Aminoketone Drug Class List

Drugs in Drug Class: Aminoketone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

Aminoketone Market Analysis and Financial Projection

The aminoketone drug class, characterized by compounds containing an amino group attached to a ketone backbone, plays a significant role in treating conditions ranging from depression to metabolic disorders. The market dynamics and patent landscape reveal a complex interplay of growth drivers, competitive strategies, and evolving intellectual property challenges.

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Market Dynamics

Growth Drivers and Market Size

• Amino Acid Metabolism Disorders Treatment: Valued at $630.9 million in 2021, this market is projected to reach $961.8 million by 2031 (CAGR: 4.3%)[1]. Key players include Teva Pharmaceutical, GlaxoSmithKline, and BioMarin Pharmaceutical. Growth is fueled by rising disease prevalence and R&D investments, though high treatment costs and side effects pose challenges[1][3].
• Pharmaceutical Amino Acids: The broader sector, valued at $6.14 billion in 2024, is driven by demand for protein-based therapeutics and chronic disease treatments. Companies like Merck and Ajinomoto lead in synthesis and production innovations[3].
• Antidepressants: Bupropion, a prominent aminoketone, competes in the expanding antidepressant market. Aplenzin (a bupropion variant) leverages once-daily dosing and lower weight gain risks[6][15], while ketamine derivatives—projected to grow from $437.75 million (2023) to $5.18 billion by 2030 (CAGR: 42.35%)—are gaining traction for treatment-resistant depression[12][13].

Regional Trends

• North America dominates due to advanced healthcare infrastructure and high demand for therapies like sapropterin[1].
• Asia-Pacific is the fastest-growing region (CAGR: 5.5%), driven by increasing diagnosis rates and healthcare expenditure[1][3].

Distribution Channels

• Retail pharmacies currently lead, but online providers are growing rapidly (6.0% CAGR) post-COVID-19 due to convenience[1].

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Patent Landscape

Key Patents and Innovations

1. Synthesis Methods:

   • US3254124A (1964, expired): Covered aminoketone production via hydroxyketone rearrangement[2][7].
   • Bupropion Derivatives: IntelGenx’s sustained-release formulation patent (expiring 2027) and hydrobromide salt patents (e.g., US7671094) highlight strategies to extend exclusivity[16][19].

2. Formulation Patents:

   • Ketamine Combinations: PharmaTher’s KETABET™ (ketamine + betaine) holds U.S. and international patents until 2036[11]. Clearmind Medicine is exploring ketamine-N-acylethanolamine combinations[14].

3. Challenges:

   • Patent Thickets: Overlapping patents on biologics (e.g., ritonavir) complicate generics entry[4][5]. For aminoketones, expired core patents (e.g., bupropion’s original synthesis) have enabled generics, while later patents protect formulations[17][20].
   • Antitrust Issues: Settlements like the Wellbutrin XL case delayed generics but were upheld as pro-competitive due to licensing and supply agreements[17].

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Competitive Strategies

• Differentiation: Aplenzin emphasizes dosing convenience and reduced side effects[6], while ketamine clinics focus on novel delivery systems (e.g., microneedle patches)[11][13].
• Partnerships: Collaborations between pharmaceutical firms and biotech startups aim to innovate in regenerative medicine and combination therapies[3][14].

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Challenges and Opportunities

Challenges	Opportunities
Generic competition (e.g., bupropion)[20]	Expansion in Asia-Pacific markets[1][3]
Regulatory hurdles for biologics[4][5]	Development of sustained-release and combo therapies[11][16]
High production costs[3]	Sustainable synthesis methods (e.g., microbial fermentation)[3]

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Key Takeaways

• The aminoketone market is expanding, driven by mental health and metabolic disorder treatments.
• Patent strategies focus on formulations and combinations to counter generics.
• Regional growth in Asia-Pacific and online distribution channels present untapped potential.
• Innovation in delivery systems (e.g., ketamine patches) and sustainable production will shape future competitiveness.

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“The granted patents and published studies further validate the potential of KETABET™ and support the Company's ongoing investigator-led clinical programs.” – PharmaTher Holdings Ltd.[11]

References

1. https://www.alliedmarketresearch.com/amino-acid-metabolism-disorders-treatment-market-A10868
2. https://patents.google.com/patent/US3254124A/en
3. https://datahorizzonresearch.com/pharmaceutical-amino-acids-market-4819
4. https://www.bu.edu/bulawreview/files/2022/03/HUSTAD.pdf
5. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
6. https://www.drugpatentwatch.com/p/drug-sales/drugname/APLENZIN
7. https://patents.google.com/patent/US3254124A/un
8. https://www.ojp.gov/pdffiles1/nij/grants/250125.pdf
9. https://pubs.acs.org/doi/10.1021/jacs.4c09434
10. https://pubs.acs.org/doi/10.1021/acs.oprd.1c00407
11. https://www.biospace.com/pharmather-announces-grant-of-u-s-patent-on-ketamine-formulation
12. https://www.maximizemarketresearch.com/market-report/ketamine-treatment-market/216827/
13. https://www.grandviewresearch.com/industry-analysis/us-ketamine-clinics-market-report
14. https://www.biospace.com/drug-development/clearmind-medicine-announces-publication-of-its-patent-application-for-innovative-ketamine-based-combination-treatment
15. https://en.wikipedia.org/wiki/Bupropion
16. https://intelgenx.com/newsrooms/newsrooms1/19-2010/66-intelgenx-granted-bupropion-patent
17. https://casetext.com/case/in-re-wellbutrin-xl-antitrust-litig-5
18. https://www.researchandmarkets.com/reports/5659576/contrave-naltrexon-bupropion-drug-insight-and
19. https://patents.justia.com/patent/7671094
20. https://www.thebrandprotectionblog.com/2012/10/fda-says-wellbutrin-generic-really-isnt-generic-after-all/