AUGTYRO Drug Patent Profile

Which patents cover Augtyro, and what generic alternatives are available?

Augtyro is a drug marketed by Bristol and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and fifty-four patent family members in thirty-eight countries.

The generic ingredient in AUGTYRO is repotrectinib. One supplier is listed for this compound. Additional details are available on the repotrectinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Augtyro

Augtyro will be eligible for patent challenges on November 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 5, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AUGTYRO

International Patents:	154
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	435
Drug Prices:	Drug price information for AUGTYRO
What excipients (inactive ingredients) are in AUGTYRO?	AUGTYRO excipients list
DailyMed Link:	AUGTYRO at DailyMed

See drug prices for AUGTYRO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AUGTYRO

NDA:

218213

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AUGTYRO

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors Tropomyosin Receptor Tyrosine Kinase A Inhibitors Tropomyosin Receptor Tyrosine Kinase B Inhibitors Tropomyosin Receptor Tyrosine Kinase C Inhibitors

US Patents and Regulatory Information for AUGTYRO

AUGTYRO is protected by six US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes			Y	Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	Yes			Y	Y

International Patents for AUGTYRO

When does loss-of-exclusivity occur for AUGTYRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AUGTYRO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016289454
Brazil	112018000297
Canada	2990020
China	108026108
China	113354653
Denmark	3319969
European Patent Office	3319969

Supplementary Protection Certificates for AUGTYRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3572416	C20250015	Finland		PRODUCT NAME: IMETELSTAAT;REG NO/DATE: EU/1/24/1894 11.03.2025
3572416	301322	Netherlands		PRODUCT NAME: REPOTRECTINIB EN/OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/24/1883 20250114
3572416	CA 2025 00011	Denmark		PRODUCT NAME: REPOTRECTINIB OG/ELLER FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF; REG. NO/DATE: EU/1/24/1883 20250114
3572416	LUC00383	Luxembourg		PRODUCT NAME: REPOTRECTINIB ET/OU SES SELS ET ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE:
3572416	PA2025513	Lithuania		PRODUCT NAME: REPOTREKTINIBAS IR (ARBA) JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IRESTERIAI; REGISTRATION NO/DATE: EU/1/24/1883/001-004 20250113
3572416	2590010-1	Sweden		PRODUCT NAME: REPOTRECTINIB OCH/ELLER FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/24/1883 20250114
3572416	122025000017	Germany		PRODUCT NAME: REPOTRECTINIB UND/ODER PHARMAZEUTISCH ANNEHMBARE SALZE UND ESTER DAVON; REGISTRATION NO/DATE: EU/1/24/1883 20250113

AUGTYRO Market Dynamics, Revenue Trajectory, Patent Exclusivity, and Generic Risk

Last updated: August 3, 2026

AUGTYRO, or repotrectinib, is Bristol Myers Squibb's targeted therapy for ROS1-positive non-small cell lung cancer and NTRK gene fusion-positive solid tumors. Its commercial opportunity is driven by strong central nervous system activity, activity against resistance mutations, and a once-daily oral regimen. Its principal limitation is the small biomarker-defined patient population.

Bristol Myers Squibb reported approximately $139 million in AUGTYRO sales for 2024, compared with approximately $6 million in 2023 after the drug's November 2023 U.S. launch. The product remains in an early launch phase, with revenue dependent on molecular testing, treatment-line adoption, reimbursement, and expansion outside the United States. [1]

What is AUGTYRO approved to treat?

AUGTYRO is an oral tyrosine kinase inhibitor targeting ROS1 and TRK proteins encoded by the NTRK1, NTRK2, and NTRK3 genes.

Regulatory milestone	Date	Commercial significance
FDA approval for ROS1-positive locally advanced or metastatic NSCLC	November 15, 2023	Initial U.S. launch indication
FDA approval for adult and pediatric patients age 12 and older with NTRK gene fusion-positive solid tumors	June 13, 2024	Expanded population and tumor-agnostic use
Approved dosage	160 mg once daily for 14 days, then 160 mg twice daily	Continuous oral treatment
Primary development study	TRIDENT-1	Supported ROS1 and NTRK approvals
FDA pathway	New drug application and supplemental new drug application	Small-molecule regulatory pathway

The ROS1 approval covers patients with locally advanced or metastatic disease. The NTRK indication is tumor agnostic, meaning eligibility depends on the presence of an NTRK gene fusion rather than the anatomical origin of the tumor. [2,3]

How does AUGTYRO work against ROS1 and NTRK cancers?

AUGTYRO inhibits ROS1 and TRKA, TRKB, and TRKC signaling. The drug was designed to retain activity against several kinase-domain resistance mutations that can emerge after treatment with earlier ROS1 inhibitors.

