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SIVEXTRO Drug Patent Profile

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When do Sivextro patents expire, and what generic alternatives are available?

Sivextro is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this drug.

This drug has seventy-eight patent family members in thirty-nine countries.

The generic ingredient in SIVEXTRO is tedizolid phosphate. Two suppliers are listed for this compound. Additional details are available on the tedizolid phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Sivextro

Sivextro was eligible for patent challenges on June 20, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 31, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SIVEXTRO

International Patents:	78
US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	5
Patent Applications:	88
Drug Prices:	Drug price information for SIVEXTRO
What excipients (inactive ingredients) are in SIVEXTRO?	SIVEXTRO excipients list
DailyMed Link:	SIVEXTRO at DailyMed

Drug patent expirations by year for SIVEXTRO

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

Generic Entry Dates for SIVEXTRO^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,426,389 NDA: 205436 Dosage: POWDER;INTRAVENOUS
Generic Entry Dates for SIVEXTRO^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,426,389 NDA: 205435 Dosage: TABLET;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.

Recent Clinical Trials for SIVEXTRO

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2
Los Angeles Biomedical Research Institute	Phase 2

See all SIVEXTRO clinical trials

Pharmacology for SIVEXTRO

Drug Class	Oxazolidinone Antibacterial
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors

US Patents and Regulatory Information for SIVEXTRO

SIVEXTRO is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIVEXTRO is ⤷ Subscribe.

This potential generic entry date is based on patent 8,426,389.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	8,426,389	⤷ Subscribe	Y	Y		⤷ Subscribe
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	10,065,947	⤷ Subscribe	Y			⤷ Subscribe
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	9,624,250	⤷ Subscribe	Y	Y		⤷ Subscribe
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	7,816,379	⤷ Subscribe	Y	Y		⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for SIVEXTRO

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Sivextro	tedizolid phosphate	EMEA/H/C/002846 Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.	Authorised	no	no	no	2015-03-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SIVEXTRO

When does loss-of-exclusivity occur for SIVEXTRO?

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

African Regional IP Organization (ARIPO)

Patent: 87
Patent: Crystalline form of (R)-3-(-4(2-(2-methyltetrazol-5-YL)pyridin-5-YL)-3-fluorophenyl)-5-hydroxymethyloxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷ Subscribe

Australia

Patent: 10210627
Patent: Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷ Subscribe

Brazil

Patent: 1008829
Patent: forma cristalina de dihidrogenofosfato de (r)-3-(4-(2-(2-metiltetrazol-5-il) piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona
Estimated Expiration: ⤷ Subscribe

Canada

Patent: 51392
Patent: FORME CRISTALLINE DU DIHYDROGENOPHOSPHATE DE (R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE)
Estimated Expiration: ⤷ Subscribe

Chile

Patent: 11001855
Patent: Partículas cristalinas que comprenden al compuesto fosfato de dihidrógeno de (r)-3-(4-(2-(2-metiltetrazol-5-il)piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona; proceso de preparación; mezcla que la comprende; composición farmacéutica; y su uso para tratar una infección bacteriana.
Estimated Expiration: ⤷ Subscribe

China

Patent: 2439006
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷ Subscribe

Patent: 7082790
Patent: 种噁唑烷酮化合物的晶型 (Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷ Subscribe

Colombia

Patent: 20071
Patent: Forma cristalina del fosfato de dihidrogeno r)-3-(4-(2-(2-metiltetrazol-5-il)piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona
Estimated Expiration: ⤷ Subscribe

Costa Rica

Patent: 110464
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5- HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷ Subscribe

Cuba

Patent: 089
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDRÓGENO R)-3-(4-(2-(2-METILTRETAZOL-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷ Subscribe

Patent: 110155
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDRÓGENO R)-3-(4-(2-(2-METILTRETAZOL-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷ Subscribe

Dominican Republic

Patent: 011000251
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL) PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷ Subscribe

Ecuador

Patent: 11011285
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷ Subscribe

European Patent Office

Patent: 93808
Patent: FORME CRISTALLINE DU DIHYDROGÉNOPHOSPHATE DE (R)-3-(4-(2-(2-MÉTHYLTÉTRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHÉNYL)-5-HYDROXYMÉTHYL OXAZOLIDIN-2-ONE (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE)
Estimated Expiration: ⤷ Subscribe

Israel

Patent: 4401
Patent: צורה גבישית של (r)-3-(4-(2-(2-מתילטטראזול-5-יל)פירידין-5-יל)-3-פלואורופניל)-5-הידרוקסימתיל אוקסאזולידין-2-און דיהידרוגן פוספאט (Crystalline form of (r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷ Subscribe

Japan

Patent: 84705
Estimated Expiration: ⤷ Subscribe

Patent: 12516894
Estimated Expiration: ⤷ Subscribe

Malaysia

Patent: 6354
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

Mexico

Patent: 11008093
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTET RAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA. (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-Y L)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE.)
Estimated Expiration: ⤷ Subscribe

Patent: 20011773
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTET RAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA. (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-Y L)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE.)
Estimated Expiration: ⤷ Subscribe

