Macrolide Antimicrobial Drug Class List

Drugs in Drug Class: Macrolide Antimicrobial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666-002	Jul 19, 2018	AB	RX	No	No
Aurobindo Pharma Ltd	AZITHROMYCIN	azithromycin	TABLET;ORAL	207398-001	Jul 5, 2018	AB	RX	No	No
Epic Pharma Llc	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	207531-001	Apr 9, 2018	AB	RX	No	No
Pliva	AZITHROMYCIN	azithromycin	TABLET;ORAL	065225-001	Nov 14, 2005	AB	RX	No	No
Sandoz	AZITHROMYCIN	azithromycin	TABLET;ORAL	065209-001	Nov 14, 2005	AB	RX	No	No
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes

Macrolide Antimicrobial Market Analysis and Financial Projection

The macrolide antimicrobial market is navigating a complex landscape shaped by evolving bacterial resistance, therapeutic innovation, and competitive patent strategies. Here's a detailed analysis:

Market Dynamics

Growth Projections

• The global macrolide antibiotics market was valued at $5.6 billion in 2022 and is projected to reach $7.0 billion by 2032 (CAGR: 2.3%)[1]. Alternative forecasts suggest higher growth, with estimates of $102.09 billion by 2029 (CAGR: 11.5% from 2024)[7], reflecting divergent scopes (e.g., inclusion of non-antibiotic macrolides).

Key Drivers

1. Rising Bacterial Infections:

   • Respiratory infections (e.g., community-acquired pneumonia, with 24.8 cases/10,000 adults in the U.S.[1]) and skin infections (e.g., MRSA cases up 33.7% in the UK)[7] are primary demand drivers.
   • Macrolides like azithromycin and clarithromycin remain first-line treatments due to safety and efficacy[3].

2. Antibiotic Resistance:

   • Resistance to older antibiotics has spurred demand for novel formulations. For example, synthetic macrolides like KU13 show efficacy against macrolide-resistant Mycobacterium strains[8].

3. Geographic Expansion:

   • Asia-Pacific is the fastest-growing region (CAGR: ~10.2%) due to increasing healthcare spending[6], while North America and Europe lead in innovation and adoption[12].

Challenges

• Generic competition post-patent expiration (e.g., azithromycin)[3].
• Limited activity against Gram-negative bacteria without structural modifications[5].

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Patent Landscape

Innovative Synthesis Methods

• Fully synthetic platforms enable the creation of 300+ novel macrolides, including solithromycin, with enhanced activity against resistant pathogens[2][5]. Key advances include replacing the C10–C13 macrolactone fragment to improve Gram-negative penetration[5].

Formulation Patents

• Non-aqueous azithromycin for veterinary use (US12005071B2) addresses stability and administration challenges in felines[9].
• Stabilization techniques for poly-ene macrolides (US7741338-B2) enhance shelf-life[11].

Therapeutic Diversification

• Dry eye treatment: Patent T 0070/10 covers tacrolimus (FK506) for improving tear film breakup time[13].
• Antiviral/anti-inflammatory applications: Macrolides like Mac5 show dual activity against rhinovirus and inflammation[10].

Competitive Strategies

• Novartis, Pfizer, and Dechra Pharmaceuticals lead in niche formulations and combination therapies[9][11].
• Emerging players (e.g., Gland Pharma) focus on generics, intensifying price competition[3].

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Future Trends

1. Combination Therapies: Synergistic use with other antibiotics to combat resistance[3][7].
2. Extended-Spectrum Macrolides: Targeting multi-drug-resistant Gram-negative pathogens via structural optimization[5][8].
3. Non-Antibiotic Applications: Expansion into autoimmune diseases (e.g., dry eye)[13] and inflammation[10].
4. Eco-Friendly Manufacturing: Sustainable production methods to align with regulatory pressures[7].

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Highlight

"A synthetic platform enables the creation of macrolides with clinically relevant activity against resistant bacteria, overcoming limitations of traditional semisynthesis."[2][5]

This dynamic landscape underscores macrolides' adaptability, driven by both clinical necessity and innovative R&D. Companies investing in next-generation formulations and non-traditional applications are poised to capitalize on emerging opportunities.

References

1. https://www.alliedmarketresearch.com/macrolide-antibiotics-market-A69591
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC6526944/
3. https://github.com/roehrtizonov/Market-Research-Report-List-1/blob/main/macrolide-drugs-market.md
4. https://www.futuremarketinsights.com/reports/macrolides-market
5. https://pubs.acs.org/doi/10.1021/acs.accounts.1c00020
6. https://www.skyquestt.com/report/macrolide-antibiotics-market
7. https://www.thebusinessresearchcompany.com/report/macrolide-antibiotics-global-market-report
8. https://www.science.org/doi/10.1126/sciadv.adt2352
9. https://www.pharmaceutical-technology.com/data-insights/dechra-pharmaceuticals-gets-grant-for-non-aqueous-composition-containing-azithromycin-for-felines/
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC5031920/
11. https://pubchem.ncbi.nlm.nih.gov/patent/US7741338
12. https://sites.google.com/view/pulsemarketreport/home/market-reports/north-america-macrolide-antibiotics-market-size-and-forecast
13. https://www.epo.org/en/boards-of-appeal/decisions/t100070eu1
14. https://www.openpr.com/news/3926418/comprehensive-macrolide-antibiotics-market-insights