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Last Updated: July 19, 2024

ALPROSTADIL - Generic Drug Details


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What are the generic sources for alprostadil and what is the scope of freedom to operate?

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. Four 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: 4
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 38
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

SponsorPhase
Kafrelsheikh UniversityN/A
First Hospital of Jilin UniversityPhase 4
The First Hospital of Jilin UniversityPhase 4

See all ALPROSTADIL clinical trials

Medical Subject Heading (MeSH) Categories for ALPROSTADIL

US Patents and Regulatory Information for ALPROSTADIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CAVERJECT alprostadil INJECTABLE;INJECTION 020755-001 Oct 31, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations EDEX alprostadil INJECTABLE;INJECTION 020649-003 Jun 12, 1997 AP RX Yes No ⤷  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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CAVERJECT IMPULSE alprostadil INJECTABLE;INJECTION 021212-002 Jun 11, 2002 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer CAVERJECT alprostadil INJECTABLE;INJECTION 020379-002 Jul 6, 1995 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer CAVERJECT alprostadil INJECTABLE;INJECTION 020379-004 May 19, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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