Prasugrel hydrochloride - Generic Drug Details

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What are the generic drug sources for prasugrel hydrochloride and what is the scope of freedom to operate?

Prasugrel hydrochloride is the generic ingredient in three branded drugs marketed by Cosette, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for prasugrel hydrochloride. Nine suppliers are listed for this compound.

Summary for prasugrel hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	226
Patent Applications:	121
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for prasugrel hydrochloride
What excipients (inactive ingredients) are in prasugrel hydrochloride?	prasugrel hydrochloride excipients list
DailyMed Link:	prasugrel hydrochloride at DailyMed

Recent Clinical Trials for prasugrel hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ferdinando Varbella	Phase 3
Azienda Ospedaliera Universitaria Policlinico "G. Martino"	Phase 3
Gianluca Di Bella	Phase 3

See all prasugrel hydrochloride clinical trials

Pharmacology for prasugrel hydrochloride

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for prasugrel hydrochloride

Platelet Aggregation Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for prasugrel hydrochloride

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for PRASUGREL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EFFIENT	Tablets	prasugrel hydrochloride	5 mg and 10 mg	022307	17	2013-07-10

US Patents and Regulatory Information for prasugrel hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205790-002	Oct 16, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205790-001	Oct 16, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205913-002	Jun 19, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205888-002	Oct 16, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Panacea	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205897-001	Oct 16, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unichem	PRASUGREL HYDROCHLORIDE	prasugrel hydrochloride	TABLET;ORAL	213315-002	Aug 28, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for prasugrel hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for prasugrel hydrochloride

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Prasugrel Mylan	prasugrel	EMEA/H/C/004644 Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).	Authorised	yes	no	no	2018-05-15
Substipharm	Efient	prasugrel	EMEA/H/C/000984 Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).	Authorised	no	no	no	2009-02-24
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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