Alprostadil - Generic Drug Details

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What are the generic sources for alprostadil and what is the scope of patent protection?

Alprostadil is the generic ingredient in six branded drugs marketed by Hikma, Meitheal, Pfizer, Endo Operations, and Mylan Speciality Lp, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for alprostadil. Five suppliers are listed for this compound.

Summary for alprostadil

US Patents:	0
Tradenames:	6
Applicants:	5
NDAs:	8
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	39
Patent Applications:	6,072
What excipients (inactive ingredients) are in alprostadil?	alprostadil excipients list
DailyMed Link:	alprostadil at DailyMed

Recent Clinical Trials for alprostadil

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

Sponsor	Phase
University Hospital, Rouen	Phase 3
Kafrelsheikh University	N/A
The First Hospital of Jilin University	Phase 4

See all alprostadil clinical trials

Pharmacology for alprostadil

Drug Class	Prostaglandin Analog Prostaglandin E1 Agonist
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

Medical Subject Heading (MeSH) Categories for alprostadil

Platelet Aggregation Inhibitors
Urological Agents
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for alprostadil

C01EA	Prostaglandins
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for alprostadil

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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
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-004	May 19, 1997	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020755-002	Oct 1, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020755-003	Oct 1, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	ALPROSTADIL	alprostadil	INJECTABLE;INJECTION	075196-001	Apr 30, 1999	AP	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 alprostadil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	⤷ Sign Up	⤷ Sign Up
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	⤷ Sign Up	⤷ Sign Up
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-003	Jun 27, 1996	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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