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
| Sponsor | Phase |
|---|---|
| Kafrelsheikh University | N/A |
| First Hospital of Jilin University | Phase 4 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meitheal | ALPROSTADIL | alprostadil | INJECTABLE;INJECTION | 075196-001 | Apr 30, 1999 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-002 | Jun 11, 2002 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | EDEX | alprostadil | INJECTABLE;INJECTION | 020649-007 | Jul 30, 1998 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-002 | Jul 6, 1995 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-001 | Jul 6, 1995 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | PROSTIN VR PEDIATRIC | alprostadil | INJECTABLE;INJECTION | 018484-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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