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, Lyne, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Tris Pharma Inc, Merck, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, Fosun Pharma, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Rising, 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: | 34 |
| NDAs: | 41 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 27 |
| Patent Applications: | 1,484 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Bronx VA Medical Center | Phase 1 |
| Laval University | Phase 2 |
| Canadian Institutes of Health Research (CIHR) | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Quagen | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | TABLET;ORAL | 212491-001 | Feb 24, 2021 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Halsey | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | TABLET;ORAL | 089057-001 | Jul 3, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Quagen | CYPROHEPTADINE HYDROCHLORIDE | cyproheptadine hydrochloride | SYRUP;ORAL | 212423-001 | May 22, 2019 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