Morocco

Patent: 092
Patent: FORME CRISTALLINE DU DIHYDROGÉNOPHOSPHATE DE (R)-3-(4-(2-(2-MÉTHYLTÉTRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHÉNYL)-5-HYDROXYMÉTHYL OXAZOLIDIN-2-ONE
Estimated Expiration: ⤷ Subscribe

New Zealand

Patent: 4408
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷ Subscribe

Patent: 0458
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷ Subscribe

Patent: 2289
Patent: Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Estimated Expiration: ⤷ Subscribe

Peru

Patent: 120585
Patent: FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL) PIRIDIN-5-IL)-3-FLUOROFENSIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Estimated Expiration: ⤷ Subscribe

Philippines

Patent: 014500092
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

Russian Federation

Patent: 55928
Patent: Кристаллические частицы для приготовления твердых лекарственных форм для лечения бактериальных инфекций, реакционная смесь, содержащая такие частицы, и фармацевтическая композиция для лечения бактериальных инфекций (CRYSTALLINE PARTICLES FOR PREPARATION OF SOLID DOSAGE FORMS FOR TREATMENT OF BACTERIAL INFECTIONS, REACTION MIXTURE CONTAINING SUCH PARTICLES, AND PHARMACEUTICAL COMPOSITION FOR TREATING BACTERIAL INFECTIONS)
Estimated Expiration: ⤷ Subscribe

Patent: 11136537
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА (R)-3-(4-(2-МЕТИЛТЕТРАЗОЛ-5-ИЛ)ПИРИДИН-5-ИЛ)-3-ФТОРФЕНИЛ)-5-ГИДРОКСИМЕТИЛ ОКСАЗОЛИДИН-2-ОН ДИВОДОРОД ФОСФАТА
Estimated Expiration: ⤷ Subscribe

Singapore

Patent: 3497
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

Patent: 201500207Q
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

South Africa

Patent: 1106412
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

Patent: 1306536
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

South Korea

Patent: 1739923
Estimated Expiration: ⤷ Subscribe

Patent: 1918678
Estimated Expiration: ⤷ Subscribe

Patent: 110120311
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

Patent: 170040371
Patent: Ｒ)-3--5-히드록시메틸 옥사졸리딘-2-온 디히드로겐 포스페이트의 결정형 (-3-4-2-2--5--5--3--5- -2- Crystalline form of R-3-4-2-2-methyltetrazol-5-ylpyridin-5-yl-3-fluorophenyl-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷ Subscribe

Patent: 170135984
Patent: Ｒ)-3--5-히드록시메틸 옥사졸리딘-2-온 디히드로겐 포스페이트의 결정형 (-3-4-2-2--5--5--3--5- -2- Crystalline form of R-3-4-2-2-methyltetrazol-5-ylpyridin-5-yl-3-fluorophenyl-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate)
Estimated Expiration: ⤷ Subscribe

Spain

Patent: 34724
Estimated Expiration: ⤷ Subscribe

Tunisia

Patent: 11000381
Patent: CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Estimated Expiration: ⤷ Subscribe

Ukraine

Patent: 4068
Patent: КРИСТАЛІЧНІ ЧАСТИНКИ (R)-3-(4-(2-(2-МЕТИЛТЕТРАЗОЛ-5-ІЛ)ПІРИДИН-5-ІЛ)-3-ФТОРФЕНІЛ)-5-ГІДРОКСИМЕТИЛОКСАЗОЛІДИН-2-ОНДИВОДЕНЬФОСФАТУ
Estimated Expiration: ⤷ Subscribe

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 SIVEXTRO around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	100854211		⤷ Subscribe
Ecuador	SP11011285		⤷ Subscribe
Russian Federation	2414469	НОВЫЕ ПРОИЗВОДНЫЕ ОКСАЗОЛИДИНОНА (NOVEL OXAZOLIDINONE DERIVATIVES)	⤷ Subscribe
China	101982468	Novel oxazolidinone derivatives and pharmaceutical compositions comprising the derivatives	⤷ Subscribe
Austria	514686		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SIVEXTRO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	52/2015	Austria	⤷ Subscribe	PRODUCT NAME: TEDIZOLID, WAHLWEISE IN DER FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	C20150036 00229	Estonia	⤷ Subscribe	PRODUCT NAME: TEDISOLIIDFOSFAAT;REG NO/DATE: EU/1/15/991 25.03.2015
1699784	CA 2015 00048	Denmark	⤷ Subscribe	PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TEDIZOLID PHOSPHATE; REG. NO/DATE: EU/1/15/991 20150325
1699784	2015/048	Ireland	⤷ Subscribe	PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	132016000024232	Italy	⤷ Subscribe	PRODUCT NAME: TEDIZOLID, FACOLTATIVAMENTE IN FORMA DI ESTERE, IN PARTICOLARE UN FOSFATO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SIVEXTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/991/001, 20150325
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

SIVEXTRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SIVEXTRO

Introduction

SIVEXTRO (tedizolid phosphate) is an oxazolidinone-class antibacterial drug developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Here, we will delve into the market dynamics and financial trajectory of SIVEXTRO, highlighting key milestones, financial performance, and future prospects.

