INBRIJA Drug Patent Profile

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

Inbrija is a drug marketed by Merz and is included in one NDA. There are six patents protecting this drug.

The generic ingredient in INBRIJA is levodopa. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levodopa profile page.

DrugPatentWatch^® Generic Entry Outlook for Inbrija

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INBRIJA

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Drug Prices:	Drug price information for INBRIJA
What excipients (inactive ingredients) are in INBRIJA?	INBRIJA excipients list
DailyMed Link:	INBRIJA at DailyMed

See drug prices for INBRIJA

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

Constraining patent/regulatory exclusivity:

8,545,878

NDA:

209184

Dosage:

POWDER;INHALATION

^*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 INBRIJA

Drug Class

Aromatic Amino Acid

US Patents and Regulatory Information for INBRIJA

INBRIJA is protected by six US patents.

This potential generic entry date is based on patent 8,545,878.

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
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	12,458,615
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	8,945,612		Y
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	RE43711
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	8,685,442		Y
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	9,393,210		Y
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	8,545,878		Y

Expired US Patents for INBRIJA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	7,182,961
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	6,514,482
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	6,921,528
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	8,404,276
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	8,628,754
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	7,146,978

EU/EMA Drug Approvals for INBRIJA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Acorda Therapeutics Ireland Limited	Inbrija	levodopa	EMEA/H/C/004786Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.	Authorised	no	no	no	2019-09-19

International Patents for INBRIJA

When does loss-of-exclusivity occur for INBRIJA?

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

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 INBRIJA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013334949
Australia	2018253538
Australia	2020250325
Brazil	112015009088
Canada	2888994
China	104884046

Supplementary Protection Certificates for INBRIJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	92782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
3209302	2023C/510	Belgium		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: BE660571 20220901
3209302	301224	Netherlands		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG128752 20221107; FIRST REGISTRATION: AT 141371 20220826
3209302	CA 2023 00015	Denmark		PRODUCT NAME: KOMBINATION AF FOSLEVODOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG FOSCARBIDOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 66549 (DK) 20221205; FIRST REG. NO/DATE: AT 141371 20220826
3209302	LUC00304	Luxembourg		PRODUCT NAME: COMBINAISON DE FOSLEVODOPA ET DE FOSCARBIDOPA, CHACUNE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; MARKETING AUTHORISATION NUMBER AND DATE: 141371, 20220826

Inbrija Market Dynamics, Revenue Trajectory, Patent Protection, and Commercial Outlook

Last updated: October 26, 2026

Inbrija, Acorda Therapeutics’ inhaled levodopa product for intermittent “OFF” episodes in Parkinson’s disease, has established a differentiated but limited commercial position. FDA approval in 2018 created the first approved inhaled levodopa rescue therapy, but sales have remained modest relative to the broader Parkinson’s drug market. Its outlook depends on specialty-neurology adoption, reimbursement, patient training, and the durability of its inhaler and formulation patents.

Acorda’s financial distress and subsequent acquisition of its commercial assets by Merz Pharma changed Inbrija’s ownership and commercial strategy. The product remains commercially relevant because it has no direct approved inhaled generic or biosimilar equivalent, although its target market is narrower than that of maintenance Parkinson’s therapies.

What is Inbrija and which patients does it treat?

Inbrija is a prescription inhalation powder containing levodopa. It is approved for the intermittent treatment of OFF episodes in adults with Parkinson’s disease who are receiving a carbidopa/levodopa regimen [1].

The product is not a replacement for oral levodopa maintenance therapy. Patients use Inbrija when motor symptoms return between scheduled doses. The product therefore competes in the on-demand or rescue-treatment segment rather than across the entire Parkinson’s disease market.

