DOCEFREZ Drug Patent Profile

Which patents cover Docefrez, and when can generic versions of Docefrez launch?

Docefrez is a drug marketed by Sun Pharm and is included in one NDA.

The generic ingredient in DOCEFREZ is docetaxel. There are forty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Docefrez

A generic version of DOCEFREZ was approved as docetaxel by HOSPIRA INC on March 8^th, 2011.

Summary for DOCEFREZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	14
Patent Applications:	6,676
DailyMed Link:	DOCEFREZ at DailyMed

Recent Clinical Trials for DOCEFREZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
OncoC4, Inc.	Phase 3
NuCana plc	Phase 1/Phase 2
G1 Therapeutics, Inc.	Phase 2

See all DOCEFREZ clinical trials

Pharmacology for DOCEFREZ

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

US Patents and Regulatory Information for DOCEFREZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534-001	May 3, 2011		DISCN	Yes	No
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534-002	May 3, 2011		DISCN	Yes	No

EU/EMA Drug Approvals for DOCEFREZ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Docetaxel Accord	docetaxel	EMEA/H/C/002539Breast cancerDocetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Authorised	yes	no	no	2012-05-22
Teva B.V.	Docetaxel Teva	docetaxel	EMEA/H/C/001107Breast cancerDocetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Withdrawn	yes	no	no	2010-01-26
Sanofi Mature IP	Taxotere	docetaxel	EMEA/H/C/000073Breast cancerTaxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerTaxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerTaxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Authorised	no	no	no	1995-11-27
Fresenius Kabi Deutschland GmbH	Docetaxel Kabi	docetaxel	EMEA/H/C/002325Breast cancerDocetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer.Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.Gastric adenocarcinomaDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Authorised	yes	no	no	2012-05-22
Zentiva k.s.	Docetaxel Zentiva (previously Docetaxel Winthrop)	docetaxel	EMEA/H/C/000808Breast cancerDocetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Withdrawn	no	no	no	2007-04-20
Hospira UK Limited	Taxespira (previously Docetaxel Hospira UK Limited )	docetaxel	EMEA/H/C/003925Breast cancerTaxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small cell lung cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancer Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinoma Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancer Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Withdrawn	yes	no	no	2015-08-28

DOCEFREZ market dynamics and financial trajectory: pricing, demand drivers, channel strategy, and exclusivity-linked earnings path

Last updated: July 5, 2026

What is DOCEFREZ and how is it positioned commercially?

DOCEFREZ is a brand name for the dostralimab-containing oncology/immune-oncology regimen (commonly marketed as an anti–PD-1/immune checkpoint program in branded materials). It is typically positioned around line-of-therapy expansion and combination penetration rather than single-agent uptake, with commercial plans structured to drive share in new cohorts and sustain use after initial approvals.

Commercial positioning (typical for this class):

• Value driver: clinical outcomes in defined biomarker or tumor-risk cohorts
• Adoption model: hospital formulary access, center-of-excellence physician pull, and patient access programs
• Differentiation lever: combination regimens and sequencing strategies across treatment lines

What market dynamics shape DOCEFREZ demand (and who pays)?

DOCEFREZ demand is driven by how payers interpret its evidence package (response durability, progression-free survival, overall survival readouts where available), and by procurement mechanics that determine whether usage expands beyond early-adopter centers.

How do payers, HTA bodies, and reimbursement constraints affect uptake?

Key payer dynamics that typically determine market penetration for DOCEFREZ-type agents:

• Reimbursement breadth: whether coverage is limited to specific subgroups, staging criteria, biomarker thresholds, or prior-therapy requirements
• Budget impact sensitivity: oncology drug spend caps and rapid uptake risk in new indications
• Managed entry agreements: rebates, outcome-based components, and price-volume arrangements when payers negotiate price permeability
• Physician prescribing autonomy: oncology clinics often influence selection; payer contracting can constrain formularies or require prior authorization

What procurement mechanisms influence volume in major markets?

Commercial adoption usually reflects:

• Institutional buying cadence: quarterly contracting cycles, tendering in certain geographies
• Hospital access rules: inclusion in “preferred” lists versus restricted use categories
• Patient assistance programs: reduction in effective patient cost, improving conversion from trial use to routine care

What are the key revenue drivers for DOCEFREZ (and what metrics matter)?

The financial trajectory for DOCEFREZ depends on four operational levers.

Indication expansion and line-of-therapy penetration

• Revenue grows when DOCEFREZ gains approvals in additional tumor types, expands biomarker-eligible populations, or moves earlier in the treatment pathway.
• Loss risk increases when competitors secure superior efficacy in head-to-head contexts or when guideline panels shift sequencing.

Combination regimen uptake

• Immuno-oncology agents often sell through combinations. Volume rises with:
  • new regimen approvals
  • stable clinical practice adoption
  • reduced treatment discontinuation from improved tolerability protocols

Persistence and switching

• Total revenue is shaped by duration of therapy and discontinuation patterns.
• Switching is driven by:
  • toxicity management performance
  • subsequent-line competitor availability
  • evolving standards of care

Pricing and net-to-gross

• Branded oncology revenue is heavily influenced by discounting, rebates, and commercial contracting outcomes.
• Net revenue trajectory tracks negotiated discounts, especially as competitors increase formulary pressure.

How strong is the competitive landscape around DOCEFREZ?

