Cyproheptadine hydrochloride - Generic Drug Details
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What are the generic sources for cyproheptadine hydrochloride and what is the scope of freedom to operate?
Cyproheptadine hydrochloride
is the generic ingredient in two branded drugs marketed by Actavis Mid Atlantic, Chartwell Molecular, Elysium, Halsey, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, Tris Pharma Inc, Merck, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Strides Pharma, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for cyproheptadine hydrochloride. Twenty-three suppliers are listed for this compound.
Summary for cyproheptadine hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 32 |
| NDAs: | 41 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 29 |
| Patent Applications: | 1,471 |
| What excipients (inactive ingredients) are in cyproheptadine hydrochloride? | cyproheptadine hydrochloride excipients list |
| DailyMed Link: | cyproheptadine hydrochloride at DailyMed |
Recent Clinical Trials for cyproheptadine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kinnov Therapeutics | Phase 1 |
| Corey Hawes | Phase 2/Phase 3 |
| National Center for Advancing Translational Sciences (NCATS) | Phase 2/Phase 3 |
Medical Subject Heading (MeSH) Categories for cyproheptadine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for cyproheptadine hydrochloride
US Patents and Regulatory Information for cyproheptadine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 040668-001 | Jun 28, 2006 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Quagen | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 212423-001 | May 22, 2019 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Naska | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 089021-001 | Dec 21, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharm Assoc | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 091295-001 | Mar 28, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Molecular | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 203191-001 | Jul 13, 2017 | AA | 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 |
