FDA application holder
Bayer Healthcare Pharmaceuticals Inc
The Orange Book identifies this organization as the applicant responsible for NDA 212099.
Orange Book drug · Brand (NDA)
Nubeqa
Darolutamide
RLDNDA 212099 Bayer Healthcare
Approved
Jul 30, 2019
Strengths
1
Listed patents
10
What does the FDA Orange Book show for Nubeqa?
Nubeqa contains Darolutamide and is the new drug FDA Orange Book record for NDA 212099. 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 212099
- Application holder
- Bayer Healthcare Pharmaceuticals Inc
- Product presentations
- 1
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- None posted
- Listed patents
- 10
- 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 | 300MG | TABLETORAL | 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
10 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026
The latest future date recorded across those files is Jun 17, 2042. 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 212099 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Tablet · Oral
Darolutamide
- 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-212099
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 212099
RLDRS
- Strength
- 300MG
- Dosage form
- TABLET
- 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 · I-971
New indication exclusivity (3 years)
in 1 yr 11 mo
Patent 10711013 expires
Listed drug substance patent expiration.
in 4 yr 4 mo
Patent 11046713 expires
Listed drug substance patent expiration.
in 4 yr 4 mo
Patent 9657003 expires
Listed drug substance patent expiration.
in 4 yr 4 mo
Patent 9657003 expires
Listed drug substance patent expiration.
in 4 yr 4 mo
Patent 9657003 expires
Listed drug substance patent expiration.
in 4 yr 4 mo
Patent 8975254 expires
Listed drug substance patent expiration.
in 6 yr 9 mo
Patent 8975254 expires
Listed drug substance patent expiration.
in 6 yr 9 mo
Patent 8975254 expires
Listed drug substance patent expiration.
in 6 yr 9 mo
Patent 10010530 expires
Listed drug substance patent expiration.
in 9 yr 8 mo
Patent 10383853 expires
Listed drug substance patent expiration.
in 9 yr 8 mo
Patent 10835515 expires
Listed drug product patent expiration.
in 9 yr 8 mo
Patent 10835515 expires
Listed drug product patent expiration.
in 9 yr 8 mo
Patent 10835515 expires
Listed drug product patent expiration.
in 9 yr 8 mo
Patent 10835515 expires
Listed drug product patent expiration.
in 9 yr 8 mo
Patent 11168058 expires
Listed drug substance patent expiration.
in 11 yr 9 mo
Patent 12611397 expires
Listed drug product patent expiration.
in 14 yr 2 mo
Patent 12329742 expires
Listed drug product patent expiration.
in 16 yr 2 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
DAROLUTAMIDE
Strength
300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212099
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Marketing exclusivity
Hatch-Waxman- I-971New indication exclusivity (3 years)
in 1 yr 11 mo
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 10711013 | in 4 yr 4 mo | SubstanceProduct | |
| 11046713 | in 4 yr 4 mo | Substance | |
| 9657003 | in 4 yr 4 mo | SubstanceProductU-4209 | |
| 9657003 | in 4 yr 4 mo | SubstanceProductU-4208 | |
| 9657003 | in 4 yr 4 mo | SubstanceProductU-4210 | |
| 8975254 | in 6 yr 9 mo | SubstanceProductU-4208 | |
| 8975254 | in 6 yr 9 mo | SubstanceProductU-4210 | |
| 8975254 | in 6 yr 9 mo | SubstanceProductU-4209 | |
| 10010530 | in 9 yr 8 mo | Substance | |
| 10383853 | in 9 yr 8 mo | Substance | |
| 10835515 | in 9 yr 8 mo | ProductU-4210 | |
| 10835515 | in 9 yr 8 mo | ProductU-4208 | |
| 10835515 | in 9 yr 8 mo | ProductU-4209 | |
| 10835515 | in 9 yr 8 mo | ProductU-2605 | |
| 11168058 | in 11 yr 9 mo | SubstanceProduct | |
| 12611397 | in 14 yr 2 mo | Product | |
| 12329742 | in 16 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.
No other applications share this active ingredient.
View full Darolutamide 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.
Nubeqa: 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 212099 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.
