Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
McKinsey
Harvard Business School
Merck
Boehringer Ingelheim

Last Updated: September 30, 2022

Details for New Drug Application (NDA): 209410


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


NDA 209410 describes OSMOLEX ER, which is a drug marketed by Adamas Pharma and is included in one NDA. It is available from two suppliers. There are eighteen 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. Thirty suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 209410
Tradename:OSMOLEX ER
Applicant:Adamas Pharma
Ingredient:amantadine hydrochloride
Patents:18
Formulation / Manufacturing:see details
Pharmacology for NDA: 209410
Mechanism of Action M2 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 68025-021 68025-021-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-021-30)
OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-021 68025-021-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-021-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 129MG BASE
Approval Date:Feb 16, 2018TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 15, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
Patent:See Plans and PricingPatent Expiration:Feb 15, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
Patent:See Plans and PricingPatent Expiration:Feb 15, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Expired US Patents for NDA 209410

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Adamas Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 See Plans and Pricing See Plans and Pricing
Adamas Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 See Plans and Pricing See Plans and Pricing
Adamas Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Harvard Business School
McKinsey
McKesson
Mallinckrodt

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 verification 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.