Attribute	Inbrija
Active ingredient	Levodopa
Dosage form	Inhalation powder in capsules
Delivery device	Inhaler supplied with the product
FDA approval	December 2018
Indication	Intermittent treatment of OFF episodes in Parkinson’s disease
Primary commercial market	United States specialty neurology
Original sponsor	Acorda Therapeutics
Current commercial ownership	Merz Pharma following Acorda asset transaction
Generic or biosimilar status	No approved generic inhaled equivalent identified
Main therapeutic alternatives	Oral levodopa adjustment, apomorphine products, inhaled and infusion-based rescue approaches

Inbrija’s clinical value is linked to the speed and convenience of non-oral levodopa delivery. Its commercial limitation is that many Parkinson’s patients can manage OFF episodes through changes in oral therapy, extended-release formulations, dopamine agonists, or other rescue products.

How has Inbrija revenue changed over time?

Inbrija revenue increased gradually after launch but did not reach blockbuster scale. Acorda’s public filings showed a ramp from early launch revenue into a recurring annual revenue base in the tens of millions of dollars. Growth was supported by broader physician awareness and repeat use, but constrained by reimbursement friction, patient onboarding, and the complexity of inhaler administration [2][3].

Inbrija financial trajectory

Period	Financial development	Commercial interpretation
2018	FDA approval and launch preparation	Market entry into a new rescue-levodopa category
2019	Initial commercial launch	Early uptake affected by specialty pharmacy and reimbursement processes
2020	Revenue growth continued	COVID-19 disrupted neurology visits and new-patient starts
2021	Sales reached a more established recurring base	Increased physician familiarity and patient persistence
2022	Revenue remained below large-product scale	Product retained a niche position despite continued demand
2023-2024	Ownership and commercial strategy shifted through Merz transaction	Value moved from standalone growth to portfolio integration and cost discipline

Acorda’s financial reporting indicates that Inbrija was one of the company’s two principal commercial products, alongside Ampyra. Inbrija’s contribution was meaningful to Acorda but insufficient to offset the company’s broader financing pressures, debt obligations, and declining legacy-product economics [2][3].

The key financial point is that Inbrija generated recurring product sales but not the rapid growth required to support Acorda as an independent public company. Its economics improved as fixed launch costs were spread over a larger installed patient base, yet its absolute revenue remained small compared with major Parkinson’s products such as carbidopa/levodopa combinations, Rytary, or large neurology franchises.

Why did Inbrija sales remain limited?

The eligible patient population is narrower than the Parkinson’s market

Inbrija addresses patients who:

1. Have Parkinson’s disease with clinically meaningful OFF episodes.
2. Continue to use carbidopa/levodopa.
3. Need intermittent rescue treatment.
4. Can use the inhaler correctly.
5. Obtain sufficient insurance coverage.

That funnel is materially smaller than the total population receiving levodopa. Many Parkinson’s patients never require a dedicated rescue product, and some physicians manage OFF periods through dose timing, formulation changes, or continuous delivery.

Product administration creates adoption friction

Inbrija requires patients to place capsules into the inhaler and inhale the dose. The product is not a conventional metered-dose inhaler. Patients with advanced Parkinson’s disease may have tremor, bradykinesia, dyskinesia, cognitive impairment, swallowing problems, or respiratory limitations that complicate administration.

The product label also identifies cough and upper respiratory effects as relevant tolerability considerations. Inhaled delivery may be less attractive for patients with chronic lung disease or those unable to generate adequate inspiratory effort [1].

Reimbursement affects the prescription-to-use conversion

Inbrija is generally distributed through specialty pharmacy channels. Prior authorization, copay exposure, Medicare coverage rules, and benefit design can delay or prevent initiation. A prescription does not necessarily translate into a paid shipment or sustained use.

Acorda invested in patient-support services and access programs to address these barriers. Those programs helped conversion but increased the commercial infrastructure required to sell a product with a relatively small target population.

The product competes against low-cost generic levodopa

The underlying pharmacology is familiar and inexpensive. Generic oral carbidopa/levodopa is widely available. Inbrija must therefore justify its price through speed, convenience, and rescue value rather than through a new active ingredient.

That positioning supports use in selected patients but limits pricing power across the broader Parkinson’s population.

What patents protect Inbrija?

Inbrija’s protection is based on the inhaled levodopa formulation, dosage form, inhaler system, and related delivery technology rather than on new chemical-molecule exclusivity.

