MIRALAX Drug Patent Profile
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Which patents cover Miralax, and when can generic versions of Miralax launch?
Miralax is a drug marketed by Bayer Healthcare Llc and is included in one NDA.
The generic ingredient in MIRALAX is polyethylene glycol 3350. There are four hundred and twenty-one drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350 profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Miralax
A generic version of MIRALAX was approved as polyethylene glycol 3350 by MYLAN on October 6th, 2009.
Summary for MIRALAX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 199 |
| Clinical Trials: | 37 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for MIRALAX |
| What excipients (inactive ingredients) are in MIRALAX? | MIRALAX excipients list |
| DailyMed Link: | MIRALAX at DailyMed |
Recent Clinical Trials for MIRALAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chad R. Tracy | Phase 4 |
| Indiana University | Phase 4 |
| Ferring Pharmaceuticals | Phase 1/Phase 2 |
Pharmacology for MIRALAX
| Drug Class | Osmotic Laxative |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
US Patents and Regulatory Information for MIRALAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | MIRALAX | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 022015-001 | Oct 6, 2006 | OTC | 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 |
