracyclines, such as doxycycline hyclate, which saw a mean cost increase from $7.16 to $139.89 between 2011 and 2013. These price fluctuations can impact market dynamics and consumer access to these medications[4].

Future Trends

Resistance Management

Future trends will include more research and management measures to slow the development of bacterial resistance to antibiotics like tetracycline hydrochloride. This will involve innovative formulations and customized treatment approaches[3].

Sustainability and Innovation

The market will also focus on sustainability and innovation, with an emphasis on developing high-purity tetracycline hydrochloride to meet changing medical and drug treatment needs[3].

Key Takeaways

• The global tetracycline hydrochloride market is projected to grow from US$ 892.4 million in 2024 to US$ 1.23 billion by 2030.
• Asia Pacific is the fastest-growing region, driven by increasing healthcare needs and veterinary applications.
• Pharmaceutical grade dominates the market, but veterinary grade is growing rapidly.
• Antibiotic resistance and regulatory frameworks are significant challenges.
• R&D investments are increasing, focusing on efficacy enhancement and innovative formulations.

FAQs

What is the current global market size of tetracycline hydrochloride?

The global tetracycline hydrochloride market size was valued at US$ 892.4 million in 2024[1].

What is the projected growth rate of the tetracycline hydrochloride market?

The market is projected to grow at a CAGR of 5.5% from 2024 to 2030[1].

Which region leads the tetracycline hydrochloride market?

The Asia Pacific region leads the market with a 45% share and is the fastest-growing region[1].

What are the main applications of tetracycline hydrochloride?

Tetracycline hydrochloride is used in human healthcare and veterinary medicine, with human healthcare accounting for 60% of consumption[1].

What are the major challenges facing the tetracycline hydrochloride market?

The major challenges include antibiotic resistance and stringent regulatory frameworks[3][2].

Sources

1. 24 Market Reports: Tetracycline Hydrochloride Market | Size, share, status 2024 forecast ...
2. University of Maryland, Baltimore: Tetracycline hydrochloride - University of Maryland, Baltimore
3. News Channel Nebraska: Global High Purity Tetracycline Hydrochloride Market Size 2024 ...
4. PubMed: Influence of Market Competition on Tetracycline Pricing and Impact ...
5. Market Research Intellect: Global Tetracycline HCL Market Size, Scope And Forecast Report