The main technical differentiators are:

• Intracranial activity in patients with brain metastases.
• Activity against ROS1 solvent-front mutations, including G2032R.
• Activity against certain acquired resistance mutations.
• Once-daily dosing during the initial 14-day period, followed by twice-daily dosing.
• Use in both adult and adolescent patients for approved indications.

The competitive value of these attributes depends on clinical sequencing. A patient who develops a resistance mutation after crizotinib or entrectinib may have fewer effective options, making repotrectinib more valuable in later-line treatment. The commercial challenge is that many patients receive an earlier-generation ROS1 inhibitor and remain on treatment for extended periods.

How large is the AUGTYRO market opportunity?

AUGTYRO addresses two rare molecular populations rather than the entire lung cancer market.

ROS1-positive NSCLC

ROS1 rearrangements occur in approximately 1% to 2% of NSCLC cases. The population is enriched for younger patients, never-smokers, and patients with metastatic disease. The U.S. opportunity is limited by:

• Low biomarker prevalence.
• Improving survival with sequential targeted therapy.
• Competition from XALKORI, ROZLYTREK, and off-label or investigational kinase inhibitors.
• Need for broad next-generation sequencing.
• Potential use of AUGTYRO later in the treatment sequence.

ROS1-positive NSCLC is the main commercial indication because it has a larger diagnosed population and more established testing pathways than NTRK fusion-positive disease.

NTRK fusion-positive solid tumors

NTRK fusions are rare, generally occurring in less than 1% of unselected solid tumors. They can appear across multiple tumor types, including lung, thyroid, sarcoma, colorectal, and salivary gland cancers.

The NTRK market has a higher per-patient value but a smaller volume. AUGTYRO competes with larotrectinib, marketed as VITRAKVI, and entrectinib, marketed as ROZLYTREK. Durable responses and tissue-agnostic labeling support premium pricing, but diagnostic identification remains the main constraint.

Commercial addressability

Market driver	Effect on AUGTYRO
ROS1 testing	Expands the initial eligible population
NTRK testing	Creates access to tumor-agnostic treatment
Brain metastases	Supports use where CNS penetration is important
Resistance mutations	Supports sequencing after earlier TKIs
Long treatment duration	Increases revenue per treated patient
Rare biomarker prevalence	Limits total patient volume
Competing targeted drugs	Constrains pricing and treatment share

What were AUGTYRO sales and what is the financial trajectory?

Bristol Myers Squibb acquired Turning Point Therapeutics in 2022 for approximately $4.1 billion in cash. The acquisition gave BMS control of repotrectinib before U.S. approval. [4]

BMS reported the following approximate AUGTYRO net sales:

Fiscal year	Net sales	Commercial stage
2023	$6 million	U.S. launch late in the year
2024	$139 million	First full launch year and NTRK expansion

The 2024 result indicates rapid uptake from a low base, but it does not yet establish blockbuster economics. A potential revenue path depends on four variables:

1. ROS1 market share against crizotinib, entrectinib, and future entrants.
2. Use after progression on first-line ROS1 therapy.
3. NTRK testing and adoption in community oncology.
4. International reimbursement and regulatory expansion.

AUGTYRO is more likely to become a meaningful specialty oncology product than a mass-market asset. Revenue could increase materially if physicians use it broadly in first-line ROS1 disease and if resistance mutation testing drives later-line prescribing. The revenue ceiling is constrained by the size of the biomarker populations.

BMS's acquisition economics also matter. The $4.1 billion transaction was based on the value of repotrectinib's development and commercial potential, not on current sales. At approximately $139 million in 2024 sales, reported revenue remained substantially below the acquisition consideration. The investment thesis therefore depends on several years of growth, label expansion, geographic commercialization, and durable pricing.

What patents protect AUGTYRO?

AUGTYRO is protected by a combination of composition-of-matter, pharmaceutical composition, therapeutic-use, and regulatory exclusivity rights.

The core patent position originated with Turning Point Therapeutics and related research entities. The relevant protection categories include:

Protection category	Scope
Composition of matter	Repotrectinib molecule and related chemical structures
Pharmaceutical composition	Drug compositions containing repotrectinib
Treatment methods	Use in ROS1- or NTRK-driven cancers
Solid forms and formulations	Potential protection for crystalline forms, salts, or dosage compositions
Regulatory exclusivity	FDA new chemical entity exclusivity and indication-specific protections

The core patent family was filed years before approval, so the effective patent term is shorter than a full 20 years after launch. Patent term adjustment, patent-term extension, continuation patents, and Orange Book listing practice will determine the practical end of U.S. generic litigation protection.

The FDA Orange Book is the controlling public source for listed patents and expiration dates. The patent estate should be reviewed separately from FDA regulatory exclusivity because a patent expiry date and a market-entry date are not always identical. [5]

When does AUGTYRO lose U.S. exclusivity?

