ALPROSTADIL Drug Patent Profile
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Which patents cover Alprostadil, and when can generic versions of Alprostadil launch?
Alprostadil is a drug marketed by Hikma and Meitheal and is included in two NDAs.
The generic ingredient in ALPROSTADIL 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 Alprostadil
A generic version of ALPROSTADIL was approved as alprostadil by HIKMA on January 20th, 1998.
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Questions you can ask:
- What is the 5 year forecast for ALPROSTADIL?
- What are the global sales for ALPROSTADIL?
- What is Average Wholesale Price for ALPROSTADIL?
Summary for ALPROSTADIL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 39 |
| Patent Applications: | 4,231 |
| 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 |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | ALPROSTADIL | alprostadil | INJECTABLE;INJECTION | 074815-001 | Jan 20, 1998 | AP | RX | 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 |
