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Orange Book drug · Brand (NDA)

Kisqali Femara Co-pack (copackaged)

Letrozole; Ribociclib Succinate

RLDNDA 209935 Novartis
Approved
May 04, 2017
Strengths
1
Listed patents
22

What does the FDA Orange Book show for Kisqali Femara Co-pack (copackaged)?

Kisqali Femara Co-pack (copackaged) contains Letrozole; Ribociclib Succinate and is the new drug FDA Orange Book record for NDA 209935. 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 209935

New drug application identity from the Orange Book snapshot.

Application holder
Novartis Pharmaceuticals Corp

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
22

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
2

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
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0012.5MG;EQ 200MG BASETABLETORALPrescriptionNone 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

FDA application holder

Novartis Pharmaceuticals Corp

The Orange Book identifies this organization as the applicant responsible for NDA 209935.

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

22 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Oct 14, 2036. 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 209935 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

Letrozole; Ribociclib Succinate

1 application
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-209935

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 209935
RLDRS
Strength
2.5MG;EQ 200MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    9 yr 4 mo ago

  2. Today

  3. Exclusivity ends · I-951

    New indication exclusivity (3 years)

    in 1 yr 2 mo

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 8 mo

  5. Patent 8324225 expires

    Listed drug substance patent expiration.

    in 1 yr 11 mo

  6. Patent 8324225*PED expires

    Listed listed patent expiration.

    in 2 yr 5 mo

  7. Patent 9416136 expires

    Listed method-of-use patent (U-2505) expiration.

    in 3 yr 1 mo

  8. Patent 9416136 expires

    Listed method-of-use patent (U-3998) expiration.

    in 3 yr 1 mo

  9. Patent 9416136 expires

    Listed method-of-use patent (U-3264) expiration.

    in 3 yr 1 mo

  10. Patent 8962630 expires

    Listed method-of-use patent (U-2505) expiration.

    in 3 yr 5 mo

  11. Patent 8962630 expires

    Listed method-of-use patent (U-3998) expiration.

    in 3 yr 5 mo

  12. Patent 8962630 expires

    Listed method-of-use patent (U-3264) expiration.

    in 3 yr 5 mo

  13. Patent 9416136*PED expires

    Listed listed patent expiration.

    in 3 yr 8 mo

  14. Patent 8685980 expires

    Listed drug substance patent expiration.

    in 3 yr 11 mo

  15. Patent 8962630*PED expires

    Listed listed patent expiration.

    in 3 yr 11 mo

  16. Patent 8685980*PED expires

    Listed listed patent expiration.

    in 4 yr 5 mo

  17. Patent 8415355 expires

    Listed drug substance patent expiration.

    in 4 yr 8 mo

  18. Patent 8415355*PED expires

    Listed listed patent expiration.

    in 5 yr 3 mo

  19. Patent 9193732 expires

    Listed drug substance patent expiration.

    in 5 yr 4 mo

  20. Patent 9868739 expires

    Listed method-of-use patent (U-3998) expiration.

    in 5 yr 4 mo

  21. Patent 9868739 expires

    Listed method-of-use patent (U-2505) expiration.

    in 5 yr 4 mo

  22. Patent 9868739 expires

    Listed method-of-use patent (U-3264) expiration.

    in 5 yr 4 mo

  23. Patent 9193732*PED expires

    Listed listed patent expiration.

    in 5 yr 10 mo

  24. Patent 9868739*PED expires

    Listed listed patent expiration.

    in 5 yr 10 mo

  25. Patent 12544380 expires

    Listed method-of-use patent (U-3264) expiration.

    in 8 yr 2 mo

  26. Patent 12544380 expires

    Listed method-of-use patent (U-3998) expiration.

    in 8 yr 2 mo

  27. Patent 12544380*PED expires

    Listed listed patent expiration.

    in 8 yr 8 mo

  28. Patent 10799506 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  29. Patent 12064434 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  30. Patent 12419894 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  31. Patent 10799506*PED expires

