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LENVIMA

NDA

LENVATINIB MESYLATE | N206947 | EISAI INC

2 strengths10 unique patents3 unique exclusivities

Patent Timeline

10 unique patents, 2 exclusivities by expiration date

Expired (1)Expiring < 1yr (1)Active (8)TodayPED (+6 mo)Exclusivity

2025

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Apr. 24, 2026

Mar. 19, 2027

Jan. 27, 2028

Feb. 26, 2036

Feb. 26, 2036

Aug. 23, 2036

Feb. 26, 2036

Sep. 3, 2036

Nov. 15, 2038

Apr. 4, 2031

ODE-196

Feb. 15, 2026

M-14

Feb. 15, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
EISAI R&D MANAGEMENT CO., LTD. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 3:2019cv21857 2 patentsANDA 213092lenvatinib mesylate	D.N.J.	2019-12-23	Terminated 2020-03-23	—

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 Lenvima (2023)

Total Spending

$778.8M

Total Claims

32,513

Beneficiaries

7,904

Avg Cost/Unit

$492.97

Spending Trend

$272.5M(2019)→$367.8M(2020)→$452.1M(2021)→$626.0M(2022)→$778.8M(2023)

YoY Change:+10.4%

5yr CAGR:+9.6%

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

API Supply Chain11 active DMFs

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

DR REDDYS LABORATORIES LTDLENVATINIB MESYLATE (MIBK SOLVATE)

DMF 329052018

MSN LABORATORIES PRIVATE LTDLENVATINIB MESYLATE

DMF 330172018

SHILPA PHARMA LIFESCIENCES LTDLENVATINIB MESYLATE

DMF 330832018

MSN LABORATORIES PRIVATE LTDLENVATINIB

DMF 331952018

SUN PHARMACEUTICAL INDUSTRIES LTDLENVATINIB MESYLATE

DMF 333312019

OLON SPALENVATINIB MESYLATE

DMF 339642019

MSN LABORATORIES PRIVATE LTDLENVATINIB MESYLATE [ROUTE CODE JC]

DMF 357792021

DR REDDYS LABORATORIES LTDLENVATINIB MESYLATE (FORM-C)

DMF 360312021

OLON SPALENVATINIB MESYLATE FORM C

DMF 373472022

HETERO LABS LTDLENVATINIB MESYLATE

DMF 398872024

SICHUAN QINGMU PHARMACEUTICAL CO LTDLENVATINIB MESYLATE

DMF 414892025

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

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -33	View Letter (PDF)
Nov 21, 2024	SUPPL -32	View Letter (PDF)
Jul 2, 2024	SUPPL -31	View Letter (PDF)
Apr 4, 2024	SUPPL -30	View Letter (PDF)
Oct 24, 2023	SUPPL -28	View Letter (PDF)
Nov 14, 2022	SUPPL -24	View Letter (PDF)
Aug 8, 2022	SUPPL -25	View Letter (PDF)
May 16, 2022	SUPPL -21	View Letter (PDF)
Aug 11, 2021	SUPPL -19	View Letter (PDF)
Jul 22, 2021	SUPPL -20	View Letter (PDF)
Dec 22, 2020	SUPPL -18	View Letter (PDF)
Nov 12, 2020	SUPPL -16	View Letter (PDF)
Sep 16, 2020	SUPPL -17	View Letter (PDF)
May 1, 2020	SUPPL -13	View Letter (PDF)
Feb 21, 2020	SUPPL -12	View Letter (PDF)
Sep 18, 2019	SUPPL -11	View Letter (PDF)
Dec 20, 2018	SUPPL -9	View Letter (PDF)
Aug 16, 2018	SUPPL -7	View Letter (PDF)
Jun 14, 2018	SUPPL -8	View Letter (PDF)
Aug 2, 2017	SUPPL -5	View Letter (PDF)
May 16, 2016	SUPPL -3	View Letter (PDF)
Apr 26, 2016	SUPPL -4	View Letter (PDF)
Feb 17, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 4MG BASE

RLD

10 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Feb 13, 2015

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7253286	Oct 24, 2025PED: Apr 24, 2026	PED	Yes	Yes	—	—
7612208	Sep 19, 2026PED: Mar 19, 2027	PED	Yes	Yes	—	—
9006256	Jul 27, 2027PED: Jan 27, 2028	PED	—	—		—
10259791	Aug 26, 2035PED: Feb 26, 2036	PED	Yes	—	—	—
10407393	Aug 26, 2035PED: Feb 26, 2036	PED	Yes	—	—	—
11090386	Feb 23, 2036PED: Aug 23, 2036	PED	—	—		—
11186547	Aug 26, 2035PED: Feb 26, 2036	PED	Yes	—	—	—
12083112	Mar 3, 2036PED: Sep 3, 2036	PED	—	—		—
12226409	May 15, 2038PED: Nov 15, 2038	PED	—	—		—
12508313	Oct 4, 2030PED: Apr 4, 2031	PED	—	Yes	—	—

Exclusivities (3)

Code	Date	Status
M-14	Apr 3, 2027	< 1 year
ODE-196	Aug 15, 2025	Expired
PED	Feb 15, 2026	Expired

#002 — EQ 10MG BASE

RLD

10 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Feb 13, 2015