BLA number
761109
FDA Purple Book product · 351(a) biologic
Lyumjev
insulin lispro-aabc
Lyumjev, BLA 761109, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 6 exact FDA presentation rows, and no exact reference-product relationship is asserted. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(a)BLA 761109 6 presentationsRxLicensed Eli Lilly and Company
Approved
Jun 15, 2020
License type
351(a)
Marketing
Rx
Listed patents
0
Lyumjev (insulin lispro-aabc) is Eli Lilly and Company's FDA-licensed 351(a) biologic under BLA 761109, approved in 2020. No 351(k) product in the loaded Purple Book family data explicitly references Lyumjev; that bounded result is not a claim about future reference-product eligibility.
Sourced from the FDA Purple Book · verified Jul 02, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(a) biologic
Applicant
Eli Lilly and Company
Applicant is not automatically the physical manufacturer.
Presentations
6
Exact FDA presentation rows under this BLA.
Approval
Jun 15, 2020
Reference product
Not stated
Lyumjev is an FDA-licensed 351(a) biologic.
No 351(k) product in the loaded Purple Book family data explicitly references Lyumjev.
Substitution boundary
The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Jun 15, 2020
6 yr 2 mo ago
Today
Strengths & presentations
6 FDA presentation rows · BLA 761109
Strength
1,000UNITS/10ML (100UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
1891
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1891
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1891
Product number
003
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1891
Product number
004
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Multi-Dose Cartridge
Center
CDER
License number
1891
Product number
005
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
600UNITS/3ML (200UNITS/ML)
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
1891
Product number
006
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Exact presentation matrix
One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Licensed | Rx |
| 002 | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Licensed | Disc |
| 003 | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Licensed | Rx |
| 004 | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Licensed | Rx |
| 005 | 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Cartridge | Licensed | Disc |
| 006 | 600UNITS/3ML (200UNITS/ML) | Injection | Intravenous, Subcutaneous | Autoinjector | Licensed | Rx |
Exact-source evidence coverage
Labeling & approval review
Current product label
Candidate awaiting exact-BLA match
FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.
Inspect FDA label candidateFDA approval evidence
Not applicable to 351(a)
A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
The current record does not expose a reference-product name or an exact linked 351(k) family for Lyumjev.
No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.
Published patents
BPCIA patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Practical characteristics and limits
Source-bounded interpretation
Presentation coverage
6 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Intravenous, Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
Eli Lilly and Company is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.
Regulatory comparison
Lyumjev is an FDA-licensed 351(a) biologic. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.
Source provenance
FDA Purple Book data
Source kind · Advanced Search
Checked Jul 02, 2026- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
What this record does not establish
- Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
- The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
- Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
- A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
- Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.
Change history
Record versions
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Lyumjev: frequently asked questions
Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.
Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
