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Drugs in ATC Class J05AF
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Drugs in ATC Class: J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
| Tradename | Generic Name |
|---|---|
| ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | abacavir sulfate; lamivudine; zidovudine |
| LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE | lamivudine; nevirapine; zidovudine |
| TRIZIVIR | abacavir sulfate; lamivudine; zidovudine |
| >Tradename | >Generic Name |
Showing 1 to 3 of 3 entries
J05AF Market Analysis and Financial Projection
The market dynamics and patent landscape for ATC Class J05AF (Nucleoside and Nucleotide Reverse Transcriptase Inhibitors, NRTIs) are shaped by evolving therapeutic demands, robust R&D activity, and intense competition between originator and generic manufacturers. Here's a detailed analysis:
Market Overview
The global NRTI market remains a critical component of antiviral therapy, with $11 billion in projected NRTI sales by 2028 (29% of the HIV therapeutics market)[13]. Key drivers include:
- Dominance of combination therapies: Single-tablet regimens (STR FDCs) like lamivudine/tenofovir disoproxil fumarate account for 37.2% market share[13], reducing pill burden and improving compliance.
- Expanding indications: Beyond HIV, NRTIs like tenofovir disoproxil fumarate (Viread®) are pivotal in hepatitis B treatment[1].
- Global access initiatives: Generics and bulk API suppliers (e.g., 89 vendors for tenofovir disoproxil fumarate[1]) facilitate cost-effective access in low-income regions.
Key Players and Competitive Landscape
| Major pharmaceutical companies drive innovation and market dominance: | Company | Notable Drugs | Strategic Focus |
|---|---|---|---|
| Gilead Sciences | Tenofovir disoproxil, Emtricitabine | Patent extensions, combination FDCs[1][4][13] | |
| ViiV Healthcare | Abacavir, Zidovudine | Portfolio diversification[4] | |
| Aurobindo Pharma | Generics (e.g., Tenofovir) | API manufacturing and ANDA filings[1][5] |
Other leaders include Merck & Co., Teva, and Cipla, focusing on cost-effective generics and novel delivery systems[4][13].
Patent Landscape and Litigation
- Expiring patents: Tenofovir disoproxil fumarate (Viread®) faces 14 NDAs and 16 generic filers with tentative approvals[1], signaling upcoming market fragmentation.
- Patent disputes: Paragraph IV challenges against Viread® tablets (150–300 mg) began as early as 2010[1], highlighting aggressive generic entry strategies.
- Innovation trends: Over 6,768 patent applications for tenofovir disoproxil fumarate[1] and active research on 4'-substituted nucleosides[3][8] reflect efforts to bypass existing patents.
Clinical and Regulatory Dynamics
- Dosing standards: Defined Daily Doses (DDDs) for J05AF drugs like tenofovir disoproxil (245 mg = 300 mg fumarate) guide prescribing and reimbursement[12].
- Pricing scrutiny: Canada’s PMPRB highlighted Viread®’s premium pricing ($15.13/tablet) compared to nucleoside analogs like Ziagen®[2].
- Clinical trials: Phase 3 studies by MRC/UVRI and Assistance Publique-Hôpitaux de Paris explore new indications and combo therapies[1][9].
Future Outlook
- Pipeline innovation: Next-gen NRTIs like tenofovir alafenamide (J05AF13)[12] aim to reduce toxicity while maintaining efficacy.
- Market consolidation: STR FDCs will dominate, with 5.3% CAGR projected for HIV therapeutics through 2028[13].
- Patent cliffs: Expiring patents for emtricitabine (10 US patents)[5] and tenofovir will accelerate generic competition, lowering prices globally.
"NRTIs remain the backbone of HIV treatment despite emerging interest in N(t)RTI-free regimens"[11].
Key Takeaways:
- STR FDCs and generics are reshaping market access and pricing.
- Patent litigation and regulatory reviews critically impact profitability.
- R&D focuses on reducing side effects and enhancing bioavailability.
FAQs:
- Which NRTI has the highest generic competition?
Tenofovir disoproxil fumarate, with 16 suppliers and tentative ANDA approvals[1]. - How do DDDs affect NRTI utilization?
Standardized DDDs (e.g., 245 mg tenofovir disoproxil[12]) streamline global prescribing and procurement. - What drives premium pricing for Viread®?
First-mover status as a nucleotide analog and clinical superiority in resistance profiles[2][12].
References
- https://www.drugpatentwatch.com/p/generic/tenofovir+disoproxil+fumarate
- https://www.pmprb-cepmb.gc.ca/view.asp?ccid=674
- https://patents.google.com/patent/US20180002366A1/en
- https://www.360iresearch.com/library/intelligence/nucleoside-reverse-transcriptase-inhibitors
- https://www.drugpatentwatch.com/p/generic/emtricitabine
- https://cris.unibo.it/bitstream/11585/907654/3/Comparison%20of%20drug%20prescribing%20before%20and%20during%20the%20COVID-19%20pandemic:%20A%20cross-national%20European%20study.pdf
- https://go.drugbank.com/drugs/DB00495
- https://patents.google.com/patent/WO2015148746A1/en
- https://www.frontiersin.org/articles/10.3389/fitd.2021.723991/full
- https://www.tprinternational.com/global-patent-filing/
- https://pubmed.ncbi.nlm.nih.gov/22149368/
- https://atcddd.fhi.no/atc_ddd_index/?code=J05AF&showdescription=yes
- https://www.businesswire.com/news/home/20231113902193/en/Global-HIV-Diagnostics-and-Therapeutics-Markets-Report-2023-2028-with-Competitive-Analysis-of-Medtronic-Abbott-Sanofi-Roche-Bio-Rad-Laboratories-and-Danaher---ResearchAndMarkets.com
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