Formulation and delivery protection

The commercial IP value is concentrated in claims covering:

• Levodopa inhalation powder;
• Particle engineering and aerodynamic performance;
• Capsules containing the inhalation powder;
• Dose delivery through the product-specific inhaler;
• Methods of treating OFF episodes using inhaled levodopa;
• Manufacturing processes for producing a consistent inhalable powder.

The relevant U.S. patent estate includes Acorda-related patents covering inhaled levodopa formulations and delivery systems. The exact scope and expiry dates must be evaluated patent by patent because patent-term adjustment, terminal disclaimers, continuations, and Orange Book listing practices can produce different effective dates.

Orange Book status

Inbrija is approved under NDA 209184. FDA’s Orange Book is the controlling source for patents listed against the approved product and for any future Abbreviated New Drug Application challenge [4].

A generic applicant seeking approval before listed patent expiry could file a Paragraph IV certification alleging that the listed patent is invalid, unenforceable, or not infringed. A Paragraph IV notice could trigger patent litigation and, if litigation is filed within the statutory period, a potential 30-month stay of approval under the Hatch-Waxman framework [5].

No widely commercialized generic inhaled levodopa product has displaced Inbrija. The absence of a direct generic does not eliminate future risk. An applicant could challenge formulation, device, method-of-use, or manufacturing patents individually or seek approval with a permitted labeling carve-out.

When does Inbrija lose exclusivity?

Inbrija does not have a single practical “loss of exclusivity” date.

The product has multiple layers of protection:

Protection layer	Commercial effect
FDA approval exclusivity	Limited post-approval regulatory protection, now expired
Formulation patents	May restrict equivalent inhalation powders
Device patents	May restrict use of the commercial inhaler or a substantially similar device
Method-of-use patents	May support treatment claims for OFF episodes
Manufacturing patents	Can increase development and scale-up barriers
Trade secrets and know-how	May complicate replication of particle and dose characteristics
Regulatory exclusivity for the active ingredient	Weak because levodopa is an established molecule

FDA exclusivity associated with the 2018 approval is no longer the principal barrier to generic development. Patent protection and technical complexity now determine the timing of competitive entry.

A generic may avoid some method-of-use claims through a skinny label. It would still need to demonstrate pharmaceutical equivalence, bioequivalence, inhaler performance, dose uniformity, and manufacturing consistency. Inhalation products generally present greater development complexity than conventional oral tablets.

How strong is the Inbrija patent estate?

Inbrija has a stronger barrier than a simple reformulated oral levodopa product, but its protection is not equivalent to protection for a novel chemical entity.

Strengths

• The product combines a dry-powder formulation with a dedicated delivery device.
• Inhaled levodopa performance depends on particle size, emitted dose, dispersion, and deposition.
• A generic sponsor must reproduce both the drug product and the delivery characteristics.
• Device substitution may require additional development and regulatory work.
• Manufacturing know-how can affect batch consistency and clinical performance.

Weaknesses

• Levodopa is an old active ingredient with no meaningful composition-of-matter exclusivity.
• A competitor could challenge formulation and device patents separately.
• Some method-of-use claims may be avoidable through labeling design.
• The addressable market may not justify the cost of a complex generic development program unless sales increase materially.
• Patent validity could be tested through obviousness, written-description, enablement, or claim-construction arguments.

Overall, the estate is commercially meaningful but not impenetrable. Its strongest defense is the combined formulation-device-manufacturing package, not any single levodopa patent.

What is the competitive landscape for Inbrija?

Inbrija competes across several treatment categories rather than against one direct substitute.

Competitor or alternative	Competitive relationship
Generic carbidopa/levodopa	Low-cost maintenance therapy and the foundation for Inbrija use
Rytary	Extended-release oral levodopa that may reduce OFF time
Apomorphine injection	Rapid rescue treatment with different administration and tolerability issues
Apomorphine sublingual film	Non-oral rescue alternative
Continuous levodopa infusion	Advanced therapy for selected patients with severe fluctuations
Deep brain stimulation	Device-based intervention for selected advanced patients
Duopa and other infusion approaches	Continuous dopaminergic delivery for advanced disease
Kynmobi	Former sublingual apomorphine competitor; commercial availability declined after manufacturer discontinuation

The closest commercial comparison is an apomorphine rescue product. Inbrija has the advantage of using the same active ingredient patients already know from oral levodopa therapy. Apomorphine products have different pharmacology, administration requirements, and adverse-effect profiles.

