LOMOTIL Drug Patent Profile
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When do Lomotil patents expire, and when can generic versions of Lomotil launch?
Lomotil is a drug marketed by Gd Searle Llc and Pfizer and is included in two NDAs.
The generic ingredient in LOMOTIL is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for LOMOTIL
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 23 |
Clinical Trials: | 5 |
Patent Applications: | 5,492 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LOMOTIL |
What excipients (inactive ingredients) are in LOMOTIL? | LOMOTIL excipients list |
DailyMed Link: | LOMOTIL at DailyMed |
Recent Clinical Trials for LOMOTIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Naia Pharmaceuticals | Phase 1/Phase 2 |
9 Meters Biopharma, Inc. | Phase 1/Phase 2 |
Napo Pharmaceuticals, Inc. | Phase 2 |
Pharmacology for LOMOTIL
Drug Class | Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for LOMOTIL
US Patents and Regulatory Information for LOMOTIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gd Searle Llc | LOMOTIL | atropine sulfate; diphenoxylate hydrochloride | SOLUTION;ORAL | 012699-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | LOMOTIL | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 012462-001 | Approved Prior to Jan 1, 1982 | AA | RX | Yes | Yes | ⤷ 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 |