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Last Updated: February 22, 2024

Alprostadil - Generic Drug Details


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What are the generic drug 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, Auxilium Pharms Llc, 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: 38
Patent Applications: 6,590
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
The First Hospital of Jilin UniversityPhase 4
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma ALPROSTADIL alprostadil INJECTABLE;INJECTION 074815-001 Jan 20, 1998 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Auxilium Pharms Llc EDEX alprostadil INJECTABLE;INJECTION 020649-003 Jun 12, 1997 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Auxilium Pharms Llc EDEX alprostadil INJECTABLE;INJECTION 020649-006 Jul 30, 1998 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Auxilium Pharms Llc EDEX alprostadil INJECTABLE;INJECTION 020649-007 Jul 30, 1998 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 ⤷  Try a Trial ⤷  Try a Trial
Pfizer CAVERJECT alprostadil INJECTABLE;INJECTION 020379-003 Jun 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
Pfizer CAVERJECT alprostadil INJECTABLE;INJECTION 020379-002 Jul 6, 1995 ⤷  Try a Trial ⤷  Try a Trial
Pfizer CAVERJECT IMPULSE alprostadil INJECTABLE;INJECTION 021212-001 Jun 11, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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