FDA Orange Book
Is there a generic for BYNFEZIA Pen?
BYNFEZIA Pen contains octreotide acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for BYNFEZIA Pen (octreotide acetate). The Orange Book shows its last listed patent expires December 29, 2041.
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BYNFEZIA Pen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 213224, held by SUN PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
BYNFEZIA Pen patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10342850 | May 15, 2038 | Drug product | None | 213224 |
| 11246991 | November 3, 2040 | Method of use | U-4007 | 213224 |
| 11246991 | November 3, 2040 | Method of use | U-4008 | 213224 |
| 11246991 | November 3, 2040 | Method of use | U-4009 | 213224 |
| 11534553 | November 3, 2040 | Method of use | U-4007 | 213224 |
| 11534553 | November 3, 2040 | Method of use | U-4008 | 213224 |
| 11534553 | November 3, 2040 | Method of use | U-4009 | 213224 |
| 11052196 | November 3, 2040 | Method of use | U-4007 | 213224 |
| 11052196 | November 3, 2040 | Method of use | U-4008 | 213224 |
| 11052196 | November 3, 2040 | Method of use | U-4009 | 213224 |
| 12350475 | December 29, 2041 | Method of use | U-4007 | 213224 |
| 12350475 | December 29, 2041 | Method of use | U-4008 | 213224 |
| 12350475 | December 29, 2041 | Method of use | U-4009 | 213224 |
BYNFEZIA Pen NDC codes
Questions
Is there a generic for BYNFEZIA Pen?
No. The Orange Book lists no active FDA-approved generic (ANDA) for BYNFEZIA Pen (octreotide acetate). The Orange Book shows its last listed patent expires December 29, 2041.
What is the generic name for BYNFEZIA Pen?
The active ingredient in BYNFEZIA Pen is octreotide acetate, per the FDA Orange Book.
When does the BYNFEZIA Pen patent expire?
The last patent listed for BYNFEZIA Pen in the Orange Book expires December 29, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on BYNFEZIA Pen and Octreotide Acetate
- What is Octreotide Acetate used for?FDA label uses
- Is Octreotide Acetate a controlled substance?Federal schedule
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- NDC 62756-452BYNFEZIA Pen NDC record