FDA application holder
Global Blood Therapeutics Inc
The Orange Book identifies this organization as the applicant responsible for NDA 213137.
Orange Book drug · Brand (NDA)
Oxbryta
Voxelotor
DiscontinuedRLDNDA 213137 2 strengths Global Blood Theraps
Approved
Nov 25, 2019
Strengths
2
Listed patents
11
Applications
2
What does the FDA Orange Book show for Oxbryta?
Oxbryta contains Voxelotor and appears in 2 FDA Orange Book applications. NDA 213137 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 213137
- Lead application holder
- Global Blood Therapeutics Inc
- Product presentations
- 2
- Marketing categories
- Discontinued
- Reference roles
- RLD
- TE codes
- None posted
- Listed patents
- 11
- Exclusivity records
- 2
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 | 500MG | TABLETORAL | Discontinued | None posted | RLD |
| 002 | 300MG | TABLETORAL | 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
2 presentations 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
11 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026
The latest future date recorded across those files is Oct 12, 2037. 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 213137 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
Voxelotor
- Product rows
- 2
- Active applications
- 0
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-213137
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 213137
RLDDiscontinued
- Strength
- 500MG
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
6 yr 9 mo ago
Today
Exclusivity ends · ODE-281
Orphan-drug exclusivity (7 years)
in 4 mo
Exclusivity ends · ODE-394
Orphan-drug exclusivity (7 years)
in 2 yr 5 mo
Patent 10017491 expires
Listed drug product patent expiration.
in 6 yr 6 mo
Patent 10034879 expires
Listed drug substance patent expiration.
in 6 yr 6 mo
Patent 10806733 expires
Listed drug substance patent expiration.
in 6 yr 6 mo
Patent 9018210 expires
Listed drug substance patent expiration.
in 7 yr 5 mo
Patent 9248199 expires
Listed method-of-use patent (U-2676) expiration.
in 7 yr 7 mo
Patent 9248199 expires
Listed method-of-use patent (U-2715) expiration.
in 7 yr 7 mo
Patent 10722502 expires
Listed drug product patent expiration.
in 8 yr 8 mo
Patent 11452720 expires
Listed method-of-use patent (U-3459) expiration.
in 8 yr 8 mo
Patent 9447071 expires
Listed drug substance patent expiration.
in 8 yr 8 mo
Patent 11020382 expires
Listed method-of-use patent (U-3133) expiration.
in 10 yr 6 mo
Patent 11020382 expires
Listed method-of-use patent (U-3134) expiration.
in 10 yr 6 mo
Patent 11944612 expires
Listed method-of-use patent (U-3893) expiration.
in 10 yr 6 mo
Patent 10493035 expires
Listed drug product patent expiration.
in 11 yr 5 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
VOXELOTOR
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213137
Product number
001
Marketing status
Discontinued
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Marketing exclusivity
Hatch-Waxman- ODE-281Orphan-drug exclusivity (7 years)
in 4 mo
- ODE-394Orphan-drug exclusivity (7 years)
in 2 yr 5 mo
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 10017491 | in 6 yr 6 mo | Product | |
| 10034879 | in 6 yr 6 mo | SubstanceProduct | |
| 10806733 | in 6 yr 6 mo | Substance | |
| 9018210 | in 7 yr 5 mo | SubstanceProduct | |
| 9248199 | in 7 yr 7 mo | U-2676 | |
| 9248199 | in 7 yr 7 mo | U-2715 | |
| 10722502 | in 8 yr 8 mo | Product | |
| 11452720 | in 8 yr 8 mo | U-3459 | |
| 9447071 | in 8 yr 8 mo | SubstanceProduct | |
| 11020382 | in 10 yr 6 mo | U-3133 | |
| 11020382 | in 10 yr 6 mo | U-3134 | |
| 11944612 | in 10 yr 6 mo | U-3893 | |
| 10493035 | in 11 yr 5 mo | Product |
RLDDiscontinued
- Strength
- 300MG
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
3 yr 10 mo ago
Today
Exclusivity ends · ODE-394
Orphan-drug exclusivity (7 years)
in 2 yr 5 mo
Patent 10017491 expires
Listed drug product patent expiration.
in 6 yr 6 mo
Patent 10034879 expires
Listed drug substance patent expiration.
in 6 yr 6 mo
Patent 10806733 expires
Listed drug substance patent expiration.
in 6 yr 6 mo
Patent 9018210 expires
Listed drug substance patent expiration.
in 7 yr 5 mo
Patent 9248199 expires
Listed method-of-use patent (U-2676) expiration.
in 7 yr 7 mo
Patent 9248199 expires
Listed method-of-use patent (U-2715) expiration.
in 7 yr 7 mo
Patent 10722502 expires
Listed drug product patent expiration.
in 8 yr 8 mo
Patent 11452720 expires
Listed method-of-use patent (U-3459) expiration.
in 8 yr 8 mo
Patent 9447071 expires
Listed drug substance patent expiration.
in 8 yr 8 mo
Patent 11020382 expires
Listed method-of-use patent (U-3133) expiration.
in 10 yr 6 mo
Patent 11020382 expires
Listed method-of-use patent (U-3134) expiration.
in 10 yr 6 mo
Patent 11944612 expires
Listed method-of-use patent (U-3893) expiration.
in 10 yr 6 mo
Patent 10493035 expires
Listed drug product patent expiration.
in 11 yr 5 mo
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
VOXELOTOR
Strength
300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213137
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Marketing exclusivity
Hatch-Waxman- ODE-394Orphan-drug exclusivity (7 years)
in 2 yr 5 mo
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 10017491 | in 6 yr 6 mo | Product | |
| 10034879 | in 6 yr 6 mo | SubstanceProduct | |
| 10806733 | in 6 yr 6 mo | Substance | |
| 9018210 | in 7 yr 5 mo | SubstanceProduct | |
| 9248199 | in 7 yr 7 mo | U-2676 | |
| 9248199 | in 7 yr 7 mo | U-2715 | |
| 10722502 | in 8 yr 8 mo | Product | |
| 11452720 | in 8 yr 8 mo | U-3459 | |
| 9447071 | in 8 yr 8 mo | SubstanceProduct | |
| 11020382 | in 10 yr 6 mo | U-3133 | |
| 11020382 | in 10 yr 6 mo | U-3134 | |
| 11944612 | in 10 yr 6 mo | U-3893 | |
| 10493035 | in 11 yr 5 mo | Product |
Other FDA applications for Oxbryta
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 216157 | Global Blood Theraps | Dec 17, 2021 | 1 | — | Discontinued |
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 Voxelotor 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.
Oxbryta: 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 213137 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.
