Alprostadil - Generic Drug Details
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What are the generic drug 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, 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
Sponsor | Phase |
---|---|
Kafrelsheikh University | N/A |
The First Hospital of Jilin University | Phase 4 |
First Hospital of Jilin University | Phase 4 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Auxilium Pharms Llc | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-005 | Jul 30, 1998 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | PROSTIN VR PEDIATRIC | alprostadil | INJECTABLE;INJECTION | 018484-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-002 | Jun 11, 2002 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-004 | May 19, 1997 | AP | RX | Yes | Yes | ⤷ 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 | |||
Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020755-003 | Oct 1, 1997 | DISCN | No | No | ⤷ 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
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