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Alprostadil - Generic Drug Details
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What are the generic sources for alprostadil and what is the scope of patent protection?
Alprostadil
is the generic ingredient in six branded drugs marketed by Teva Pharms Usa, West-ward Pharms Int, Pfizer, Pharmacia And Upjohn, 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: | 6 |
| NDAs: | 8 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 78 |
| Clinical Trials: | 34 |
| Patent Applications: | 4,011 |
| DailyMed Link: | alprostadil at DailyMed |
Recent Clinical Trials for alprostadil
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| Sponsor | Phase |
|---|---|
| Assiut University | Early Phase 1 |
| Assiut University | Phase 4 |
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 2 |
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 | 020649-006 | Jul 30, 1998 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-003 | Jun 27, 1996 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pfizer | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020755-003 | Oct 1, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Pharms Usa | ALPROSTADIL | alprostadil | INJECTABLE;INJECTION | 075196-001 | Apr 30, 1999 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-001 | Jul 6, 1995 | AP | RX | Yes | No | Start Trial | Start Trial | Start 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 | 020700-001 | Nov 19, 1996 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-002 | Jun 11, 2002 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-004 | May 19, 1997 | Start Trial | Start Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-002 | Nov 19, 1996 | Start Trial | Start Trial |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | Start Trial | Start Trial |
| Pharmacia And Upjohn | CAVERJECT | alprostadil | INJECTABLE;INJECTION | 020379-003 | Jun 27, 1996 | Start Trial | Start Trial |
| >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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