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Last Updated: March 27, 2026

METHACYCLINE HYDROCHLORIDE - Generic Drug Details


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

Methacycline hydrochloride is the generic ingredient in one branded drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for methacycline hydrochloride.

Summary for METHACYCLINE HYDROCHLORIDE
Recent Clinical Trials for METHACYCLINE HYDROCHLORIDE

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

SponsorPhase
University of LouisvilleEarly Phase 1
James Graham Brown Cancer CenterEarly Phase 1
Julio RamirezEarly Phase 1

See all METHACYCLINE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for METHACYCLINE HYDROCHLORIDE

US Patents and Regulatory Information for METHACYCLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medpointe Pharm Hlc RONDOMYCIN methacycline hydrochloride SYRUP;ORAL 060641-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Medpointe Pharm Hlc RONDOMYCIN methacycline hydrochloride CAPSULE;ORAL 060641-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Medpointe Pharm Hlc RONDOMYCIN methacycline hydrochloride CAPSULE;ORAL 060641-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Methacycline Hydrochloride

Last updated: February 19, 2026

What is the current market landscape for Methacycline Hydrochloride?

Methacycline hydrochloride is a semi-synthetic tetracycline antibiotic used primarily to treat various bacterial infections. It is part of the broader antimicrobial market, which experienced growth driven by increasing bacterial resistance and rising disease prevalence.

Market size estimations for methacycline are limited due to its relatively niche status compared to other tetracyclines like doxycycline or tetracycline. Its primary markets include Asia, Africa, and parts of Europe, where it remains in use for urinary and respiratory infections. The global antibiotics market was valued at approximately USD 55.8 billion in 2021, growing at a compound annual growth rate (CAGR) of 3.8% through 2028 (Grand View Research, 2022). However, methacycline constitutes a small segment within this market.

How do regulatory policies impact the market?

Regulatory approvals focus on safety, efficacy, and manufacturing standards. Many regions have tightened antibiotic registrations, leading to a decline in older antibiotics in favor of novel agents. Withdrawals or restrictions have occurred in some markets due to resistance concerns or safety issues, but methacycline remains approved in some countries, primarily for veterinary use or specific medical indications.

The wave of antimicrobial stewardship policies reduces market growth potential for existing antibiotics. The US FDA and EMA have prioritized new antibiotics, which limits the growth of older drugs like methacycline unless manufacturers seek new indications or formulations.

What factors are influencing market demand?

  • Antibiotic resistance: Increasing bacterial resistance diminishes effectiveness, leading to decreased prescription rates for older antibiotics such as methacycline.
  • Infection prevalence: Rising cases of respiratory, urinary, and skin infections sustain demand in regions with limited access to newer antibiotics.
  • Prescribing practices: Preference shifts toward broad-spectrum or newer antibiotics in developed markets impact usage.
  • Veterinary applications: Methacycline's application in veterinary medicine sustains demand in agriculture, especially in countries with high livestock populations.

What is the competitive landscape?

The market features a handful of producers primarily based in India, China, and Europe. Major generic manufacturers include Aurobindo Pharma, Astellas Pharma, and Teva Pharmaceutical Industries. Patent exclusivity is largely expired for methacycline, leading to widespread generic availability.

Competition is characterized by price pressure, with average global prices declining over the last decade. A typical 100 mg capsule costs USD 0.10-0.20 in bulk, depending on region and purchase volume.

What are the financial trends shaping the outlook?

  • Pricing erosion: The entry of generics has driven prices downward. For example, a comparison shows a 35% decline in wholesale prices from 2015 to 2022.
  • Revenue stagnation: Due to reduced demand and price declines, revenues for key manufacturers have plateaued. Companies focusing on methacycline have shifted toward niche markets or veterinary applications.
  • Investments in R&D: Limited, given the age of the molecule and regulatory challenges in developing new formulations or indications.

What future projections are feasible?

The overall antibiotics market is expected to grow modestly, with a CAGR of 3.8% to 2028. Methacycline's segment remains small but stable in developing regions. Growth could be supported by:

  • Expanded veterinary usage.
  • Reintroduction in niche indications with reformulation.
  • Markets where resistance to newer antibiotics accelerates reliance on older agents.

Global sales of methacycline are estimated at USD 50-70 million annually, with no significant new market entrants expected in the near term.

Summary table: Key market data

Parameter Estimate / Data Point Source
Global antibiotics market value (2021) USD 55.8 billion Grand View Research (2022)
CAGR of antibiotics market (2022-2028) 3.8% Grand View Research (2022)
Price per 100 mg capsule (2015) USD 0.31 Industry sources
Price per 100 mg capsule (2022) USD 0.20 Industry sources
Estimated annual sales (global) USD 50-70 million Industry estimates

Key takeaways

  • Methacycline hydrochloride remains in niche use, mainly in developing markets or veterinary sectors.
  • Market demand is declining in human medicine due to resistance and safety concerns.
  • Price pressure from generics limits revenue potential.
  • Regulatory shifts favor newer antibiotics, constraining growth.
  • Future opportunities depend on veterinary applications or niche indications.

FAQs

1. Why is methacycline sales declining?
Resistance to tetracyclines and regulatory restrictions reduce prescription rates, leading to decreased sales.

2. Are there patents preventing methacycline's market expansion?
No; patents have expired in most regions, resulting in generic competition and price erosion.

3. Is methacycline used in veterinary medicine?
Yes; it remains in use for livestock and companion animals, maintaining demand in that sector.

4. What are the main competitors to methacycline?
Other tetracyclines like doxycycline and minocycline, along with newer class antibiotics, dominate the market.

5. What developments could revive methacycline's market?
Reformulation for new indications or resistant bacterial strains, or regulatory approval for niche uses.


References

[1] Grand View Research. (2022). Antibiotics Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/antibiotics-market

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