Aromatic Amino Acid Drug Class List

Drugs in Drug Class: Aromatic Amino Acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	210341-001	Jun 5, 2019	AB	RX	No	No
Ascent Pharms Inc	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	218939-003	Jan 14, 2025	AB	RX	No	No
Dr Reddys Labs Sa	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	073618-001	Aug 28, 1992	AB	RX	No	No
Norvium Bioscience	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	090324-002	Sep 28, 2009	AB	RX	No	No
Rubicon	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	217482-001	Jun 4, 2024	AB	RX	No	No
Sciegen Pharms Inc	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	214092-003	May 7, 2021	AB	RX	No	No
Sun Pharm Inds	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	077828-002	Aug 23, 2007	AB	RX	No	No

Aromatic Amino Acid Market Analysis and Financial Projection

The market for drugs targeting aromatic amino acids (AAAs) — phenylalanine, tyrosine, tryptophan, and histidine — is expanding rapidly due to their critical role in treating metabolic disorders, cancer, and neurodegenerative diseases. Below is an analysis of the market dynamics and patent landscape shaping this sector.

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Market Dynamics

Growth Drivers

• Rising Demand for Metabolic Disorder Treatments:
  The global amino acid metabolism disorders treatment market (e.g., phenylketonuria, maple syrup urine disease) is projected to grow from $630.9 million in 2021 to $961.8 million by 2031 (CAGR 4.3%)[2]. Growth is driven by increased R&D, novel therapies like enzyme replacements, and improved diagnostics.
• Oncology Applications:
  HER2-targeted biologics, which rely on tyrosine-rich antibody designs, dominate oncology patents. Roche leads with 22% of HER2 biologics patents, focusing on antibody-drug conjugates (ADCs) and cell therapies[1].
• Neurological and Psychiatric Disorders:
  Drugs targeting aromatic L-amino acid decarboxylase (AADC) — crucial for dopamine/serotonin synthesis — include 20+ molecules in development for Parkinson’s and AADC deficiency[9].

Regional Trends

• North America:
  Holds the largest market share ($814.4 billion patented drugs in 2022), driven by high R&D investment and prevalence of chronic diseases[13].
• Asia-Pacific:
  Fastest-growing region (5.5% CAGR for metabolic disorder treatments[2]), fueled by rising healthcare access and cost-effective production methods[12].

Production Innovations

• Fermentation Technology:
  Sustainable microbial production of AAAs is accelerating, with strains optimized for phenylalanine, tyrosine, and tryptophan to meet global demand (projected $74.8 billion amino acid market by 2035)[6][12].
• Plant-Based Alternatives:
  Shift toward plant-derived amino acids in nutraceuticals due to vegan and sustainability trends[10][12].

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Patent Landscape

Key Therapeutic Areas and Patents

Application	Patent Trends	Key Players
Cancer Therapeutics	HER2 biologics (1,003 patent families), ADC drugs, and LAT1 inhibitors[1][5][14]	Roche, Regents of the University of California
Metabolic Disorders	Enzyme replacement therapies (e.g., sapropterin for phenylketonuria)[2]	BioMarin, Merck KGaA
Neurology	AADC-targeted gene therapies and small molecules[9]	Pfizer, Biogen

Innovation Hotspots

• Biologics Optimization:
  64% of HER2 monoclonal antibody patents involve novel designs to reduce immunogenicity or enhance cytotoxicity[1].
• Covalent Drug Development:
  Electrophilic compounds targeting cysteine/lysine residues in enzymes (e.g., EGFR, BTK) account for 63% of covalent drug patents[8].
• Biosimilars Litigation:
  Patent disputes, like Amgen vs. Sandoz over denosumab biosimilars, highlight competitive pressures in biologics[15].

Emerging Technologies

• CRISPR and Metabolic Engineering:
  Host cells genetically modified to oxidize AAAs (e.g., US Patent 10,597,685) enable scalable production of therapeutic intermediates[3].
• Shikimate Pathway Engineering:
  Aminoshikimic acid derivatives are prioritized for antiviral and anticancer applications, with 76,321 compound-patent pairs in Alzheimer’s research[4][7].

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Competitive Strategies

• Collaborations:
  Biogen’s partnership with Eisai for ADUHELM commercialization[13] and academic-industry alliances for kinase inhibitor development[8].
• Patent Extensions:
  Companies like Roche leverage biosequence patents to prolong exclusivity, while generics face "patent thickets"[1][15].

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Challenges

• High Costs:
  Patented drugs remain inaccessible in low-income regions due to pricing (e.g., Kuvan costs ~$100,000/year)[2][13].
• Regulatory Hurdles:
  Only 36% of HER2 biologics patents are granted, reflecting stringent novelty requirements[1][4].

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"The field of HER2 biologics is dominated by Roche with 1,092 patent applications, reflecting the commercial potential of tyrosine-targeted therapies." [1]

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Future Outlook

• Precision Medicine:
  Biomarker-driven AAA therapies (e.g., RET inhibitors for neuroendocrine tumors) will dominate R&D[4].
• Biosimilar Expansion:
  Post-2025, denosumab and aflibercept biosimilars will intensify market competition[15].
• Sustainability:
  Fermentation-based AAA production could reduce costs by 20–30%, aligning with ESG goals[6][12].

This evolving landscape underscores the interplay between innovation, IP strategy, and unmet medical needs in leveraging aromatic amino acids for therapeutic breakthroughs.

References

1. https://sklqrcm.um.edu.mo/202308301n/
2. https://www.alliedmarketresearch.com/amino-acid-metabolism-disorders-treatment-market-A10868
3. https://www.osti.gov/biblio/1637795
4. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text
5. https://patents.google.com/patent/US7345068B2/en
6. https://www.biorxiv.org/content/10.1101/2024.11.25.625200v1.full.pdf
7. https://www.dovepress.com/current-perspectives-on-applications-of-shikimic-and-aminoshikimic-aci-peer-reviewed-fulltext-article-RRMC
8. https://pubmed.ncbi.nlm.nih.gov/39219095/
9. https://www.pharmaceutical-technology.com/data-insights/aromatic-l-amino-acid-decarboxylase-drugs-in-development/
10. https://www.marketsandmarkets.com/Market-Reports/food-amino-acids-market-113825875.html
11. https://en.wikipedia.org/wiki/Aromatic_amino_acid
12. https://www.globenewswire.com/news-release/2025/02/20/3029846/0/en/Global-Amino-Acids-Market-to-Reach-USD-74-832-0-million-by-2035-Driven-by-Rising-Demand-in-Nutrition-Pharmaceuticals-and-Animal-Feed-Future-Market-Insights-Inc.html
13. https://www.alliedmarketresearch.com/patented-drugs-market-A110993
14. https://pubchem.ncbi.nlm.nih.gov/patent/US7345068
15. https://www.fr.com/insights/thought-leadership/blogs/biologics-and-biosimilars-landscape-2024-ip-policy-and-market-developments/