AUGTYRO received five years of new chemical entity exclusivity from its first FDA approval in November 2023. That period generally runs through November 2028, subject to the statutory framework governing NCE exclusivity and any applicable regulatory protections. [2]

The commercial exclusivity timeline is:

Protection	Expected timing	Effect
Five-year NCE exclusivity	Through approximately November 2028	Blocks submission of an ANDA containing a Paragraph IV certification during the initial period, subject to statutory exceptions
Patent protection	Potentially beyond 2028	Depends on Orange Book-listed patents, term adjustment, and litigation
NTRK indication exclusivity	Depends on applicable FDA designation and listing	May protect the indication without blocking all generic entry
Generic approval	Potentially after NCE and patent barriers	Requires successful ANDA review and resolution of litigation

A generic applicant may file a Paragraph IV certification against listed patents before patent expiry. Filing can trigger patent litigation and a potential 30-month stay of FDA approval under the Hatch-Waxman framework. The relevant date for commercial entry is therefore determined by the earliest surviving combination of regulatory approval, patent resolution, settlement terms, and court outcome.

Are there AUGTYRO Paragraph IV challenges or generic lawsuits?

No major public Paragraph IV litigation or generic launch settlement had been publicly established through the early commercial period covered by the available reporting. The five-year NCE period also delays ordinary ANDA filing, although statutory exceptions can permit earlier patent challenges.

The principal litigation risk is likely to arise later from:

• Challenges to composition-of-matter patents.
• Challenges to formulation or solid-form patents.
• Method-of-use certifications directed to ROS1 or NTRK treatment.
• Skinny-label strategies that omit patented indications.
• Patent settlements allowing a defined launch date before all listed patents expire.

Because AUGTYRO treats a narrow molecular population, a generic company may have less incentive to litigate early than it would for a high-volume primary-care drug. That incentive can change if the drug develops a durable specialty-oncology revenue base.

What is the Orange Book status of AUGTYRO?

AUGTYRO is an FDA-approved small-molecule prescription drug and is subject to the Hatch-Waxman framework. It is not a biologic and does not use the Purple Book biosimilar pathway.

Orange Book issues relevant to AUGTYRO include:

• Listed patents for the approved product.
• Patent expiration and any patent-term adjustment.
• Whether later formulation patents are listed.
• Whether method-of-use patents cover all commercial indications or only selected uses.
• Whether a generic could design around formulation or dosing claims.
• Whether a Paragraph IV filing would trigger a 30-month stay.

AUGTYRO has no biosimilar risk because biosimilars apply to biological products. Its competitive erosion risk comes from ANDA-approved generics, competing targeted therapies, and next-generation kinase inhibitors.

How strong is the AUGTYRO patent estate?

The estate is commercially meaningful but must be assessed by claim type.

Strongest protection

Composition-of-matter claims generally provide the strongest barrier because a generic containing the same active ingredient may directly infringe if the claims remain valid and enforceable. These claims can support broad protection across indications and dosage forms.

More vulnerable protection

Method-of-use claims can be narrower and may be challenged through:

• Non-infringement arguments.
• Invalidity arguments based on prior art.
• Skinny-label product labeling.
• Assertions that the indication is not actively induced by the generic manufacturer.

Formulation and solid-form claims can protect specific products but may be designed around through alternative excipients, polymorphs, particle sizes, or manufacturing processes. Their value depends on whether the commercial product requires the claimed form and whether the generic can use an alternative form.

The most important variables are claim breadth, priority dates, continuation prosecution, patent-term adjustment, written-description support, and the strength of clinical evidence underlying method-of-use claims.

Which companies compete with AUGTYRO?

Company	Product	Target or market position
Pfizer	XALKORI, crizotinib	Established ROS1 therapy; earlier-generation profile
Roche	ROZLYTREK, entrectinib	ROS1 and NTRK competition with CNS activity
Bayer	VITRAKVI, larotrectinib	Direct NTRK tumor-agnostic competitor
Bristol Myers Squibb	AUGTYRO, repotrectinib	ROS1 and NTRK; resistance mutation and CNS positioning
Future developers	Next-generation ROS1 inhibitors	Potential pressure on sequencing and first-line share

AUGTYRO's closest direct commercial comparisons are ROZLYTREK in ROS1-positive NSCLC and VITRAKVI in NTRK fusion-positive tumors. AUGTYRO's differentiation depends less on broad market access and more on mutation coverage, intracranial efficacy, treatment sequencing, and physician confidence.

What generic entry risks exist for AUGTYRO?

The most likely generic entry scenarios are:

1. Delayed entry after NCE exclusivity and patent expiry.
2. A Paragraph IV challenge followed by settlement.
3. A skinny-label generic targeting non-patented uses.
4. A generic launch after invalidation or non-infringement of key patents.
5. Limited early generic competition because of the small market.

