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 |
Formulation / Manufacturing: | see details |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | CHLOROPROCAINE HYDROCHLORIDE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 087447-001 | Apr 16, 1982 | DISCN | No | 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 | ||||
Fresenius Kabi Usa | NESACAINE-MPF | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435-006 | May 2, 1996 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | CHLOROPROCAINE HYDROCHLORIDE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 040273-001 | Sep 9, 1998 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | NESACAINE | chloroprocaine hydrochloride | INJECTABLE;INJECTION | 009435-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
B Braun Medical Inc | CLOROTEKAL | chloroprocaine hydrochloride | SOLUTION;INTRATHECAL | 208791-001 | Sep 26, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
---|---|---|---|
Russian Federation | 2648823 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ОСНОВЕ ХЛОРПРОКАИНА ДЛЯ ПОВТОРНОГО ИНТРАТЕКАЛЬНОГО ВВЕДЕНИЯ (CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION) | ⤷ Sign Up |
Spain | 2441790 | ⤷ Sign Up | |
Philippines | 12020550029 | TOPICAL FORMULATIONS OF CHLOROPROCAINE | ⤷ Sign Up |
Canada | 2621015 | NOUVELLE UTILISATION D'UNE COMPOSITION COMPRENANT DU CHLORHYDRATE DE CHLOROPROCAINE, UNE NOUVELLE COMPOSITION COMPRENANT DU CHLORHYDRATEDE CHLOROPROCAINE ET UN PROCEDE PERMETTANTDE LA FABRIQUER (NEW USE FOR A COMPOSITION COMPRISING CHLOROPROCAINE HCL, A NEW COMPOSITION COMPRISING CHLOROPROCAINE HCL AND A METHOD FOR ITS MANUFACTURE) | ⤷ Sign Up |
Argentina | 099443 | COMPOSICIÓN FARMACÉUTICA A BASE DE CLOROPROCAÍNA PARA LA ADMINISTRACIÓN INTRATECAL REPETIDA | ⤷ Sign Up |
South Korea | 102162587 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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