Penem Antibacterial Drug Class List

Drugs in Drug Class: Penem Antibacterial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790-001	Apr 16, 2018	AP	RX	No	No
Eugia Pharma	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	209133-001	Jun 25, 2018	AP	RX	No	No
Gland Pharma Ltd	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	212040-001	Mar 26, 2021	AP	RX	No	No
Qilu Antibiotics	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	218067-001	Oct 31, 2024	AP	RX	No	No
Savior Lifetec Corp	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	207647-001	Mar 19, 2019	AP	RX	No	No

Penem Antibacterial Market Analysis and Financial Projection

The penem antibacterial drug class, a critical subset of beta-lactam antibiotics, is experiencing dynamic growth driven by rising antimicrobial resistance and innovation in drug development. Here's an analysis of the market dynamics and patent landscape:

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Market Dynamics

Growth Projections

• The global carbapenem-based antibiotics market was valued at $4.6 billion in 2024, projected to reach $6.09 billion by 2029 at a 6% CAGR[4][6].
• Penem antibiotics specifically (including carbapenems) are forecast to grow at a 10.3% CAGR, driven by multi-drug resistant (MDR) infections[16][17].

Key Drivers

1. Antibiotic Resistance: Over 78% of bacterial infections diagnosed in 2023 involved resistant strains, necessitating last-resort penems like meropenem and imipenem[4][6].
2. Demographic Shifts: Aging populations and surgical procedures increase susceptibility to hospital-acquired infections (HAIs)[6][12].
3. Healthcare Investments: Expanding infrastructure in emerging markets improves access to advanced antibiotics[5][6].

Market Segments

• Leading Drugs: Meropenem dominates with 54.8% market share in 2022 due to broad-spectrum efficacy[6].
• Applications: Urinary tract infections (UTIs) drive $1.4 billion in revenue (2023), followed by bloodstream and intra-abdominal infections[12].

Regional Trends

• North America and Europe lead in consumption, but Asia-Pacific is the fastest-growing region due to healthcare expansion[13][17].

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Patent Landscape

Historical Patents

• US5830889A (1998): Covered penem esters with enhanced bioavailability, expired in 2018[2].
• US5506225A (1996): Protected penem compounds with hydrolyzable ester groups, now expired[16].

Recent Innovations

1. NOSO-502 (Nosopharm): A novel ribosome-targeting penem with a US patent granted in 2020 for treating carbapenem-resistant Enterobacteriaceae (CRE)[7].
2. Sulopenem (Iterum Therapeutics): Received FDA approval in 2024 as the first oral penem for UTIs, protected until 2039[14][15].
3. WO-2022233886-A1 (Discuva Ltd., 2022): Targets Gram-negative bacteria like Haemophilus and Enterobacterales[10].

Strategic Trends

• Combination Therapies: Blending penems with beta-lactamase inhibitors (e.g., vaborbactam) to counter resistance[6][8].
• Oral Formulations: Companies like GSK and Spero Therapeutics are advancing oral carbapenems (e.g., tebipenem HBr) for outpatient use[11][15].

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Competitive Landscape

Major Players

• Top Manufacturers: Menarini Group, Pfizer, Sun Pharma, and Aurobindo Pharma[6][9].
• Emerging Developers: Nosopharm (NOSO-502) and Iterum Therapeutics (sulopenem) focus on niche-resistant infections[7][14].

Partnerships

• Menarini-SciClone: Collaboration to market meropenem/vaborbactam in China[6].
• Spero-GSK: Licensing deal for tebipenem HBr outside Asia[11].

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Challenges and Opportunities

• Generics Competition: Patent expirations have enabled generic manufacturers to lower costs, improving accessibility in LMICs[1][4].
• Stewardship Programs: Rising awareness limits overuse, but precision medicine approaches aim to optimize dosing[4][12].
• Pipeline Gaps: Only 2 new penems (sulopenem, NOSO-502) entered Phase 3 trials between 2020–2025, highlighting R&D hurdles[7][15].

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Key Takeaways

1. The penem market is expanding due to antimicrobial resistance and demographic pressures.
2. Oral formulations and combination therapies are critical innovations.
3. Patent cliffs have enabled generic penetration, but novel patents target resistance mechanisms and delivery methods.
4. Strategic partnerships and regulatory incentives (e.g., QIDP status) accelerate pipeline development.

“The award of a US patent for our clinical candidate NOSO-502 is a key milestone... significantly more incentive for industrial partners to in-license the program.” — Philippe Villain-Guillot, CEO of Nosopharm[7]

References

1. https://www.globenewswire.com/news-release/2022/05/13/2442739/28124/en/Carbapenem-Based-Antibiotics-Global-Market-Outlook-2022-2028-A-US-5-346-62-Million-Market-by-2028.html
2. https://patents.google.com/patent/US5830889A/en
3. https://pubmed.ncbi.nlm.nih.gov/12528302/
4. https://www.researchandmarkets.com/reports/5939510/carbapenem-based-antibiotics-market-report
5. https://www.verifiedmarketresearch.com/product/carbapenem-api-market/
6. https://www.grandviewresearch.com/industry-analysis/carbapenem-market-report
7. https://www.labmate-online.com/news/news-and-views/5/nosopharm/first-in-class-antibiotic-receives-patent-protection/52156
8. https://www.explorationpub.com/Journals/eds/Article/100813
9. https://www.qyresearch.com/reports/4663339/penem-antibiotics
10. https://pubchem.ncbi.nlm.nih.gov/patent/WO-2022233886-A1
11. https://www.sperotherapeutics.com/pipeline
12. https://www.gminsights.com/industry-analysis/carbapenem-market
13. https://www.qyresearch.com/reports/4663489/penem-antibiotic-intermediates
14. https://www.iterumtx.com/news/press-releases/detail/102/iterum-therapeutics-announces-issuance-of-allowance-for-a
15. https://www.medcentral.com/infectious/whats-new-in-antibiotics
16. https://patents.google.com/patent/US5506225A/en
17. https://github.com/pllahoithana9/Market-Research-Report-List-1/blob/main/penem-antibiotics-market.md