Erosion could be slower than for a high-volume drug because the eligible population is small and treatment is prescribed by oncology specialists. It could also be faster if several generic companies enter simultaneously after the core patent barrier falls.

The larger near-term risk is competitive substitution rather than generic substitution. Physicians may choose another ROS1 or NTRK inhibitor based on line of therapy, CNS disease, adverse-event profile, payer policy, or local testing practices.

What regulatory and manufacturing barriers affect AUGTYRO?

AUGTYRO requires specialized oncology commercialization rather than large primary-care distribution. Important operating barriers include:

• Reliable production of the active pharmaceutical ingredient.
• Control of solid form and impurity profile.
• Validation of oral capsule manufacturing.
• Global regulatory filings.
• Companion or broad molecular diagnostic access.
• Specialty pharmacy and oncology distribution.
• Pharmacovigilance for neurologic, pulmonary, hepatic, and metabolic adverse events.

Manufacturing patents can complicate generic development if they cover a necessary synthetic route or commercially preferred solid form. They rarely create an absolute barrier if an alternative process is available, but process changes require development, validation, and regulatory support.

What licensing deals affect AUGTYRO?

The central transaction was Bristol Myers Squibb's acquisition of Turning Point Therapeutics in 2022. BMS paid approximately $76 per share in cash, representing an aggregate equity value of about $4.1 billion. [4]

The transaction transferred the repotrectinib program, associated development rights, and the originating company's oncology pipeline to BMS. It was an acquisition rather than a conventional post-approval licensing agreement.

The deal provides BMS with global commercialization control and allows the company to use its existing oncology infrastructure. The main financial question is whether AUGTYRO can generate sufficient cumulative sales before patent-protected exclusivity declines.

Key Takeaways

• AUGTYRO is a targeted ROS1 and NTRK inhibitor marketed by Bristol Myers Squibb.
• FDA approval began with ROS1-positive metastatic NSCLC in November 2023 and expanded to NTRK fusion-positive solid tumors in June 2024.
• BMS reported approximately $139 million in 2024 AUGTYRO sales.
• The drug's principal advantages are CNS activity and activity against selected resistance mutations.
• The addressable market is limited by the rarity of ROS1 and NTRK alterations.
• Five-year NCE exclusivity is expected to run approximately through November 2028.
• Patent-based protection may extend beyond the NCE period, subject to Orange Book listings, patent-term adjustment, and litigation.
• AUGTYRO has generic risk, not biosimilar risk.
• The $4.1 billion Turning Point acquisition requires sustained growth, international expansion, and strong treatment-sequencing adoption to support the purchase economics.
• Competitive substitution from XALKORI, ROZLYTREK, VITRAKVI, and future ROS1 inhibitors may precede material generic erosion.

FAQs About AUGTYRO Market and Patent Risk

Is AUGTYRO a blockbuster drug?

AUGTYRO had not reached blockbuster sales based on reported 2024 revenue of approximately $139 million. It could become a larger specialty-oncology product if ROS1 first-line adoption, later-line use, NTRK testing, and international reimbursement expand.

Is AUGTYRO better than XALKORI?

AUGTYRO has a more modern clinical profile in areas such as CNS activity and resistance mutation coverage. The appropriate choice depends on treatment line, mutation status, brain metastases, tolerability, clinical guidelines, and payer access.

Does AUGTYRO have orphan-drug exclusivity?

The commercial protection analysis should distinguish orphan-drug exclusivity from NCE exclusivity and patent rights. FDA regulatory exclusivity depends on the specific designation, indication, and agency records associated with each approval.

Can a generic company make repotrectinib before 2028?

The five-year NCE period generally restricts ordinary ANDA approval before November 2028. A generic applicant may pursue statutory patent-certification strategies earlier, but commercial launch would depend on FDA approval, patent litigation, and any settlement.

What is the biggest commercial risk for AUGTYRO?

The largest risk is limited patient volume combined with intense targeted-therapy competition. Molecular testing and treatment sequencing will determine whether AUGTYRO captures enough ROS1 and NTRK patients to support the acquisition valuation.

References

1. Bristol Myers Squibb. (2025). 2024 annual report. Bristol Myers Squibb Company.

2. U.S. Food and Drug Administration. (2023, November 15). FDA approves repotrectinib for ROS1-positive metastatic non-small cell lung cancer. U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (2024, June 13). FDA approves repotrectinib for NTRK gene fusion-positive solid tumors. U.S. Department of Health and Human Services.

4. Bristol Myers Squibb. (2022, August 17). Bristol Myers Squibb completes acquisition of Turning Point Therapeutics. Bristol Myers Squibb Company.

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

DrugChatter Q&A for AUGTYRO

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