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Last Updated: January 21, 2020

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Smithkline Beecham Company Profile

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What is the competitive landscape for SMITHKLINE BEECHAM, and when can generic versions of SMITHKLINE BEECHAM drugs launch?

SMITHKLINE BEECHAM has six approved drugs.

There are two US patents protecting SMITHKLINE BEECHAM drugs.

There are fifty-one patent family members on SMITHKLINE BEECHAM drugs in seventeen countries.

Summary for Smithkline Beecham
International Patents:51
US Patents:2
Tradenames:6
Ingredients:6
NDAs:6
Drug Master File Entries: 2
Patent Litigation for Smithkline Beecham: See patent lawsuits for Smithkline Beecham

Drugs and US Patents for Smithkline Beecham

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Smithkline Beecham RELAFEN nabumetone TABLET;ORAL 019583-002 Dec 24, 1991 DISCN Yes No   Start Trial   Start Trial
Smithkline Beecham DYNACIRC isradipine CAPSULE;ORAL 019546-002 Dec 20, 1990 DISCN Yes No   Start Trial   Start Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 DISCN No No   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 AB RX Yes No 7,268,156*PED   Start Trial Y   Start Trial
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-001 Sep 14, 1995 AB RX Yes No   Start Trial   Start Trial
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-004 May 29, 1997 AB RX Yes No   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Smithkline Beecham

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 4,375,547   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 RE40000*PED   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 5,760,069*PED   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 5,760,069*PED   Start Trial
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-002 Sep 14, 1995 4,503,067*PED   Start Trial
Smithkline Beecham RELAFEN nabumetone TABLET;ORAL 019583-001 Dec 24, 1991 4,420,639*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SMITHKLINE BEECHAM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 40 mg ➤ Subscribe 2007-12-21
➤ Subscribe Oral Solution 15 mg/mL ➤ Subscribe 2008-05-14
➤ Subscribe Extended-release Capsules 10 mg and 20 mg ➤ Subscribe 2008-03-18
➤ Subscribe Extended-release Capsules 80 mg ➤ Subscribe 2007-11-19
➤ Subscribe Capsules 1 g ➤ Subscribe 2008-11-10
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Dow
Johnson and Johnson
Baxter
McKinsey

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