FDA application holder
Kaleo Inc
The Orange Book identifies this organization as the applicant responsible for NDA 205787.
Orange Book drug · Brand (NDA)
Evzio
Naloxone Hydrochloride
DiscontinuedRLDNDA 205787 Kaleo Inc
Approved
Apr 03, 2014
Strengths
1
Listed patents
21
What does the FDA Orange Book show for Evzio?
Evzio contains Naloxone Hydrochloride and is the new drug FDA Orange Book record for NDA 205787. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.
- FDA application
- NDA 205787
- Application holder
- Kaleo Inc
- Product presentations
- 1
- Marketing categories
- Discontinued
- Reference roles
- RLD
- TE codes
- None posted
- Listed patents
- 21
- Exclusivity records
- 0
New drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
FDA product-presentation matrix
Every product number in this exact application
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 0.4MG/0.4ML (0.4MG/0.4ML) | SOLUTIONINTRAMUSCULAR, SUBCUTANEOUS | Discontinued | None posted | RLD |
Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.
Who is responsible for this application?
Application holder is not the same as manufacturer
Manufacturer status
Not established by the Orange Book
A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.
Regulatory interpretation
What the record means, and what it does not
FDA marketing status
1 presentation listed as on the Discontinued Drug Product List
A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.
Therapeutic equivalence
No TE code is posted for this application
No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.
Patent & exclusivity record
17 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026
The latest future date recorded across those files is Mar 20, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.
Same-ingredient landscape
76 other ANDAs and 9 other NDAs found
27 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.
Which products are meaningfully comparable?
Exact ingredient + dosage form + route cohorts
NDA 205787 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Solution · Intramuscular, Subcutaneous
Naloxone Hydrochloride
- Product rows
- 4
- Active applications
- 1
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-205787
No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.
Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.
Product detail
NDA 205787
RLDDiscontinued
- Strength
- 0.4MG/0.4ML (0.4MG/0.4ML)
- Dosage form
- SOLUTION
- Route
- INTRAMUSCULAR, SUBCUTANEOUS
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
12 yr 6 mo ago
Patent 9278182 expires
Listed drug product patent expiration.
6 mo ago
Patent 8926594 expires
Listed drug product patent expiration.
4 mo ago
Patent 7731686 expires
Listed drug product patent expiration.
2 mo ago
Patent 10960155 expires
Listed drug product patent expiration.
1 mo ago
Today
Patent 11590286 expires
Listed drug product patent expiration.
in 5 mo
Patent 9238108 expires
Listed drug product patent expiration.
in 7 mo
Patent 8206360 expires
Listed drug product patent expiration.
in 7 mo
Patent 9724471 expires
Listed drug product patent expiration.
in 10 mo
Patent 7947017 expires
Listed drug product patent expiration.
in 1 yr 8 mo
Patent 7749194 expires
Listed drug product patent expiration.
in 2 yr 4 mo
Patent 8231573 expires
Listed drug product patent expiration.
in 2 yr 4 mo
Patent 8226610 expires
Listed drug product patent expiration.
in 2 yr 9 mo
Patent 8021344 expires
Listed drug product patent expiration.
in 3 yr 4 mo
Patent 10322239 expires
Listed method-of-use patent (U-1907) expiration.
in 4 yr 8 mo
Patent 8939943 expires
Listed drug product patent expiration.
in 4 yr 8 mo
Patent 9022022 expires
Listed drug product patent expiration.
in 4 yr 8 mo
Patent 9474869 expires
Listed drug product patent expiration.
in 4 yr 8 mo
Patent 10143972 expires
Listed method-of-use patent (U-2476) expiration.
in 4 yr 11 mo
Patent 8627816 expires
Listed drug product patent expiration.
in 5 yr 7 mo
Patent 9517307 expires
Listed drug product patent expiration.
in 8 yr 1 mo
Patent 10220158 expires
Listed drug product patent expiration.
in 8 yr 9 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
NALOXONE HYDROCHLORIDE
Strength
0.4MG/0.4ML (0.4MG/0.4ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR, SUBCUTANEOUS
TE code
Not listed
Application
NDA 205787
Product number
001
Marketing status
Discontinued
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 9278182 | 6 mo ago | Product | |
| 8926594 | 4 mo ago | Product | |
| 7731686 | 2 mo ago | Product | |
| 10960155 | 1 mo ago | Product | |
| 11590286 | in 5 mo | Product | |
| 9238108 | in 7 mo | Product | |
| 8206360 | in 7 mo | Product | |
| 9724471 | in 10 mo | ProductU-2092 | |
| 7947017 | in 1 yr 8 mo | Product | |
| 7749194 | in 2 yr 4 mo | Product | |
| 8231573 | in 2 yr 4 mo | Product | |
| 8226610 | in 2 yr 9 mo | Product | |
| 8021344 | in 3 yr 4 mo | Product | |
| 10322239 | in 4 yr 8 mo | U-1907 | |
| 8939943 | in 4 yr 8 mo | Product | |
| 9022022 | in 4 yr 8 mo | Product | |
| 9474869 | in 4 yr 8 mo | ProductU-1907 | |
| 10143972 | in 4 yr 11 mo | U-2476 | |
| 8627816 | in 5 yr 7 mo | Product | |
| 9517307 | in 8 yr 1 mo | ProductU-1925 | |
| 10220158 | in 8 yr 9 mo | ProductU-2500 |
Active-ingredient family
Brand + generics
This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025KloxxadoBrand (NDA)
NDA 212045 · Hikma
- 2024RezenopyBrand (NDA)
NDA 215487 · Scienture
- 2023RiviveBrand (NDA)
NDA 217722 · Harm Reduction Therp
- 2023RextovyBrand (NDA)
NDA 208969 · Amphastar Pharms Inc
- 2022Naloxone Hydrochloride (autoinjector)Brand (NDA)
NDA 215457 · Kaleo Inc
- 2021ZimhiBrand (NDA)
NDA 212854 · Zmi Pharma
- 2017NarcanBrand (NDA)
NDA 208411 · Emergent
- 2016Evzio (autoinjector)Brand (NDA)
NDA 209862 · Kaleo Inc
- —NarcanBrand (NDA)
NDA 016636 · Adapt
- 2025Naloxone HydrochlorideGeneric (ANDA)
ANDA 214211 · Sterinova Inc
- 2025Naloxone HydrochlorideGeneric (ANDA)
ANDA 216719 · Padagis Israel
- 2024Naloxone HydrochlorideGeneric (ANDA)
ANDA 217992 · Amneal
How to use this record responsibly
Scope, limitations, and primary sources
What to verify before making a decision
- The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
- RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
- Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
- Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
- The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.
Official FDA references
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.
Evzio: frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.
Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 205787 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- 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.
