FDA application holder
Janssen Biotech Inc
The Orange Book identifies this organization as the applicant responsible for NDA 219683.
Orange Book drug · Brand (NDA)
Inlexzo
Gemcitabine Hydrochloride
RLDNDA 219683 Janssen Biotech
Approved
Sep 09, 2025
Strengths
1
Listed patents
5
What does the FDA Orange Book show for Inlexzo?
Inlexzo contains Gemcitabine Hydrochloride and is the new drug FDA Orange Book record for NDA 219683. 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 219683
- Application holder
- Janssen Biotech Inc
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- None posted
- Listed patents
- 5
- Exclusivity records
- 1
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 | EQ 225MG BASE | SYSTEMINTRAVESICAL | Prescription | None posted | RLDRS |
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 prescription
RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.
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
5 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026
The latest future date recorded across those files is Aug 19, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.
Same-ingredient landscape
28 other ANDAs and 5 other NDAs found
16 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 219683 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
System · Intravesical
Gemcitabine Hydrochloride
- Product rows
- 1
- Active applications
- 1
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-219683
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 219683
RLDRS
- Strength
- EQ 225MG BASE
- Dosage form
- SYSTEM
- Route
- INTRAVESICAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
11 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
in 2 yr 2 mo
Patent 12403086 expires
Listed drug product patent expiration.
in 4 yr
Patent 12576253 expires
Listed drug product patent expiration.
in 4 yr 6 mo
Patent 8679094 expires
Listed drug product patent expiration.
in 5 yr 10 mo
Patent 10729823 expires
Listed drug product patent expiration.
in 8 yr 2 mo
Patent 12447241 expires
Listed drug product patent expiration.
in 8 yr 2 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
GEMCITABINE HYDROCHLORIDE
Strength
EQ 225MG BASE
Dosage form
SYSTEM
Route
INTRAVESICAL
TE code
Not listed
Application
NDA 219683
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Marketing exclusivity
Hatch-Waxman- NPNew product exclusivity (3 years)
in 2 yr 2 mo
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 12403086 | in 4 yr | Product | |
| 12576253 | in 4 yr 6 mo | Product | |
| 8679094 | in 5 yr 10 mo | Product | |
| 10729823 | in 8 yr 2 mo | Product | |
| 12447241 | in 8 yr 2 mo | Product |
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.
- 2025AvgemsiBrand (NDA)
NDA 219920 · Avyxa Holdings
- 2018InfugemBrand (NDA)
NDA 208313 · Sun Pharm
- 2017Gemcitabine HydrochlorideBrand (NDA)
NDA 209604 · Accord Hlthcare
- 2011Gemcitabine HydrochlorideBrand (NDA)
NDA 200795 · Hospira Inc
- 1996GemzarBrand (NDA)
NDA 020509 · Lilly
- 2023Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 213175 · Hikma
- 2021Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 206617 · Hikma Intl Pharms
- 2020Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 212129 · Meitheal
- 2019Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 210991 · Shilpa
- 2019Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 207575 · Shilpa
- 2019Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 210383 · Ingenus Pharms LLC
- 2018Gemcitabine HydrochlorideGeneric (ANDA)
ANDA 209077 · Sagent Pharms Inc
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.
Inlexzo: 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 219683 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.
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- 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.
