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MYFEMBREE

NDA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | N214846 | SUMITOMO PHARMA AMERICA INC

1 strength8 unique patents1 unique exclusivity

Patent Timeline

8 unique patents, 1 exclusivity by expiration date

Expired (1)Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Jan. 28, 2029

Jan. 28, 2026

Sep. 29, 2037

May. 3, 2038

Sep. 27, 2033

Sep. 29, 2037

Sep. 27, 2033

Nov. 5, 2042

M-289

Jan. 27, 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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Sumitomo Pharma Switzerland GmbH et al v. Annora Pharma Private Limited et al 1:2025cv00380 4 patentsANDA 220123relugolix, estradiol, norethindrone acetate	D. Del.	2025-03-27	Active	—

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 Myfembree (2023)

Total Spending

$1.7M

Total Claims

1,153

Beneficiaries

330

Avg Cost/Unit

$41.67

Spending Trend

$58K(2021)→$616K(2022)→$1.7M(2023)

YoY Change:+5.8%

5yr CAGR:+6.7%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 29, 2025	SUPPL -12	View Letter (PDF)
Jul 18, 2024	SUPPL -8	View Letter (PDF)
May 2, 2024	SUPPL -7	View Letter (PDF)
Jan 30, 2023	SUPPL -5	View Letter (PDF)
Jan 30, 2023	SUPPL -6	View Letter (PDF)
Aug 8, 2022	SUPPL -2	View Letter (PDF)
May 27, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG;0.5MG;40MG

RLD

8 patents1 exclusivity▴

TABLET;ORAL | Approved: May 26, 2021

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7300935	Jan 28, 2029	—	Yes	—	—	—
8058280	Jan 28, 2026	—	Yes	Yes	—	—
11033551	Sep 29, 2037	—	—	—		—
11793812	May 3, 2038	—	—	—		—
11795178	Sep 27, 2033	—	Yes	Yes	—	—
11957684	Sep 29, 2037	—	—	—		—
12325714	Sep 27, 2033	—	Yes	Yes	—	—
12551447	Nov 5, 2042	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-289	Jan 27, 2026	Expired