EDEX Drug Patent Profile
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When do Edex patents expire, and what generic alternatives are available?
Edex is a drug marketed by Auxilium Pharms Llc and is included in one NDA.
The generic ingredient in EDEX is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Edex
A generic version of EDEX was approved as alprostadil by HIKMA on January 20th, 1998.
Summary for EDEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Patent Applications: | 4,457 |
Drug Prices: | Drug price information for EDEX |
What excipients (inactive ingredients) are in EDEX? | EDEX excipients list |
DailyMed Link: | EDEX at DailyMed |
Pharmacology for EDEX
Drug Class | Prostaglandin Analog Prostaglandin E1 Agonist |
Mechanism of Action | Prostaglandin Receptor Agonists |
Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for EDEX
US Patents and Regulatory Information for EDEX
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 | 020649-001 | Jun 12, 1997 | DISCN | No | No | ⤷ 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 | ||||
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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |