Macrolide Drug Class List

Drugs in Drug Class: Macrolide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	AZITHROMYCIN	azithromycin	TABLET;ORAL	211792-001	Jan 28, 2020	AB	RX	No	No
Sandoz	AZITHROMYCIN	azithromycin	TABLET;ORAL	065212-001	Nov 14, 2005	AB	RX	No	No
Strides Pharma	AZITHROMYCIN	azithromycin	TABLET;ORAL	215773-001	Jul 12, 2022	AB	RX	No	No
Sunshine	AZITHROMYCIN	azithromycin	TABLET;ORAL	209045-001	Dec 7, 2018	AB	RX	No	No
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes

Macrolide Market Analysis and Financial Projection

The global macrolide antibiotics market is experiencing steady growth driven by rising bacterial infections and healthcare advancements, while facing challenges from antimicrobial resistance. Significant patent activity focuses on novel formulations and compounds to address evolving clinical needs.

Market Dynamics

Growth Drivers

• Rising Infection Rates: Respiratory tract infections (24.8 cases/10,000 adults in the U.S.[1]), skin infections, and STIs are key drivers. Macrolides like azithromycin dominate due to efficacy against Streptococcus pneumoniae and Haemophilus influenzae[11][13].
• Demand in Emerging Markets: Asia-Pacific leads growth (CAGR 2.8%[6]), fueled by population density and improving healthcare access. China and India account for 37% of global antibiotic use[16].
• Advantages of Oral Administration: Oral macrolides hold >50% market share due to cost-effectiveness and ease of use[1][6].

Market Segmentation

• By Drug: Azithromycin (50% revenue share[3]), clarithromycin, and erythromycin.
• By Indication: Respiratory infections lead (34% market share[13]), followed by STIs and skin infections.
• By Distribution: Drug stores dominate (50% revenue[1]), but online providers grow fastest (CAGR 3.1%[6]).

Projections: Conflicting estimates highlight methodological differences:

• Allied Market Research: $5.6B (2022) → $7B by 2032 (CAGR 2.3%)[1].
• Data Bridge: $70.6M (2023) → $187.7M by 2031 (CAGR 13%[3]).

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Patent Landscape

Key Innovations

• Sustained-Release Formulations: Patent US 6,440,458 covers amorphous-state macrolides (e.g., tacrolimus) for controlled delivery[2].
• Novel Compounds: EP3166934B1 discloses macrolides with modified lactone rings to bypass resistance mechanisms[12].
• Macrolones: Hybrid macrolide-fluoroquinolone agents show 8x higher efficacy than azithromycin against resistant strains[11].

Litigation and Generics

• Abbott’s clarithromycin patent (US 6,440,458) faced challenges over bioavailability claims, highlighting IP vulnerabilities as generics emerge[4].
• Post-Brexit SPC reforms streamline UK-wide marketing authorizations, affecting timelines for generic entry[14].

R&D Trends

• Synthetic Platforms: Fully synthetic routes enable >300 new macrolide candidates, including solithromycin[9].
• Resistance Mitigation: Focus on non-inducing erm gene inhibitors and bacteriostatic-to-bactericidal conversion at higher doses[11][9].

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Strategic Outlook

• Asia-Pacific Expansion: Companies target India and China with generics and partnerships leveraging low production costs[16].
• Pipeline Priorities: 63% of industry R&D focuses on overcoming macrolide-lincosamide-streptogramin B (MLS_B) resistance[11].
• Sustainability: Bio-based polymers and recyclable PET packaging gain traction in drug delivery systems[15].

“The convergence of synthetic chemistry and structural biology is unlocking macrolides’ full potential against multidrug-resistant pathogens.”
– PMC, 2024[9]

As patent cliffs loom (e.g., azithromycin’s 2025 expiry[10]), agile IP strategies and next-gen formulations will define competitive advantage in this $6–$9B sector[5][10].

References

1. https://www.alliedmarketresearch.com/macrolide-antibiotics-market-A69591
2. https://www.drugpatentwatch.com/p/patent/6440458
3. https://www.databridgemarketresearch.com/reports/global-macrolide-antibiotics-market
4. http://cafc.uscourts.gov/opinions-orders/05-1433.pdf
5. https://www.zionmarketresearch.com/report/macrolide-drugs-market
6. https://www.einpresswire.com/article/784633150/macrolide-antibiotics-market-sets-new-record-projected-at-usd-7-0-billion-by-2032-at-2-3-cagr-amr
7. https://drugrepocentral.scienceopen.com/hosted-document?doi=10.58647%2FDRUGREPO.24.2.0017
8. https://www.alliedmarketresearch.com/press-release/macrolide-antibiotics-market.html
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC6526944/
10. https://github.com/roehrtizonov/Market-Research-Report-List-1/blob/main/macrolide-drugs-market.md
11. https://journals.asm.org/doi/abs/10.1128/aac.00524-16
12. https://patents.google.com/patent/EP3166934B1/en
13. https://www.thebusinessresearchcompany.com/report/macrolide-antibiotics-global-market-report
14. https://ipi.academy/blog/details/267/navigating-the-evolving-pharma-patent-landscape-the-role-of-ip-strategy
15. https://www.businesswire.com/news/home/20250110674650/en/Medical-PET-Patent-Landscape-Report-2025-Covering-1408-Patents-Filed-from-2010-to-2024---ResearchAndMarkets.com
16. https://www.skyquestt.com/report/macrolide-antibiotics-market