Steglujan is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 10 US drug patents filed from 2018 to 2021. Out of these, 5 drug patents are active and 5 have expired. Steglujan's patents have been open to challenges since 19 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 21, 2030. Details of Steglujan's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8080580 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives |
Jul, 2030
(4 years from now) | Active |
| US7326708 | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor |
Nov, 2026
(1 year, 21 days from now) | Active |
| US6699871 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jul, 2022
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9308204 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives |
Oct, 2030
(4 years from now) | Active |
| US9439901 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives |
Oct, 2030
(4 years from now) | Active |
|
US7326708 (Pediatric) | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor |
May, 2027
(1 year, 6 months from now) | Active |
|
US6699871 (Pediatric) | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jan, 2023
(2 years ago) |
Expired
|
| US6890898 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(6 years ago) |
Expired
|
| US7078381 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(6 years ago) |
Expired
|
| US7459428 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Steglujan's patents.
Latest Legal Activities on Steglujan's Patents
Given below is the list of recent legal activities going on the following patents of Steglujan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 27 Jun, 2024 | US8080580 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2023 | US8080580 |
| Second letter to regulating agency to determine regulatory review period | 22 Apr, 2021 | US8080580 |
| Second letter to regulating agency to determine regulatory review period | 15 Apr, 2021 | US8080580 |
| Letter from FDA or Dept of Agriculture re PTE application | 12 Jun, 2019 | US8080580 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 May, 2019 | US8080580 |
| Initial letter Re: PTE Application to regulating agency | 15 Oct, 2018 | US8080580 |
| Patent Term Extension Application under 35 USC 156 Filed | 15 Feb, 2018 | US8080580 |
| Recordation of Patent Grant Mailed
Critical | 20 Dec, 2011 | US8080580 |
| Patent Issue Date Used in PTA Calculation
Critical | 20 Dec, 2011 | US8080580 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Steglujan and ongoing
litigations to
help you estimate the early arrival of Steglujan generic.
Steglujan's Litigations
Steglujan been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 10, 2020, against patent number US7326708. The petitioner Teva Pharmaceuticals USA, Inc., challenged the validity of this patent, with Merck Sharp & Dohme Corp. as the respondent. Click below to track the latest information on how companies are challenging Steglujan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7326708 | June, 2020 |
Final Written Decision
(10 May, 2021) | Merck Sharp & Dohme Corp. et al. | Dr. Reddy's Laboratories, Inc. et al. |
| US7326708 | June, 2020 |
Final Written Decision
(10 May, 2021) | Merck Sharp & Dohme Corp. et al. | Sun Pharmaceutical Industries Ltd. et al. |
| US7326708 | October, 2019 |
Final Written Decision
(07 May, 2021) | Merck Sharp & Dohme Corp. et al. | Mylan Pharmaceuticals, Inc. |
| US7326708 | June, 2020 |
Terminated-Settled
(08 Dec, 2020) | Merck Sharp & Dohme Corp. | Teva Pharmaceuticals USA, Inc. |
FDA has granted some exclusivities to Steglujan. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Steglujan,
regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying
the generic
launch. Given below are details of the exclusivities granted to
Steglujan.
Exclusivity Information
Steglujan holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Steglujan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2022 |
| M(M-275) | Sep 17, 2024 |
Several oppositions have been filed on Steglujan's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Steglujan's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Steglujan patents.
Steglujan's Oppositions Filed in EPO
Steglujan has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 11, 2008, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP04755691A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP05077584A | Mar, 2011 | APOTEX INC. | Revoked |
| EP04755691A | Jun, 2008 | Teva Pharmaceutical Industries Ltd. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Steglujan is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Steglujan's family patents as well as insights into
ongoing legal events
on those patents.
Steglujan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Steglujan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 21, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Steglujan Generics:
There are no approved generic versions for Steglujan as of now.
Alternative Brands for Steglujan
Steglujan which is used for improving glycemic control in adults with type 2 diabetes., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Msd Sub Merck |
| |||||
| Theracosbio |
| |||||
About Steglujan
Steglujan is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for improving glycemic control in adults with type 2 diabetes. Steglujan uses Ertugliflozin; Sitagliptin Phosphate as an active ingredient. Steglujan was launched by Msd Sub Merck in 2017.
Approval Date:
Steglujan was approved by FDA for market use on 19 December, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Steglujan is 19 December, 2017, its NCE-1 date is estimated to be 19 December, 2021.
Active Ingredient:
Steglujan uses Ertugliflozin; Sitagliptin Phosphate as the active ingredient. Check out other Drugs and Companies using Ertugliflozin; Sitagliptin Phosphate ingredient
Treatment:
Steglujan is used for improving glycemic control in adults with type 2 diabetes.
Dosage:
Steglujan is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;EQ 100MG BASE | TABLET | Prescription | ORAL |
| 15MG;EQ 100MG BASE | TABLET | Prescription | ORAL |