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Budesonide Nasal Spray

Matched
Active ingredients (original)
BUDESONIDE
Dosage form (original)
SPRAY, METERED
Route (original)
NASAL

Read these limits

  1. US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
  2. The Orange Book lists holder-submitted patents and does not cover all related patents.
  3. “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
  4. This page contains no sales or market-size data and cannot establish development value.
  5. Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.

US-approved products

Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.

Earliest approval2015/03/23
ANDA applications1
RLD applicantKENVUE BRANDS LLC

Currently marketed products: 2 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.

Application / product numberBrand name (original)Applicant (original)Dosage form (original)Route (original)Strength (original)Earliest approvalRLD / RSMarketing status (original)Official source
A078949-002BUDESONIDEAPOTEX INCSPRAY, METEREDNASALBUDESONIDE: 0.032MG/SPRAY2015/11/20N / NHUMAN OTC DRUGopenFDA ↗
N020746-003RHINOCORT ALLERGYKENVUE BRANDS LLCSPRAY, METEREDNASALBUDESONIDE: 0.032MG/SPRAY2015/03/23Y / YHUMAN OTC DRUGopenFDA ↗

Listed US patents

*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.

Latest listed patent expiration—
Substance patent expiration (DS flag)—

This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.

Application / product numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
Not listed

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: —

Application / product numberExclusivity codeListed expirationOfficial source
Not listed

Chinese record details

Chinese product landscape ↗

The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.

Catalog holders 1

Company (original)Identifier (original)Source dateOfficial source
McNeil Sweden ABH20171309;H20171310See source2002/02/21Official source ↗
McNeil Sweden ABH20171311;H20171312See source2002/02/21Official source ↗

NHSA approval numbers 13

Company (original)Identifier (original)Source dateOfficial source
McNeil Sweden AB国药准字J20180024See source—Official source ↗
Yuan Da Jiu He (Jiangxi) Pharma Co., Ltd. romanized国药准字H20234500See source—Official source ↗
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字J20190031See source—Official source ↗
McNeil Sweden AB国药准字HJ20171309See source—Official source ↗
Sichuan Pu Rui Te Pharma Co., Ltd. romanized国药准字H20234511See source—Official source ↗
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字HC20181007See source—Official source ↗
McNeil Sweden ABH20171310See source—Official source ↗
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字HC20191008See source—Official source ↗
McNeil Sweden AB国药准字J20180023See source—Official source ↗
Yuan Da Jiu He (Jiangxi) Pharma Co., Ltd. romanized国药准字H20234507See source—Official source ↗
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字J20190031See source—Official source ↗
McNeil Sweden AB国药准字HJ20171311See source—Official source ↗
Sichuan Pu Rui Te Pharma Co., Ltd. romanized国药准字H20234512See source—Official source ↗
Taiwan Hai Mo Ni Pharma Co., Ltd. romanized国药准字HC20181007See source—Official source ↗
McNeil Sweden ABH20171312See source—Official source ↗

Under review 3

Company (original)Identifier (original)Source dateOfficial source
Jewim Pharmaceutical (Shandong) Co., Ltd.CYHS26024412026/10/08Official source ↗
Zhang Feng Pharma Co., Ltd. romanizedCYHS26002732026/01/24Official source ↗
Zhang Feng Pharma Co., Ltd. romanizedCYHS26002722026/01/24Official source ↗

Generic-filing companies this year 2

Company (original)Identifier (original)Source dateOfficial source
Jewim Pharmaceutical (Shandong) Co., Ltd.CYHS26024412026/10/08Official source ↗
Zhang Feng Pharma Co., Ltd. romanizedCYHS26002732026/01/24Official source ↗
Zhang Feng Pharma Co., Ltd. romanizedCYHS26002722026/01/24Official source ↗

API companies with A status 21

Company (original)Identifier (original)Source dateOfficial source
Ao Rui Te Pharma Co., Ltd. romanizedY202500003902026/10/14Official source ↗
Zhejiang Shen Zhou Pharma Co., Ltd. romanizedY202500001792026/09/29Official source ↗
Sichuan Ren An Pharma Co., Ltd. romanizedY202400002382025/07/25Official source ↗
Aspen Oss B.V.Y202300000132025/08/06Official source ↗
Xin Xiang Hai Bin Pharma Co., Ltd. romanizedY202200011612024/05/29Official source ↗
Bo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanizedY202200010422026/07/08Official source ↗
Bo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanizedY202200010412024/12/27Official source ↗
Shandong Si Rui Pharma Co., Ltd. romanizedY202200009802026/08/22Official source ↗
Hebei Chuang Jian Pharma Co., Ltd. romanizedY202200006132024/04/25Official source ↗
Xin Xiang Hai Bin Pharma Co., Ltd. romanizedY202200002352024/01/16Official source ↗
INDUSTRIALE CHIMICA SRLY202200000282025/01/28Official source ↗
FARMABIOS S.P.A.Y202100011462024/12/31Official source ↗
Avik Pharmaceutical LtdY202100007762025/01/15Official source ↗
Newchem S.p.A.Y202000011612025/06/21Official source ↗
Henan Li Hua Pharmaceutical Co., Ltd. romanizedY202000014062024/02/24Official source ↗
Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY201900098862024/09/03Official source ↗
Jin Yao Pharma Co., Ltd. romanizedY201900088522026/01/24Official source ↗
Lu Nan Bei Te Pharmaceutical Co., Ltd. romanizedY201900036902025/03/11Official source ↗
Shanghai Xin Yi Bai Lu Da Pharma Co., Ltd. romanizedY201900014902025/01/23Official source ↗
MINAKEMY201800016682026/06/13Official source ↗
Shandong Rui Shun Pharma Co., Ltd. romanizedY201700014632025/04/16Official source ↗
VAMSI LABS LTD.Y201700009752025/07/20Official source ↗
Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY201700009712023/03/24Official source ↗

Trial registrations 2025/2026 —

Not loaded

Sources and dates

FDA Orange Book
2026/11/06
CDE acceptance and review
2026/11/13 06:42
Chemical Drug Catalog
2026/11/13 06:39
API registration records
2026/11/13 06:41
NHSA drug code database
2026/10/23
Trial registry
2026/11/13 08:09 · Incomplete coverage

Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.

Formulation crosswalk to SPRAY, METERED / NASAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-096. Chinese Pharmacopoeia general chapter 0106

Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗

Name and dosage-form matching sources