P2Y12 Platelet Inhibitor Drug Class List

Drugs in Drug Class: P2Y12 Platelet Inhibitor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	8,425,934*PED				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	RE46276*PED
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	10,300,065*PED				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No	8,425,934*PED				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No	RE46276*PED
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes

P2Y12 Platelet Inhibitor Market Analysis and Financial Projection

The P2Y12 platelet inhibitor market has undergone significant evolution driven by cardiovascular disease prevalence, patent expirations, and shifting therapeutic preferences. This analysis examines key trends shaping this $3.8B+ global sector projected to grow at 4.2% CAGR through 2032[8][5].

Market Dynamics

Therapeutic Landscape
Six clinically approved P2Y12 inhibitors dominate treatment protocols:

• Thienopyridines: Clopidogrel (Plavix®), prasugrel (Effient®)
• Non-thienopyridines: Ticagrelor (Brilinta®), cangrelor (Kengreal®)[1][6]

Growth Drivers

1. Epidemiological Pressures: CVD causes 659,000 annual U.S. deaths, necessitating antiplatelet therapies[4][8]
2. Therapeutic Advancements: Next-gen agents like ticagrelor show 90% bioavailability vs clopidogrel's 50%[6][16]
3. Emerging Markets: Middle-income countries saw 356.93% sales growth (2008-2018) vs 46.42% in high-income nations[2]

2023 Market Snapshot:
Global P2Y12 Sales: $2.3B[5]
U.S. Market Share: $215.7M (2021 base)[4]
Projected 2032 Value: $5.8B[8]

Generic Impact
Clopidogrel's 2012 patent expiration transformed market dynamics:

• Generic penetration reached 90% in U.S. prescriptions[3]
• Price reductions up to 50% post-generic entry[3]

Patent Landscape

Key Drug Patent Expirations

Drug	Brand Owner	Key Patent Expiry	Projected Generic Launch
Ticagrelor	AstraZeneca	2032-2035[10][12]	2035+ (ANDA litigation)
Cangrelor	Chiesi USA	2035[15]	2035
Prasugrel	Eli Lilly/Daiichi	2023-2025[14]	2028 (EU challenges)

Litigation Trends
Recent cases reveal strategic patent management:

• AstraZeneca vs Torrent Pharma (2021): Defended ticagrelor '065 patent against ANDA filer[12]
• Chiesi vs MSN Pharm (2021): Protected cangrelor formulation patents[18]

"Patent landscape analysis reveals 8 active patents protecting Kengreal® through 2035, with first ANDA challenges emerging in 2019." [15]

Competitive Strategies

Innovator Tactics

1. Secondary patenting (crystalline forms, dosing regimens)[17]
2. Lifecycle management: FDA approved ticagrelor for stroke prevention (2020)[8]
3. Targeted pricing: Ticagrelor maintains $3.80/day cost vs $0.21/day generics[3][8]

Generic/Biosimilar Approaches

• Paragraph IV certifications filed 4 years post-approval (NCE-1 date)[15]
• Complex API synthesis challenges (prasugrel requires 7-step process)[14]

Challenges & Opportunities

Clinical Considerations

• Bleeding Risk: Ticagrelor's dyspnea side effects limit adherence[4][7]
• Genotype Guidance: CYP2C19 testing reduces clopidogrel non-response[1][6]

Economic Pressures

• R&D costs per new molecular entity: $3.5M+[9]
• Ticagrelor price premium requires demonstrating 16% mortality benefit[16]

The sector faces transformative pressures from biosimilars and personalized medicine approaches. With 14,000+ patents in cardiovascular pharmacology[9], success requires balancing innovation, lifecycle management, and real-world evidence generation.

References

1. https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.850028/full
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC10976188/
3. https://pmarketresearch.com/hc/anticoccidial-drugs-market/antiplatelet-drugs-market
4. https://www.coherentmarketinsights.com/market-insight/us-p2y12-inhibitors-market-4983
5. https://www.researchandmarkets.com/reports/5797841/antiplatelet-drugs-market-report-forecast
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC8983962/
7. https://www.einpresswire.com/article/760529477/u-s-p2y12-inhibitors-market-projected-to-witness-substantial-growth-2024-2031-teva-pharmaceuticals-usa-cipla-biocon
8. https://www.alliedmarketresearch.com/antiplatelet-market-A10479
9. https://caldwelllaw.com/news/how-patent-landscape-analysis-drives-business-growth/
10. https://www.drugs.com/availability/generic-tazverik.html
11. https://www.lexisnexisip.com/resources/patent-landscape-analysis/
12. https://insight.rpxcorp.com/litigation_documents/14329606
13. https://casetext.com/case/sanofi-synthelabo
14. https://www.epo.org/en/boards-of-appeal/decisions/t192269eu1
15. https://pharsight.greyb.com/drug/kengreal-patent-expiration
16. https://www.epo.org/en/boards-of-appeal/decisions/t192049eu1
17. https://www.thepharmaletter.com/new-plavix-patent-for-sanofi-synthelabo
18. https://casetext.com/case/chiesi-us-inc-v-msn-pharm