    Listed listed patent expiration.

    in 10 yr 4 mo

  32. Patent 12064434*PED expires

    Listed listed patent expiration.

    in 10 yr 4 mo

  33. Patent 12419894*PED expires

    Listed listed patent expiration.

    in 10 yr 4 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayExclusivity I-951: 2027-09-17Exclusivity I-951Exclusivity PED: 2028-03-17Exclusivity PEDPatent 8324225: 2028-06-17Patent 8324225Patent 8324225*PED: 2028-12-17Patent 8324225*PEDPatent 9416136: 2029-08-20Patent 9416136Patent 9416136: 2029-08-20Patent 9416136Patent 9416136: 2029-08-20Patent 9416136Patent 8962630: 2029-12-09Patent 8962630Patent 8962630: 2029-12-09Patent 8962630Patent 8962630: 2029-12-09Patent 8962630Patent 9416136*PED: 2030-02-20Patent 9416136*PEDPatent 8685980: 2030-05-25Patent 8685980Patent 8962630*PED: 2030-06-09Patent 8962630*PEDPatent 8685980*PED: 2030-11-25Patent 8685980*PEDPatent 8415355: 2031-03-13Patent 8415355Patent 8415355*PED: 2031-09-13Patent 8415355*PEDPatent 9193732: 2031-11-09Patent 9193732Patent 9868739: 2031-11-09Patent 9868739Patent 9868739: 2031-11-09Patent 9868739Patent 9868739: 2031-11-09Patent 9868739Patent 9193732*PED: 2032-05-09Patent 9193732*PEDPatent 9868739*PED: 2032-05-09Patent 9868739*PEDPatent 12544380: 2034-08-07Patent 12544380Patent 12544380: 2034-08-07Patent 12544380Patent 12544380*PED: 2035-02-07Patent 12544380*PEDPatent 10799506: 2036-04-14Patent 10799506Patent 12064434: 2036-04-14Patent 12064434Patent 12419894: 2036-04-14Patent 12419894Patent 10799506*PED: 2036-10-14Patent 10799506*PEDPatent 12064434*PED: 2036-10-14Patent 12064434*PEDPatent 12419894*PED: 2036-10-14Patent 12419894*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

LETROZOLE; RIBOCICLIB SUCCINATE

Strength

2.5MG;EQ 200MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209935

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • I-951New indication exclusivity (3 years)

    in 1 yr 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 8 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8324225in 1 yr 11 mo
SubstanceProduct
8324225*PEDin 2 yr 5 mo
9416136in 3 yr 1 mo
U-2505
9416136in 3 yr 1 mo
U-3998
9416136in 3 yr 1 mo
U-3264
8962630in 3 yr 5 mo
U-2505
8962630in 3 yr 5 mo
U-3998
8962630in 3 yr 5 mo
U-3264
9416136*PEDin 3 yr 8 mo
8685980in 3 yr 11 mo
SubstanceProduct
8962630*PEDin 3 yr 11 mo
8685980*PEDin 4 yr 5 mo
8415355in 4 yr 8 mo
SubstanceProduct
8415355*PEDin 5 yr 3 mo
9193732in 5 yr 4 mo
SubstanceProduct
9868739in 5 yr 4 mo
U-3998
9868739in 5 yr 4 mo
U-2505
9868739in 5 yr 4 mo
U-3264
9193732*PEDin 5 yr 10 mo
9868739*PEDin 5 yr 10 mo
12544380in 8 yr 2 mo
U-3264
12544380in 8 yr 2 mo
U-3998
12544380*PEDin 8 yr 8 mo
10799506in 9 yr 10 mo
Product
12064434in 9 yr 10 mo
Product
12419894in 9 yr 10 mo
Product
10799506*PEDin 10 yr 4 mo
12064434*PEDin 10 yr 4 mo
12419894*PEDin 10 yr 4 mo

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 Letrozole; Ribociclib Succinate family

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

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.

Kisqali Femara Co-pack (copackaged): 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 209935 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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