FDA application holder
Genentech Inc
The Orange Book identifies this organization as the applicant responsible for NDA 212725.
Orange Book drug · Brand (NDA)
Rozlytrek
Entrectinib
RLDNDA 212725 2 strengths Genentech Inc
Approved
Aug 15, 2019
Strengths
2
Listed patents
14
Applications
2
What does the FDA Orange Book show for Rozlytrek?
Rozlytrek contains Entrectinib and appears in 2 FDA Orange Book applications. NDA 212725 is the lead filing, with 2 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.
- FDA applications
- 2; lead NDA 212725
- Lead application holder
- Genentech Inc
- Product presentations
- 2
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- None posted
- Listed patents
- 14
- Exclusivity records
- 4
Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.
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 | 100MG | CAPSULEORAL | Prescription | None posted | RLD |
| 002 | 200MG | CAPSULEORAL | 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
2 presentations 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
14 listed patent expirations and 4 exclusivity dates remain on or after Jul 26, 2026
The latest future date recorded across those files is Jul 18, 2038. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.
Same-ingredient landscape
0 other ANDAs and 0 other NDAs found
0 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 212725 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Capsule · Oral
Entrectinib
- Product rows
- 2
- Active applications
- 1
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-212725
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.
Strengths & dosage forms
2 approved presentations · NDA 212725
RLD
- Strength
- 100MG
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
7 yr 1 mo ago
Today
Exclusivity ends · ODE-265
Orphan-drug exclusivity (7 years)
in 20 d
Exclusivity ends · ODE-313
Orphan-drug exclusivity (7 years)
in 20 d
Exclusivity ends · NPP
New patient population exclusivity (3 years)
in 3 mo
Patent 8673893 expires
Listed method-of-use patent (U-2618) expiration.
in 2 yr
Patent 8673893 expires
Listed method-of-use patent (U-2617) expiration.
in 2 yr
Patent 9029356 expires
Listed drug substance patent expiration.
in 2 yr
Patent 9085558 expires
Listed drug product patent expiration.
in 2 yr
Patent 9255087 expires
Listed method-of-use patent (U-2618) expiration.
in 2 yr
Patent 9255087 expires
Listed method-of-use patent (U-2617) expiration.
in 2 yr
Patent 9616059 expires
Listed method-of-use patent (U-2618) expiration.
in 2 yr
Exclusivity ends · ODE-448
Orphan-drug exclusivity (7 years)
in 4 yr 4 mo
Patent 8299057 expires
Listed drug substance patent expiration.
in 5 yr 8 mo
Patent 9085565 expires
Listed drug substance patent expiration.
in 6 yr 11 mo
Patent 9649306 expires
Listed method-of-use patent (U-2618) expiration.
in 6 yr 11 mo
Patent 9649306 expires
Listed method-of-use patent (U-2617) expiration.
in 6 yr 11 mo
Patent 10231965 expires
Listed method-of-use patent (U-2618) expiration.
in 8 yr 8 mo
Patent 10231965 expires
Listed method-of-use patent (U-2617) expiration.
in 8 yr 8 mo
Patent 10561651 expires
Listed method-of-use patent (U-2745) expiration.
in 8 yr 8 mo
Patent 10738037 expires
Listed drug substance patent expiration.
in 11 yr
Patent 11091469 expires
Listed method-of-use patent (U-2617) expiration.
in 11 yr
Patent 11091469 expires
Listed method-of-use patent (U-2618) expiration.
in 11 yr
Patent 10398693 expires
Listed drug product patent expiration.
in 12 yr 2 mo
Patent 11253515 expires
Listed drug product patent expiration.
in 12 yr 2 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
ENTRECTINIB
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212725
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Marketing exclusivity
Hatch-Waxman- ODE-265Orphan-drug exclusivity (7 years)
in 20 d
- ODE-313Orphan-drug exclusivity (7 years)
in 20 d
- NPPNew patient population exclusivity (3 years)
in 3 mo
- ODE-448Orphan-drug exclusivity (7 years)
in 4 yr 4 mo
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 8673893 | in 2 yr | U-2618 | |
| 8673893 | in 2 yr | U-2617 | |
| 9029356 | in 2 yr | SubstanceProduct | |
| 9085558 | in 2 yr | Product | |
| 9255087 | in 2 yr | U-2618 | |
| 9255087 | in 2 yr | U-2617 | |
| 9616059 | in 2 yr | U-2618 | |
| 8299057 | in 5 yr 8 mo | SubstanceProduct | |
| 9085565 | in 6 yr 11 mo | SubstanceProduct | |
| 9649306 | in 6 yr 11 mo | U-2618 | |
| 9649306 | in 6 yr 11 mo | U-2617 | |
| 10231965 | in 8 yr 8 mo | U-2618 | |
| 10231965 | in 8 yr 8 mo | U-2617 | |
| 10561651 | in 8 yr 8 mo | U-2745 | |
| 10738037 | in 11 yr | SubstanceProductU-2946 | |
| 11091469 | in 11 yr | U-2617 | |
| 11091469 | in 11 yr | U-2618 | |
| 10398693 | in 12 yr 2 mo | Product | |
| 11253515 | in 12 yr 2 mo | Product |
RLDRS
- Strength
- 200MG
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
7 yr 1 mo ago
Today
Exclusivity ends · ODE-265
Orphan-drug exclusivity (7 years)
in 20 d
Exclusivity ends · ODE-313
Orphan-drug exclusivity (7 years)
in 20 d
Exclusivity ends · NPP
New patient population exclusivity (3 years)
in 3 mo
Patent 8673893 expires
Listed method-of-use patent (U-2618) expiration.
