Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Harvard Business School
Medtronic
McKesson
McKinsey

Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019270

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 019270 describes BETOPTIC, which is a drug marketed by Sandoz Inc, Alcon, and Novartis, and is included in three NDAs. It is available from one supplier. Additional details are available on the BETOPTIC profile page.

The generic ingredient in BETOPTIC is betaxolol hydrochloride; pilocarpine hydrochloride. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; pilocarpine hydrochloride profile page.
Summary for 019270
Tradename:BETOPTIC
Applicant:Sandoz Inc
Ingredient:betaxolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019270
Suppliers and Packaging for NDA: 019270
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270 NDA AUTHORIZED GENERIC Sandoz Inc 61314-245 61314-245-01 5 mL in 1 BOTTLE, PLASTIC (61314-245-01)
BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270 NDA AUTHORIZED GENERIC Sandoz Inc 61314-245 61314-245-02 15 mL in 1 BOTTLE, PLASTIC (61314-245-02)
Paragraph IV (Patent) Challenges for 019270
Tradename Dosage Ingredient NDA Submissiondate
BETOPTIC SOLUTION/DROPS;OPHTHALMIC betaxolol hydrochloride 019270

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Aug 30, 1985TE:ATRLD:Yes

Expired US Patents for NDA 019270

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985   Start Trial   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985   Start Trial   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985   Start Trial   Start Trial
>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:

Baxter
Merck
Mallinckrodt
McKinsey
Medtronic
Colorcon

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.