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SAXENDA

NDA

LIRAGLUTIDE | N206321 | NOVO NORDISK INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)TodayPED (+6 mo)IPRPTAB Challenge

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Today

8114833

Feb. 13, 2026IPR×3

9968659

Jul. 9, 2037

PTAB Proceedings

3 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-00657	8114833	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2022-03-03	2022-09-08
IPR2020-01252	8114833	IPR	Pfizer Inc.	Terminated-Settled	2020-07-22	—
IPR2020-00324	8114833	IPR	Pfizer Inc. et al.	Terminated-Settled	2019-12-19	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Novo Nordisk Inc. et al v. Orbicular Pharmaceutical Technologies Pvt. Ltd., et al., 1:2022cv00856 18 patentsANDA 217234liraglutide recombinant	D. Del.	2022-06-24	Terminated 2024-04-11	—
Novo Nordisk Inc. et al v. Teva Pharmaceuticals, Inc. et al 1:2021cv01782 17 patentsANDA 214568liraglutide recombinant	D. Del.	2021-12-21	Terminated 2023-09-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Saxenda (2023)

Total Spending

$34K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$88.40

Spending Trend

$29K(2021)→$34K(2023)

5yr CAGR:-0.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain18 active DMFs3 inactive

18 active API suppliers hold Drug Master Files for this ingredient.

CHENGDU SHENGNUO BIOPHARM CO LTDLIRAGLUTIDE

DMF 293022015

ALP PHARM BEIJING CO LTDLIRAGLUTIDE

DMF 297112015

HYBIO PHARMACEUTICAL CO LTDLIRAGLUTIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 300952015

BACHEM AGLIRAGLUTIDE DRUG SUBSTANCE

DMF 304672016

BACHEM AMERICAS INCLIRAGLUTIDE

DMF 333662020

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDLIRAGLUTIDE

DMF 341042019

SHENZHEN JYMED TECHNOLOGY CO LTDLIRAGLUTIDE

DMF 341712019

DR REDDYS LABORATORIES LTDLIRAGLUTIDE

DMF 347552020

FRESENIUS KABI IPSUM SRLLIRAGLUTIDE

DMF 352422022

HANGZHOU JIUYUAN GENE ENGINEERING CO LTDLIRAGLUTIDE

DMF 353492021

POLYPEPTIDE LABORATORIES INCLIRAGLUTIDE

DMF 358602021

BIOCON LTDLIRAGLUTIDE

DMF 359682021

ZHEJIANG PEPTITES BIOTECH CO LTDLIRAGLUTIDE

DMF 359722021

SUN PHARMACEUTICAL INDUSTRIES LTDLIRAGLUTIDE

DMF 365492021

SCINOPHARM TAIWAN LTDLIRAGLUTIDE

DMF 370092022

AURO PEPTIDES LTDLIRAGLUTIDE

DMF 377932023

CHONGQING CHEN'AN BIOPHARMACEUTICAL CO LTDLIRAGLUTIDE

DMF 386812023

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDLIRAGLUTIDE

DMF 390922023

CHENGDU SHENGNUO BIOPHARM CO LTDInactiveLIRAGLUTIDE

DMF 285132014

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDInactiveLIRAGLUTIDE

DMF 330962018

AMPHASTAR NANJING PHARMACEUTICALS INCInactiveLIRAGLUTIDE

DMF 339122019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Jun 3, 2026	SUPPL -24	View Letter (PDF)
Feb 27, 2026	SUPPL -25	View Letter (PDF)
Oct 15, 2025	SUPPL -22	View Letter (PDF)
May 29, 2025	SUPPL -20	View Letter (PDF)
Nov 5, 2024	SUPPL -19	View Letter (PDF)
Apr 21, 2023	SUPPL -16	View Letter (PDF)
Jun 16, 2022	SUPPL -15	View Letter (PDF)
Dec 8, 2020	SUPPL -12	View Letter (PDF)
Dec 8, 2020	SUPPL -13	View Letter (PDF)
Dec 8, 2020	SUPPL -14	View Letter (PDF)
Mar 26, 2020	SUPPL -11	View Letter (PDF)
Dec 7, 2018	SUPPL -9	View Letter (PDF)
Oct 23, 2018	SUPPL -7	View Letter (PDF)
Jun 1, 2017	SUPPL -5	View Letter (PDF)
May 2, 2017	SUPPL -4	View Letter (PDF)
May 2, 2017	SUPPL -6	View Letter (PDF)
Oct 12, 2016	SUPPL -3	View Letter (PDF)
Feb 2, 2016	SUPPL -2	View Letter (PDF)
Mar 31, 2015	SUPPL -1	View Letter (PDF)
Dec 31, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 18MG/3ML (6MG/ML)

RLDAP2

2 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 23, 2014

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8114833	Aug 13, 2025PED: Feb 13, 2026	PED	—	Yes	—	—
9968659	Jan 9, 2037PED: Jul 9, 2037	PED	—	—		—