SEVOFLURANE - Generic Drug Details
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What are the generic sources for sevoflurane and what is the scope of freedom to operate?
Sevoflurane
is the generic ingredient in three branded drugs marketed by Baxter Hlthcare, Halocarbon Prods, Shandong, Shanghai Hengrui, Piramal Critical, and Abbvie, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for sevoflurane. Nine suppliers are listed for this compound.
Summary for SEVOFLURANE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 856 |
| Patent Applications: | 3,705 |
| Drug Prices: | Drug price trends for SEVOFLURANE |
| What excipients (inactive ingredients) are in SEVOFLURANE? | SEVOFLURANE excipients list |
| DailyMed Link: | SEVOFLURANE at DailyMed |
Recent Clinical Trials for SEVOFLURANE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Keith M. Vogt, MD, PhD | Phase 1 |
| National Institute of General Medical Sciences (NIGMS) | Phase 1 |
| SanQing Jin | N/A |
Pharmacology for SEVOFLURANE
| Drug Class | General Anesthetic |
| Physiological Effect | General Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for SEVOFLURANE
US Patents and Regulatory Information for SEVOFLURANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shanghai Hengrui | SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 203793-001 | Nov 3, 2015 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | ULTANE | sevoflurane | LIQUID;INHALATION | 020478-001 | Jun 7, 1995 | AN | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Halocarbon Prods | SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 078650-001 | Nov 19, 2007 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Shandong | SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 214382-001 | Aug 18, 2023 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Baxter Hlthcare | SEVOFLURANE | sevoflurane | LIQUID;INHALATION | 075895-001 | Jul 2, 2002 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Piramal Critical | SOJOURN | sevoflurane | LIQUID;INHALATION | 077867-001 | May 2, 2007 | AN | 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 |
Expired US Patents for SEVOFLURANE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ULTANE | sevoflurane | LIQUID;INHALATION | 020478-001 | Jun 7, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ULTANE | sevoflurane | LIQUID;INHALATION | 020478-001 | Jun 7, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ULTANE | sevoflurane | LIQUID;INHALATION | 020478-001 | Jun 7, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ULTANE | sevoflurane | LIQUID;INHALATION | 020478-001 | Jun 7, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SEVOFLURANE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Chanelle Pharmaceuticals Manufacturing Limited | Sevohale (previously known as Sevocalm) | sevoflurane | EMEA/V/C/004199 For the induction and maintenance of anaesthesia. |
Authorised | yes | no | no | 2016-06-21 | |
| Zoetis Belgium SA | SevoFlo | sevoflurane | EMEA/V/C/000072 For the induction and maintenance of anaesthesia in dogs and cats. |
Authorised | no | no | no | 2002-12-11 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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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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