BUTORPHANOL TARTRATE - Generic Drug Details
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What are the generic drug sources for butorphanol tartrate and what is the scope of freedom to operate?
Butorphanol tartrate
is the generic ingredient in four branded drugs marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apothecon, Apotex, Rising, and Bristol Myers Squibb, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for butorphanol tartrate. Four suppliers are listed for this compound.
Summary for BUTORPHANOL TARTRATE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 8 |
| NDAs: | 16 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 7 |
| Patent Applications: | 7,310 |
| Drug Prices: | Drug price trends for BUTORPHANOL TARTRATE |
| What excipients (inactive ingredients) are in BUTORPHANOL TARTRATE? | BUTORPHANOL TARTRATE excipients list |
| DailyMed Link: | BUTORPHANOL TARTRATE at DailyMed |
Recent Clinical Trials for BUTORPHANOL TARTRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Zhongshan Hospital | N/A |
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | Phase 4 |
| The First Affiliated Hospital with Nanjing Medical University | Phase 4 |
Pharmacology for BUTORPHANOL TARTRATE
| Drug Class | Opioid Agonist/Antagonist |
| Mechanism of Action | Competitive Opioid Antagonists Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for BUTORPHANOL TARTRATE
Anatomical Therapeutic Chemical (ATC) Classes for BUTORPHANOL TARTRATE
US Patents and Regulatory Information for BUTORPHANOL TARTRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | BUTORPHANOL TARTRATE PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 074620-001 | Jan 22, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | BUTORPHANOL TARTRATE PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 075170-001 | Sep 28, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | BUTORPHANOL TARTRATE | butorphanol tartrate | SPRAY, METERED;NASAL | 075499-001 | Dec 4, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | BUTORPHANOL TARTRATE | butorphanol tartrate | INJECTABLE;INJECTION | 075559-002 | Mar 20, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | STADOL | butorphanol tartrate | SPRAY, METERED;NASAL | 019890-001 | Dec 12, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Baxter Hlthcare Corp | BUTORPHANOL TARTRATE PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 075695-002 | Oct 23, 2001 | DISCN | 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 |
Expired US Patents for BUTORPHANOL TARTRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apothecon | STADOL PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 017857-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | STADOL | butorphanol tartrate | SPRAY, METERED;NASAL | 019890-001 | Dec 12, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Apothecon | STADOL PRESERVATIVE FREE | butorphanol tartrate | INJECTABLE;INJECTION | 017857-002 | Approved Prior to Jan 1, 1982 | ⤷ 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.
ISSN: 2162-2639
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