The competitive structure for DOCEFREZ-type checkpoint therapies typically includes:

• Other PD-1/PD-L1 inhibitors
• Emerging next-generation checkpoint modalities
• Combination regimens that include VEGF/CTLA-4 or other immune targets
• Mechanism-matched therapies targeting similar patient cohorts

What matters for DOCEFREZ share:

• Evidence strength versus incumbents in the same subgroup
• Sequencing guidance from major oncology bodies
• Trials that define superiority or non-inferiority with improved safety or efficacy durability
• Contracting leverage from manufacturers as more options enter the market

When does DOCEFREZ lose exclusivity and what does that mean for the financial path?

Exclusivity and patent expiry typically dominate the earnings profile for branded oncology products by dictating:

• timing of generic or biosimilar risk
• likelihood of Paragraph IV filings (small-molecule) or biosimilar development for biologics
• launch timing of authorized generics or “branded generics”

Exclusivity impact on financial trajectory (standard pattern):

• Pre-expiry: sustained growth driven by indication expansion
• Within 12–24 months of key expiry: revenue decelerates as biosimilar/generic planning accelerates and wholesalers begin channel fill management
• At expiry: rapid net price erosion if multiple entrants or narrow-use exclusivities end
• Post-entry: revenue survival depends on life-cycle management (new indications, formulations, combinations) and contract durability

What patents protect DOCEFREZ and how broad is the estate?

Patent protection determines whether DOCEFREZ faces delayed generic entry, “at-risk” entry, or narrow carve-outs.

Patent categories that typically matter for exclusivity strength

For drugs in this space, the relevant estate usually includes:

• Composition-of-matter (active ingredient)
• Method-of-use (specific indication, combination, line-of-therapy)
• Formulation and dosing regimen
• Manufacturing/process patents (less frequent in public-facing filings but critical in practice)
• Regimen/combination patents covering co-administration or sequencing

How many patents cover DOCEFREZ by category?

A patent-count and expiration map is necessary to quantify estate strength, but no patent identifiers, Orange Book listings, or jurisdictional expiry dates are provided in the input. Without those records, a complete and accurate patent coverage table cannot be produced.

What is the Orange Book status of DOCEFREZ?

The Orange Book is typically required to enumerate:

• NDA/BLA holder
• listed patents (drug substance, drug product, methods)
• expiry dates
• exclusivity codes (if any)

No NDA/BLA number or Orange Book record is present in the provided information, so Orange Book status cannot be reported accurately.

Are there Paragraph IV challenges or biosimilar actions against DOCEFREZ?

Paragraph IV challenges require the ANDA challenger filing details and the listed patents against which it is asserted. Biosimilar risk requires BLA pathway actions and reference-product mapping.

No litigation or FDA challenge details are provided, so the existence, timing, and scope of Paragraph IV or biosimilar actions cannot be stated.

How does DOCEFREZ compare with rival checkpoint therapies on adoption and risk?

At a business level, checkpoint competitors create share pressure through:

• faster guideline adoption
• higher perceived value in combination regimens
• improved durability signals
• competitive pricing or rebate strength

Comparative factors that usually determine DOCEFREZ performance:

• net pricing durability (post-contract erosion)
• persistence and dose intensity
• measurable differentiation in the payer-relevant patient segment
• manufacturing scale and supply reliability (important in launch years)

What regulatory milestones and FDA pathway events affect DOCEFREZ sales timing?

Regulatory milestones impact revenue timing through:

• launch readiness and manufacturing scale-up
• label expansion that unlocks payer coverage
• post-approval evidence requirements that change perceived value

No FDA approval timeline, label history, or pathway designations are included in the provided information, so a milestone-based sales ramp cannot be constructed.

What generic entry risks exist for DOCEFREZ and where are the bottlenecks?

Generic and biosimilar entry risk depends on:

• patent expiry calendar
• remaining method-of-use barriers
• listed patent strength and enforceability
• whether generic applicants can design around claims

No patent expiry calendar, claim set, or litigation record is provided, so risk timing and entry bottlenecks cannot be quantified.

What settlements or licensing deals affect DOCEFREZ exclusivity and earnings visibility?

Settlements and licensing deals can:

• accelerate or delay entry
• define launch design and carve-outs
• shift expected revenue through delayed generic uptake

No settlement or licensing terms are present in the provided information, so deal-driven trajectory cannot be reported.

Commercial outlook: how will DOCEFREZ financials likely evolve in the next 3–5 years?

A forward financial trajectory normally requires:

• historical net sales and unit volume
• gross-to-net assumptions
• indication-level adoption ramp curves
• exclusivity end dates and probability-weighted entry scenarios

None of those numeric drivers are provided. A complete, accurate financial trajectory cannot be produced without those facts.

Key Takeaways

• DOCEFREZ’s market path is governed by payer coverage, indication expansion, combination penetration, and net price durability typical for checkpoint-class oncology products.
• Exclusivity timing and patent estate breadth determine the magnitude and speed of revenue erosion once competitive entry begins.
• No Orange Book, patent, FDA milestone, or litigation record is included in the input, so a data-backed exclusivity timeline, patent map, and financial forecast cannot be generated.

FAQs

1. How does net-to-gross pricing erosion typically affect branded oncology revenue trajectories?
2. What are the main reimbursement levers that determine checkpoint inhibitor formulary access?
3. How do method-of-use patents delay generic or biosimilar entry for oncology drugs?
4. What combination approval events most often drive step-change revenue growth in oncology?
5. How should investors model sales impact in the 12–24 months leading to key exclusivity expiry?

References

1. (No sources were provided in the input.)