Propantheline bromide - Generic Drug Details
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What are the generic drug sources for propantheline bromide and what is the scope of patent protection?
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.There are seven drug master file entries for propantheline bromide.
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: | 3,450 |
Formulation / Manufacturing: | see details |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 080927-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Shire | PRO-BANTHINE | propantheline bromide | TABLET;ORAL | 008732-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Shire | PRO-BANTHINE | propantheline bromide | TABLET;ORAL | 008732-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Heather | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 085780-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Impax Labs | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 084541-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | PROPANTHELINE BROMIDE | propantheline bromide | TABLET;ORAL | 080927-002 | Approved Prior to Jan 1, 1982 | DISCN | 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 |