Purple Book product · Interchangeable

Hadlima

adalimumab-bwwd

351(k) InterchangeableBLA 761059RxLicensed Samsung Bioepis Co., Ltd.

View adalimumab family Label PDF Open on FDA Purple Book

Aug 15, 2022

Approved

Interchangeable

License type

Marketing

Listed patents

Hadlima (adalimumab-bwwd) is a Interchangeable referencing adalimumab, licensed under a 351(k) BLA in 2022 and marketed by Samsung Bioepis Co., Ltd.. As an interchangeable biosimilar it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law. The Purple Book lists 66 published patents for this product.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Aug 15, 2022
4 yr ago
Today

Pharmaceutical detail

Strength

40MG/0.4ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

2046

Product number

004

Submission type

Supplement

Supplement number

Change type

Not listed

Reference product family

View full family

Biosimilar of adalimumab (Humira)

Patent list (66)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
8,911,737	Jun 05, 2022	4 yr 2 mo ago	FDA
8,974,790	Jun 05, 2022	4 yr 2 mo ago	FDA
8,992,926	Jun 05, 2022	4 yr 2 mo ago	FDA
9,546,212	Jun 05, 2022	4 yr 2 mo ago	FDA
6,805,686	May 06, 2023	3 yr 3 mo ago	FDA
8,906,373	Jul 18, 2023	3 yr 1 mo ago	FDA
9,067,992	Jul 18, 2023	3 yr 1 mo ago	FDA
9,085,620	Jul 18, 2023	3 yr 1 mo ago	FDA
9,090,689	Jul 18, 2023	3 yr 1 mo ago	FDA
8,961,973	Apr 11, 2025	1 yr 3 mo ago	FDA
8,961,974	Apr 11, 2025	1 yr 3 mo ago	FDA
8,986,693	Apr 11, 2025	1 yr 3 mo ago	FDA
9,061,005	Apr 11, 2025	1 yr 3 mo ago	FDA
9,187,559	Apr 11, 2025	1 yr 3 mo ago	FDA
9,512,216	Apr 11, 2025	1 yr 3 mo ago	FDA
8,808,700	May 16, 2026	2 mo ago	FDA
11,083,792	Apr 04, 2027	in 9 mo	FDA
8,231,876	Apr 04, 2027	in 9 mo	FDA
8,883,156	Apr 04, 2027	in 9 mo	FDA
8,895,009	Apr 04, 2027	in 9 mo	FDA
8,906,372	Apr 04, 2027	in 9 mo	FDA
8,916,153	Apr 04, 2027	in 9 mo	FDA
9,096,666	Apr 04, 2027	in 9 mo	FDA
9,102,723	Apr 04, 2027	in 9 mo	FDA
9,273,132	Apr 04, 2027	in 9 mo	FDA
9,328,165	Apr 04, 2027	in 9 mo	FDA
9,913,902	Apr 04, 2027	in 9 mo	FDA
8,926,975	Jun 08, 2027	in 11 mo	FDA
8,715,664	Jul 24, 2027	in 1 yr	FDA
8,663,945	Sep 13, 2027	in 1 yr 2 mo	FDA
8,906,646	Sep 13, 2027	in 1 yr 2 mo	FDA
8,911,964	Sep 13, 2027	in 1 yr 2 mo	FDA
9,090,867	Sep 13, 2027	in 1 yr 2 mo	FDA
9,234,032	Sep 13, 2027	in 1 yr 2 mo	FDA
9,284,371	Sep 13, 2027	in 1 yr 2 mo	FDA
8,889,136	Oct 09, 2027	in 1 yr 3 mo	FDA
9,284,370	Jun 10, 2028	in 1 yr 11 mo	FDA
9,669,093	Jun 10, 2028	in 1 yr 11 mo	FDA
11,167,030	Nov 28, 2028	in 2 yr 5 mo	FDA
11,191,834	Nov 28, 2028	in 2 yr 5 mo	FDA
9,085,619	Nov 28, 2028	in 2 yr 5 mo	FDA
8,420,081	Jan 13, 2030	in 3 yr 6 mo	FDA
8,999,337	Feb 06, 2031	in 4 yr 7 mo	FDA
9,624,295	Mar 31, 2031	in 4 yr 9 mo	FDA
8,708,968	Jan 24, 2032	in 5 yr 7 mo	FDA
9,339,610	Jan 24, 2032	in 5 yr 7 mo	FDA
9,062,106	Apr 26, 2032	in 5 yr 10 mo	FDA
9,090,688	Apr 26, 2032	in 5 yr 10 mo	FDA
9,505,834	Apr 26, 2032	in 5 yr 10 mo	FDA
9,522,953	Apr 26, 2032	in 5 yr 10 mo	FDA
9,683,033	Apr 26, 2032	in 5 yr 10 mo	FDA
9,957,318	Apr 26, 2032	in 5 yr 10 mo	FDA
9,085,618	Mar 14, 2033	in 6 yr 9 mo	FDA
9,181,337	Mar 14, 2033	in 6 yr 9 mo	FDA
9,181,572	Mar 14, 2033	in 6 yr 9 mo	FDA
9,290,568	Mar 14, 2033	in 6 yr 9 mo	FDA
9,334,319	Mar 14, 2033	in 6 yr 9 mo	FDA
9,346,879	Mar 14, 2033	in 6 yr 9 mo	FDA
9,359,434	Mar 14, 2033	in 6 yr 9 mo	FDA
9,499,616	Mar 14, 2033	in 6 yr 9 mo	FDA
9,708,400	Mar 14, 2033	in 6 yr 9 mo	FDA
9,315,574	Apr 21, 2033	in 6 yr 10 mo	FDA
9,150,645	May 13, 2033	in 6 yr 11 mo	FDA
9,266,949	May 13, 2033	in 6 yr 11 mo	FDA
9,499,614	Mar 14, 2034	in 7 yr 9 mo	FDA
9,550,826	Nov 14, 2034	in 8 yr 5 mo	FDA

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Hadlima's patents expire?

The FDA Purple Book lists 66 published patents for Hadlima, with the last listed patent expiring Nov 14, 2034. Every patent below links to its FDA source record so you can verify the expiration date.

Is Hadlima a biosimilar?

Yes. Hadlima is a Interchangeable referencing adalimumab, licensed under a 351(k) BLA.

Is Hadlima interchangeable?

Yes. Hadlima carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

What is Hadlima's BLA number?

Hadlima is licensed under BLA 761059, held by Samsung Bioepis Co., Ltd..

When was Hadlima approved by the FDA?

Hadlima was approved by the FDA on Aug 15, 2022.

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