Propantheline bromide - Generic Drug Details
What are the generic sources for propantheline bromide and what is the scope of freedom to operate?
Propantheline bromide
is the generic ingredient in two branded drugs marketed by Gd Searle Llc, Shire, Ascot, Heather, Hikma, Impax Labs, Mylan, Par Pharm, Pvt Form, Sandoz, Tablicaps, and Watson Labs, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.Summary for propantheline bromide
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 13 |
| Drug Master File Entries: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 2 |
| Patent Applications: | 2,566 |
| What excipients (inactive ingredients) are in propantheline bromide? | propantheline bromide excipients list |
| DailyMed Link: | propantheline bromide at DailyMed |
Recent Clinical Trials for propantheline bromide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Universitário Professor Edgard Santos | Phase 1 |
| Chongqing Medical University | Phase 4 |
Medical Subject Heading (MeSH) Categories for propantheline bromide
Anatomical Therapeutic Chemical (ATC) Classes for propantheline bromide
US Patents and Regulatory Information for propantheline bromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 083029-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gd Searle Llc | PRO-BANTHINE | propantheline bromide | INJECTABLE;INJECTION | 008843-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Impax Labs | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 084541-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mylan | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 083706-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 080927-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ascot | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 087663-001 | Oct 25, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Shire | PRO-BANTHINE | propantheline bromide | TABLET;ORAL | 008732-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