Inbrija’s principal differentiation is convenience for patients who prefer an inhaled levodopa rescue option. Its principal vulnerability is that physicians have several ways to reduce OFF time without adding an inhaled product.

What litigation and licensing issues affect Inbrija?

Acorda’s corporate restructuring is more important to Inbrija’s commercial history than publicly prominent patent litigation. Acorda entered Chapter 11 proceedings in 2023 after prolonged financial pressure. Merz acquired Acorda’s commercial assets, including Inbrija, through a transaction that transferred operating control and product rights [6].

The transaction changed the economic owner of the product but did not eliminate Inbrija’s regulatory or patent obligations. Merz’s rationale was portfolio ownership and operational integration rather than a large-scale standalone growth investment.

Publicly disclosed commercial considerations include:

• Transfer of Inbrija rights and related assets to Merz;
• Continuation of product supply and commercialization;
• Management of manufacturing and specialty-distribution relationships;
• Preservation of patient access during the ownership transition;
• Potential cost reductions from operating the product within a larger pharmaceutical organization.

No confirmed, market-displacing Paragraph IV settlement has established an earlier generic entry date for Inbrija. Any future settlement would be material because even a single inhaled generic could pressure price, specialty-pharmacy volume, and the product’s residual valuation.

What FDA regulatory factors affect Inbrija’s future?

The FDA pathway for a generic Inbrija would likely require more than a conventional tablet comparison. The applicant would need to address:

• Active ingredient and dosage strength;
• Delivered dose;
• Particle-size distribution;
• Aerodynamic particle-size distribution;
• Emitted dose and fine-particle fraction;
• Device performance;
• Capsule compatibility;
• Pharmacokinetic comparability;
• Manufacturing controls;
• Labeling and use of any permitted carve-outs.

The FDA’s regulatory treatment of complex inhalation products can create development uncertainty. That uncertainty supports Inbrija’s commercial protection even after conventional regulatory exclusivity ends.

Biosimilar risk is not relevant. Inbrija is a small-molecule levodopa product, not a biologic. The relevant competitive pathway is an ANDA or, depending on product differences, another small-molecule regulatory route.

What generic launch scenarios exist for Inbrija?

Scenario 1: No generic before late patent expiry

This is the most favorable outcome for Merz. Inbrija retains a protected niche, with revenue driven by patient retention, physician prescribing, and improved reimbursement.

Scenario 2: A single complex generic launches after patent litigation

A first generic could receive a period of commercial advantage, particularly if it uses a compatible inhaler or wins a patent challenge. Price erosion would depend on substitution mechanics and payer coverage.

Scenario 3: Authorized or licensed competition

The product owner could license manufacturing, device technology, or regional rights. This could expand geographic reach but would reduce per-unit economics.

Scenario 4: Label-limited generic entry

A generic could enter with certain method-of-use indications carved out. That would create partial competition while leaving some branded use protected.

The commercial impact of generic entry would likely be lower than for a mass-market oral tablet because of the small patient population and complex device. The revenue decline could still be severe if payers substitute the generic broadly.

How does Inbrija compare with other Parkinson’s products?

Inbrija’s value is strongest when measured against rescue-treatment needs, not total Parkinson’s drug sales.

Metric	Inbrija	Oral levodopa products	Apomorphine rescue
Core use	Intermittent OFF episodes	Baseline symptom control	Rapid rescue
Administration	Inhaled powder	Oral	Injection, sublingual, or other non-oral form
Active ingredient familiarity	High	High	Lower for many levodopa-treated patients
Generic pressure	Moderate future risk	Extensive	Product-specific
Patient training	Required	Limited	Often substantial
Market size	Niche	Very large	Niche
Price competition	Moderate	High	Moderate to high
Patent value	Formulation and device	Often limited	Formulation, device, or delivery

Inbrija is better positioned as a durable specialty product than as a high-growth mass-market drug. Its commercial ceiling is constrained by the number of patients who experience clinically significant OFF episodes and can use the device.

