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Last Updated: September 23, 2021

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STEGLATRO Drug Patent Profile


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When do Steglatro patents expire, and when can generic versions of Steglatro launch?

Steglatro is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug.

This drug has fifty-nine patent family members in forty-eight countries.

The generic ingredient in STEGLATRO is ertugliflozin. One supplier is listed for this compound. Additional details are available on the ertugliflozin profile page.

DrugPatentWatch® Generic Entry Outlook for Steglatro

Steglatro will be eligible for patent challenges on December 19, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for STEGLATRO
International Patents:59
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 53
Clinical Trials: 4
Patent Applications: 236
Drug Prices: Drug price information for STEGLATRO
What excipients (inactive ingredients) are in STEGLATRO?STEGLATRO excipients list
DailyMed Link:STEGLATRO at DailyMed
Drug patent expirations by year for STEGLATRO
Drug Prices for STEGLATRO

See drug prices for STEGLATRO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for STEGLATRO
Generic Entry Date for STEGLATRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for STEGLATRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical University InnsbruckPhase 3
Elisabethinen HospitalPhase 3
Wilhelminenspital ViennaPhase 3

See all STEGLATRO clinical trials

US Patents and Regulatory Information for STEGLATRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-002 Dec 19, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-002 Dec 19, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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 STEGLATRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 300943 Netherlands ⤷  Try it Free PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687 PA2018510 Lithuania ⤷  Try it Free PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687 CA 2018 00025 Denmark ⤷  Try it Free PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323
2334687 2018/028 Ireland ⤷  Try it Free PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
McKinsey
Harvard Business School
Boehringer Ingelheim
Dow

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.