in 2 yr
Patent 8673893 expires
Listed method-of-use patent (U-2617) expiration.
in 2 yr
Patent 9029356 expires
Listed drug substance patent expiration.
in 2 yr
Patent 9085558 expires
Listed drug product patent expiration.
in 2 yr
Patent 9255087 expires
Listed method-of-use patent (U-2618) expiration.
in 2 yr
Patent 9255087 expires
Listed method-of-use patent (U-2617) expiration.
in 2 yr
Patent 9616059 expires
Listed method-of-use patent (U-2618) expiration.
in 2 yr
Exclusivity ends · ODE-448
Orphan-drug exclusivity (7 years)
in 4 yr 4 mo
Patent 8299057 expires
Listed drug substance patent expiration.
in 5 yr 8 mo
Patent 9085565 expires
Listed drug substance patent expiration.
in 6 yr 11 mo
Patent 9649306 expires
Listed method-of-use patent (U-2618) expiration.
in 6 yr 11 mo
Patent 9649306 expires
Listed method-of-use patent (U-2617) expiration.
in 6 yr 11 mo
Patent 10231965 expires
Listed method-of-use patent (U-2618) expiration.
in 8 yr 8 mo
Patent 10231965 expires
Listed method-of-use patent (U-2617) expiration.
in 8 yr 8 mo
Patent 10561651 expires
Listed method-of-use patent (U-2745) expiration.
in 8 yr 8 mo
Patent 10738037 expires
Listed drug substance patent expiration.
in 11 yr
Patent 11091469 expires
Listed method-of-use patent (U-2617) expiration.
in 11 yr
Patent 11091469 expires
Listed method-of-use patent (U-2618) expiration.
in 11 yr
Patent 10398693 expires
Listed drug product patent expiration.
in 12 yr 2 mo
Patent 11253515 expires
Listed drug product patent expiration.
in 12 yr 2 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
ENTRECTINIB
Strength
200MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212725
Product number
002
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Marketing exclusivity
Hatch-Waxman- ODE-265Orphan-drug exclusivity (7 years)
in 20 d
- ODE-313Orphan-drug exclusivity (7 years)
in 20 d
- NPPNew patient population exclusivity (3 years)
in 3 mo
- ODE-448Orphan-drug exclusivity (7 years)
in 4 yr 4 mo
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 8673893 | in 2 yr | U-2618 | |
| 8673893 | in 2 yr | U-2617 | |
| 9029356 | in 2 yr | SubstanceProduct | |
| 9085558 | in 2 yr | Product | |
| 9255087 | in 2 yr | U-2618 | |
| 9255087 | in 2 yr | U-2617 | |
| 9616059 | in 2 yr | U-2618 | |
| 8299057 | in 5 yr 8 mo | SubstanceProduct | |
| 9085565 | in 6 yr 11 mo | SubstanceProduct | |
| 9649306 | in 6 yr 11 mo | U-2618 | |
| 9649306 | in 6 yr 11 mo | U-2617 | |
| 10231965 | in 8 yr 8 mo | U-2618 | |
| 10231965 | in 8 yr 8 mo | U-2617 | |
| 10561651 | in 8 yr 8 mo | U-2745 | |
| 10738037 | in 11 yr | SubstanceProductU-2946 | |
| 11091469 | in 11 yr | U-2617 | |
| 11091469 | in 11 yr | U-2618 | |
| 10398693 | in 12 yr 2 mo | Product | |
| 11253515 | in 12 yr 2 mo | Product |
Other FDA applications for Rozlytrek
1 additional filing
The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.
| Application | Applicant | Approved | Strengths | TE code | Status |
|---|---|---|---|---|---|
| NDA 218550 | Genentech Inc | Oct 20, 2023 | 1 | — | Prescription |
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.
No other applications share this active ingredient.
View full Entrectinib familyHow 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.
Rozlytrek: 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 212725 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.
