`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` APPROVED
`
` DRUG
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
` EQUIVALENCE
`
` EVALUATIONS
` 44th EDITION
`
`
`
`
`
`
`
`
`
`
`
` THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
`
`
`
`
` SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
`
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
` FOOD AND DRUG ADMINISTRATION
` OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`
`
` CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
` OFFICE OF GENERIC DRUGS
` OFFICE OF GENERIC DRUG POLICY
`
`
`
`
`
`
` 2024
`
`
`
`MPI EXHIBIT 1101 PAGE 1
`
`MPI EXHIBIT 1101 PAGE 1
`
`
`
` APPROVED DRUG PRODUCTS
`
`
`
` with
` THERAPEUTIC EQUIVALENCE EVALUATIONS
`
`
`
`
`
`
`
`
`
`
`
`
` The products in this list have been approved under section 505 of the
` Federal Food, Drug, and Cosmetic Act. This volume is current through
`
`
`
` December 31, 2023.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 44th EDITION
`
`
`
`
`
`
`
` U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
` FOOD AND DRUG ADMINISTRATION
` OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`
`
`
` CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
` OFFICE OF GENERIC DRUGS
` OFFICE OF GENERIC DRUG POLICY
`
`
`
`
`
` 2024
`
`
`
`
`
`
`
`
`
`
`
`
`
`MPI EXHIBIT 1101 PAGE 2
`
`MPI EXHIBIT 1101 PAGE 2
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 374 of 442
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`APPL/PROD
`PATENT
`PATENT
`NO
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT NO
`
`PATENT
`CODES
`
`SELPERCATINIB - RETEVMO
`N 213246 002 10172851
`10172851
`10172851
`10584124
`10584124
`10584124
`10584124
`10584124
`10584124
`10584124
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`
`SELUMETINIB SULFATE - KOSELUGO
`N 213756 001 11813246
`7425637
`9156795
`9562017
`
`SELUMETINIB SULFATE - KOSELUGO
`N 213756 002 11813246
`7425637
`9156795
`9562017
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 001 10220155
`10335462
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`
`Oct 10, 2037
`Oct 10, 2037
`Oct 10, 2037
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`
`Mar 26, 2029
`Mar 13, 2024
`Dec 12, 2026
`Dec 12, 2026
`
`Mar 26, 2029
`Mar 13, 2024
`Dec 12, 2026
`Dec 12, 2026
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 27, 2027
`
`DS
`DS
`DS
`DS
`DS
`DS
`DS
`
`U-2826
`U-2827
`U-2828
`U-2826
`U-2827
`U-2828
`U-3450
`U-3451
`U-3452
`U-3453
`DP U-2971
`DP U-2972
`DP U-2973
`DP U-2974
`DP U-2975
`DP U-2976
`DP U-2977
`DP U-3450
`DP U-3451
`DP U-3452
`DP U-3453
`
`DP
`
`DS
`DS DP
`DS
`
`DP
`
`DS
`DS DP
`DS
`
`U-2800
`
`U-2800
`
`DP
`
`U-2580
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2202
`DS DP U-2202
`DP
`DP
`DP
`DP
`DP
`
`NCE
`ODE-288
`
`Apr 10, 2025
`Apr 10, 2027
`
`NCE
`ODE-288
`
`Apr 10, 2025
`Apr 10, 2027
`
`MPI EXHIBIT 1101 PAGE 3
`
`MPI EXHIBIT 1101 PAGE 3
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 375 of 442
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`APPL/PROD
`PATENT
`PATENT
`NO
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT NO
`
`PATENT
`CODES
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 001 9616180
`9687611
`9775953
`9861757
`RE46363
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 002 10220155
`10335462
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`9616180
`9687611
`9775953
`9861757
`RE46363
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 003 10220155
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`9616180
`9687611
`9775953
`9861757
`RE46363
`
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 29, 2027
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Jul 17, 2026
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 29, 2027
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`DP
`DP
`DP
`DP
`DP
`
`DP
`
`U-2580
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2202
`DS DP U-2202
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-3355
`DS DP U-3355
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`D-185
`
`Mar 28, 2025
`
`MPI EXHIBIT 1101 PAGE 4
`
`MPI EXHIBIT 1101 PAGE 4
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 376 of 442
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`APPL/PROD
`PATENT
`PATENT
`NO
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT NO
`
`PATENT
`CODES
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 004 10220155
`10335462
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`9616180
`9687611
`9775953
`9861757
`RE46363
`
`SEMAGLUTIDE - RYBELSUS
`N 213051 001 10086047
`10278923
`10933120
`10960052
`11382957
`11759501
`11759502
`11759503
`8129343
`8536122
`9278123
`
`SEMAGLUTIDE - RYBELSUS
`N 213051 002 10086047
`10278923
`10933120
`10960052
`11382957
`11759501
`11759502
`11759503
`8129343
`8536122
`9278123
`
`SEMAGLUTIDE - RYBELSUS
`N 213051 003 10086047
`10278923
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 29, 2027
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Dec 16, 2031
`May 02, 2034
`Mar 15, 2033
`Dec 16, 2031
`Dec 16, 2031
`Mar 15, 2033
`Mar 15, 2033
`Mar 15, 2033
`Dec 05, 2031
`Mar 20, 2026
`Dec 16, 2031
`
`Dec 16, 2031
`May 02, 2034
`Mar 15, 2033
`Dec 16, 2031
`Dec 16, 2031
`Mar 15, 2033
`Mar 15, 2033
`Mar 15, 2033
`Dec 05, 2031
`Mar 20, 2026
`Dec 16, 2031
`
`DP
`DP U-2580
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-3469
`DS DP U-3469
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`
`U-2628
`
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`DP
`
`U-2628
`
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`Dec 16, 2031
`May 02, 2034
`
`DP
`
`U-2628
`
`MPI EXHIBIT 1101 PAGE 5
`
`MPI EXHIBIT 1101 PAGE 5
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
