Chloroprocaine hydrochloride - Generic Drug Details
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What are the generic drug sources for chloroprocaine hydrochloride and what is the scope of freedom to operate?
Chloroprocaine hydrochloride
is the generic ingredient in five branded drugs marketed by Harrow Eye, Hikma, Hospira, Fresenius Kabi Usa, and B Braun Medical Inc, and is included in six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Chloroprocaine hydrochloride has fifty-three patent family members in thirty-six countries.
There are two drug master file entries for chloroprocaine hydrochloride. Six suppliers are listed for this compound.
Summary for chloroprocaine hydrochloride
| International Patents: | 53 |
| US Patents: | 3 |
| Tradenames: | 5 |
| Applicants: | 5 |
| NDAs: | 6 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 35 |
| Patent Applications: | 1,180 |
| What excipients (inactive ingredients) are in chloroprocaine hydrochloride? | chloroprocaine hydrochloride excipients list |
| DailyMed Link: | chloroprocaine hydrochloride at DailyMed |
Recent Clinical Trials for chloroprocaine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 3 |
| Sintetica SA | Phase 2/Phase 3 |
| Sintetica SA | Phase 1/Phase 2 |
Pharmacology for chloroprocaine hydrochloride
| Drug Class | Ester Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for chloroprocaine hydrochloride
US Patents and Regulatory Information for chloroprocaine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | NESACAINE-MPF | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435-006 | May 2, 1996 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | NESACAINE-MPF | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | CHLOROPROCAINE HYDROCHLORIDE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 087446-001 | Apr 16, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | NESACAINE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435-002 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Harrow Eye | IHEEZO | chloroprocaine hydrochloride | GEL;OPHTHALMIC | 216227-001 | Sep 27, 2022 | 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 |
International Patents for chloroprocaine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Costa Rica | 20200133 | FORMULACIONES TÓPICAS DE CLOROPROCAÍNA Y MÉTODOS PARA UTILIZAR LAS MSIMAS (TOPICAL FORMULATIONS OF CHLOROPROCAINE) | ⤷ Sign Up |
| Australia | 2013356855 | Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration | ⤷ Sign Up |
| Argentina | 099443 | COMPOSICIÓN FARMACÉUTICA A BASE DE CLOROPROCAÍNA PARA LA ADMINISTRACIÓN INTRATECAL REPETIDA | ⤷ Sign Up |
| Colombia | 2020002985 | Formulaciones tópicas de cloroprocaína | ⤷ Sign Up |
| South Korea | 102162587 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated 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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