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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

ORTIKOS Drug Profile

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Which patents cover Ortikos, and what generic alternatives are available?

Ortikos is a drug marketed by Sun Pharma Global and is included in one NDA. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in ORTIKOS is budesonide. There are twenty-two drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for ORTIKOS
International Patents:3
US Patents:2
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
DailyMed Link:ORTIKOS at DailyMed
Drug patent expirations by year for ORTIKOS

US Patents and Regulatory Information for ORTIKOS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929-001 Jun 13, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharma Global ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929-002 Jun 13, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sun Pharma Global ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929-001 Jun 13, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929-002 Jun 13, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ORTIKOS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom   Start Trial PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Boehringer Ingelheim
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McKesson
Baxter

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