You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

DECLOMYCIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Declomycin patents expire, and what generic alternatives are available?

Declomycin is a drug marketed by Lederle and Corepharma and is included in three NDAs.

The generic ingredient in DECLOMYCIN is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DECLOMYCIN?
  • What are the global sales for DECLOMYCIN?
  • What is Average Wholesale Price for DECLOMYCIN?
Drug patent expirations by year for DECLOMYCIN
Drug Prices for DECLOMYCIN

See drug prices for DECLOMYCIN

Recent Clinical Trials for DECLOMYCIN

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

SponsorPhase
Massachusetts General HospitalPhase 1

See all DECLOMYCIN clinical trials

US Patents and Regulatory Information for DECLOMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle DECLOMYCIN demeclocycline hydrochloride CAPSULE;ORAL 050262-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Corepharma DECLOMYCIN demeclocycline hydrochloride TABLET;ORAL 050261-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lederle DECLOMYCIN demeclocycline hydrochloride SYRUP;ORAL 050257-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Corepharma DECLOMYCIN demeclocycline hydrochloride TABLET;ORAL 050261-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Corepharma DECLOMYCIN demeclocycline hydrochloride TABLET;ORAL 050261-003 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 DECLOMYCIN

Last updated: February 9, 2026

Overview
Declomycin (demeclocycline) is an antibiotic in the tetracycline class, primarily used for bacterial infections and off-label treatment of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). Its market presence has declined due to the advent of newer antibiotics and the decline in tetracycline-class drugs' popularity. Currently, Declomycin remains a niche pharmaceutical with limited commercial activity.


Market Size and Demand Analysis

Parameter Data/Status
Global antibiotic market (2022) $56 billion (source: Grand View Research)
Tetracycline antibiotic sales (2022) Estimated below $500 million, accounting for less than 1% of total antibiotics sales
Declomycin-specific sales (Est.) Small, primarily off-patent, limited to compounding and niche uses
Main indications Bacterial infections, SIADH (off-label)
Market trends Declining due to resistance, safety concerns, and competition from newer antibiotics

Key Points:

  • Declomycin’s role is confined mainly to niche segments; it does not command significant market share.
  • The antibiotic sector is mature, with a consolidation trend favoring newer molecules.
  • Off-label uses for SIADH are growing but still contribute minimally to overall sales.

Competitive Landscape

Competitors Products Market share estimate
Doxycycline, tetracycline products Doxycycline (Vibramycin), tetracycline formulations Dominant in tetracycline class
Fluoroquinolones Ciprofloxacin, levofloxacin Increasing market share
Macrolides Azithromycin, clarithromycin Growing popularity in respiratory infections

Analysis:
Declomycin faces stiff competition from more modern tetracyclines like doxycycline, which has prolonged half-life, less resistance, and fewer adverse effects. Newer classes such as fluoroquinolones and macrolides dominate broad-spectrum antibiotic markets.


Regulatory and Patent Status

Aspect Details
Patent exclusivity (original) Expired in the 1970s for Declomycin
Current patent status Off-patent globally
Regulatory approval (FDA, EMA) Approved; no recent new-drug approvals
Manufacturing landscape Generic producers dominate

Implication:
Patent expiration limits pricing power and incentivizes generic manufacturing, leading to reduced revenues.


Market Entry Barriers and Opportunities

Barrier/Opportunity Details
Entry barriers High due to dominant generics, low R&D incentives for reformulation
Opportunities Niche indications, drug repurposing, formulations for resistant strains
Off-label potential Limited growth due to regulatory and safety concerns

Conclusion:
Market dynamics favor generic diffusion with minimal growth prospects for Declomycin. Opportunities exist in niche indications but are limited in scope.


Financial Trajectory Outlook

Year Anticipated Revenue (USD) Key Factors
2023–2025 <$10 million annually Sustained but declining demand, generic focus
2026–2030 Stabilization at low levels (~$5 million) Limited new indications, competitive pressures
Post-2030 Potential further decline Off-patent status, market saturation

Factors Influencing Future Revenue:

  • Emergence of resistance may restrict use in certain bacterial infections.
  • Increased off-label use for SIADH remains limited due to safety concerns.
  • The trend toward newer, safer antibiotics could further suppress Declomycin sales.

Conclusion

Declomycin’s market is shrinking. It retains minimal revenue primarily from existing generic formulations. Its opportunities for growth are limited by high competition, safety profile concerns, and the low barrier to entry for generics. The drug’s financial trajectory indicates continued decline unless a new therapeutic application or formulation emerges.


Key Takeaways

  • Declomycin has a constrained market with limited growth prospects.
  • Dominated by generic competitors, with no recent patent protections.
  • Future revenues are expected to decline or remain minimal beyond 2025.
  • Niche uses like SIADH offer little upside due to safety and regulatory limitations.
  • Market forces favor newer antibiotics with better safety profiles.

FAQs

  1. What are the primary competitors to Declomycin?
    Main competitors include doxycycline and other tetracycline antibiotics, along with fluoroquinolones and macrolides.

  2. Can Declomycin be repurposed for new indications?
    Potential exists in niche areas, but safety concerns and resistance issues limit applicability.

  3. When did Declomycin lose patent protection?
    The original patent expired in the 1970s, leading to widespread generic production.

  4. What are the safety concerns with Declomycin?
    It is associated with photosensitivity, nephrotoxicity, and increased resistance, which limit off-label uses.

  5. Is there any pipeline development for Declomycin?
    Current activity is minimal; no significant pipeline development is publicly known.


References

  1. Grand View Research. "Antibiotics Market Size & Share." 2022.
  2. U.S. Food & Drug Administration. "Drug Approvals and Regulatory History."
  3. Company filings and patents database.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.