Market Approval and Launch

SIVEXTRO received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2015, paving the way for its approval in Europe[4].

Ownership and Commercialization

Initially developed by Cubist Pharmaceuticals, SIVEXTRO was acquired by Merck as part of its purchase of Cubist Pharmaceuticals. However, in recent years, Nabriva Therapeutics has taken over the commercialization of SIVEXTRO, launching its own National Drug Code (NDC) for the drug in April 2021[1][2].

Sales Performance

Historical Sales

SIVEXTRO has shown significant growth since its transition to Nabriva Therapeutics. The company reported that SIVEXTRO sales were on track to return to historical peak levels by mid-2022. This growth was driven by continued prescription increases, with a 5% year-over-year growth in the fourth quarter of 2021 and sequential quarterly prescription growth for three consecutive quarters[1][2].

Quarterly and Annual Revenue

In the fourth quarter of 2021, SIVEXTRO sales contributed $8.2 million to the total revenue of $9.3 million, representing a significant portion of Nabriva Therapeutics' revenue. For the full year 2021, SIVEXTRO product revenue netted $23.8 million, a substantial increase from the previous year[2].

Financial Impact

Revenue Growth

The launch of SIVEXTRO under Nabriva Therapeutics' own NDC in April 2021 was a pivotal moment, leading to a $23.8 million increase in product revenue for 2021 compared to 2020. This growth contributed to a total revenue of $28.9 million for the year 2021, up from $5.0 million in 2020[2].

Cost of Revenues

The cost of revenues increased significantly in the fourth quarter of 2021, primarily due to the launch of Nabriva's own NDC for SIVEXTRO. This increase was $4.9 million higher than the same period in 2020, reflecting the operational costs associated with the new NDC[2].

Cash Runway and Financial Stability

As of December 31, 2021, Nabriva Therapeutics had $47.7 million in cash, cash equivalents, and short-term investments. The strong close to 2021, driven by SIVEXTRO sales, extended the company's cash runway well into the fourth quarter of 2022, ensuring sufficient funds for operational expenses, debt service, and capital expenditures[1][2].

Market Dynamics

Competitive Landscape

SIVEXTRO operates in a competitive market for antibacterial drugs. However, its unique profile as an oxazolidinone-class antibiotic with both intravenous and oral administration options sets it apart. The drug's comparative added clinical benefit has been a key factor in its market performance, as markets tend to reward drugs with significant clinical benefits[3].

Regulatory Environment

Regulatory approvals and partnerships have been crucial for SIVEXTRO's market dynamics. The positive opinion from the CHMP and subsequent approvals in various regions have facilitated its commercial success. Additionally, partnerships such as the contract with Vizient Health have enhanced access to the drug[1][4].

Future Prospects

Growth Strategies

Nabriva Therapeutics is focused on driving further growth for SIVEXTRO through several strategies:

Geographic Expansion: Expanding commercialization and distribution partnerships globally.
Educational Efforts: Educating the medical community on the benefits of SIVEXTRO.
Life-Cycle Management: Exploring additional indications and life-cycle management opportunities[1][2].

Challenges and Opportunities

Despite the positive trajectory, the company faces challenges such as the ongoing impact of the COVID-19 pandemic on commercial activities. However, the pandemic has also highlighted the need for effective antibacterial treatments, presenting opportunities for growth and market penetration[1].

Key Takeaways

Strong Sales Growth: SIVEXTRO sales are returning to historical peak levels, driven by increased prescriptions and effective commercial strategies.
Financial Stability: The drug's performance has extended Nabriva Therapeutics' cash runway into the fourth quarter of 2022.
Market Dynamics: SIVEXTRO's unique clinical benefits and regulatory approvals have positioned it favorably in the competitive antibacterial market.
Future Prospects: Continued growth is anticipated through geographic expansion, educational efforts, and life-cycle management.

FAQs

What is SIVEXTRO used for?

SIVEXTRO (tedizolid phosphate) is used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Who currently commercializes SIVEXTRO?

Nabriva Therapeutics currently commercializes SIVEXTRO after launching its own National Drug Code (NDC) in April 2021.

How has SIVEXTRO's sales performance been in recent years?

SIVEXTRO sales have shown significant growth, with a 5% year-over-year increase in the fourth quarter of 2021 and sequential quarterly prescription growth for three consecutive quarters.

What are the key financial highlights for SIVEXTRO in 2021?

In 2021, SIVEXTRO contributed $23.8 million to Nabriva Therapeutics' product revenue, and the company reported a total revenue of $28.9 million for the year.

What are the future growth strategies for SIVEXTRO?

Nabriva Therapeutics plans to drive further growth through geographic expansion, educational efforts, and life-cycle management opportunities.

Sources

Nabriva Therapeutics Provides Business Update and Announces Preliminary Financial Results for the Fourth Quarter of 2021 - Biospace
Nabriva Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update - GlobeNewswire
Antimicrobial Drugs Market Returns Analysis - ASPE
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