Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Medtronic
Baxter
Cantor Fitzgerald
Chubb

Generated: June 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209410

« Back to Dashboard

NDA 209410 describes OSMOLEX ER, which is a drug marketed by Osmotica Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the OSMOLEX ER profile page.

The generic ingredient in OSMOLEX ER is amantadine hydrochloride. There are seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 209410
Tradename:OSMOLEX ER
Applicant:Osmotica Pharm
Ingredient:amantadine hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 209410
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 209410
Suppliers and Packaging for NDA: 209410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-075 68025-075-14 2 BLISTER PACK in 1 CARTON (68025-075-14) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68025-075-07)
OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-075 68025-075-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 129MG BASE
Approval Date:Feb 16, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 13, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Nov 28, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 193MG BASE
Approval Date:Feb 16, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 13, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 209410

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 ➤ Try a Free Trial ➤ Try a Free Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
Fuji
Farmers Insurance
Accenture
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.