What is the commercial outlook and revenue exposure?

Merz inherited a product with established demand, a differentiated delivery route, and no direct generic competitor at the time of the ownership transition. The financial case is based on preserving and modestly expanding a recurring specialty-neurology franchise.

Revenue upside depends on:

• Increasing physician recognition of inhaled levodopa;
• Expanding use among appropriate OFF-episode patients;
• Reducing prior-authorization friction;
• Improving patient training and adherence;
• Maintaining payer coverage;
• Extending patent and device protection;
• Controlling manufacturing and patient-support costs.

Revenue downside risks include:

• Generic or follow-on inhaled competition;
• Lower reimbursement;
• Device discontinuation or supply disruption;
• Patient inability to use the inhaler;
• Alternative rescue products;
• Clinical preference for oral dose adjustment or infusion therapy;
• Declining investment in a small product within a larger portfolio.

The product’s revenue exposure is material to the Inbrija franchise but limited in the context of Merz’s diversified pharmaceutical portfolio. For Acorda, Inbrija was strategically important because the company depended on a small number of commercial products. For Merz, it is more likely to be evaluated on contribution margin, portfolio fit, and long-term specialty-market retention.

Key Takeaways

• Inbrija is an FDA-approved inhaled levodopa product for intermittent OFF episodes in Parkinson’s disease.
• Its commercial opportunity is a specialty rescue market, not the full Parkinson’s levodopa market.
• Sales grew after the 2018 launch but remained in the tens-of-millions-of-dollars range rather than reaching blockbuster scale.
• Acorda’s financial distress led to a transfer of Inbrija assets to Merz.
• The product’s main protection comes from formulation, inhaler, manufacturing, and method-of-use patents.
• FDA exclusivity is no longer the principal barrier to competition.
• No biosimilar risk exists because Inbrija is a small-molecule drug.
• Future generic risk is technically meaningful but moderated by inhaler complexity and the limited market size.
• The strongest commercial risks are reimbursement friction, patient usability, alternative rescue therapies, and eventual complex-generic entry.
• Inbrija is best characterized as a durable niche neurology asset with moderate patent support and limited blockbuster potential.

FAQs

Is Inbrija still protected by patents?

Yes. Its remaining protection is tied primarily to inhaled levodopa formulation, inhaler-device, manufacturing, and method-of-use patents. The effective protection period depends on the specific listed patents and any applicable patent-term adjustments or disclaimers.

Can a generic company make an inhaled levodopa product?

Yes, in principle. A generic sponsor would need to demonstrate pharmaceutical equivalence, comparable inhalation performance, dose delivery, and manufacturing consistency. Patent litigation could delay approval or commercial launch.

Is Inbrija a biologic subject to biosimilar competition?

No. Inbrija contains levodopa, a small-molecule active ingredient. Any direct competitor would generally use a generic-drug pathway rather than the biosimilar pathway.

Who owns Inbrija now?

Merz acquired Acorda’s commercial assets, including Inbrija, through Acorda’s restructuring and asset-sale process. Merz is responsible for the product’s commercial ownership and portfolio management.

What is the largest threat to Inbrija revenue?

The largest near-term risks are limited patient adoption, reimbursement barriers, and competition from other approaches to managing OFF episodes. The largest long-term risk is a generic or follow-on inhaled levodopa product that achieves payer substitution.

References

1. U.S. Food and Drug Administration. (2018). Inbrija prescribing information. FDA.
2. Acorda Therapeutics, Inc. (2022). Annual report on Form 10-K for the fiscal year ended December 31, 2022. U.S. Securities and Exchange Commission.
3. Acorda Therapeutics, Inc. (2023). Annual report and financial filings. U.S. Securities and Exchange Commission.
4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.
5. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355.
6. Merz Pharma GmbH & Co. KGaA. (2023). Merz completes acquisition of Acorda Therapeutics’ commercial assets. Merz corporate disclosures.