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As of 13 November 2026, for Rotigotine Patches, 7 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 4 applicationsNo longer listed under review: 2 applicationsSupplement delivery: 2 applications
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders1View records ↓
Under-review filings7View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers7View records ↓
API companies with A status8View records ↓
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| UCB Pharma S.A. | LTS Lohmann Therapie-Systeme AG | H20180026 | 2018/06/08 | See source | Imported originator drug | CDE |
| UCB Pharma S.A. | LTS Lohmann Therapie-Systeme AG | H20180029 | 2018/06/08 | See source | Imported originator drug | CDE |
| UCB Pharma S.A. | LTS Lohmann Therapie-Systeme AG | H20180027 | 2018/06/08 | See source | Imported originator drug | CDE |
| UCB Pharma S.A. | LTS Lohmann Therapie-Systeme AG | H20180028 | 2018/06/08 | See source | Imported originator drug | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 7 distinct approval numbers and 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Tai De Pharmaceutical Co., Ltd. romanized | 国药准字H20256034 | See source | Not stated by source | XN04BCL368V001010100156 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20255693 | See source | Not stated by source | XN04BCL368V001010102180 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20255693 | See source | Not stated by source | XN04BCL368V001010202180 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180029 | See source | Not stated by source | XN04BCL368V001010278930 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180029 | See source | Not stated by source | XN04BCL368V001010378930 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20255694 | See source | Not stated by source | XN04BCL368V001020102180 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20255694 | See source | Not stated by source | XN04BCL368V001020202180 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180026 | See source | Not stated by source | XN04BCL368V001020278930 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180028 | See source | Not stated by source | XN04BCL368V001030278930 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180027 | See source | Not stated by source | XN04BCL368V001040378930 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180027 | See source | Not stated by source | XN04BCL368V001040478930 | NHSA |
| UCB Pharma S.A. | 国药准字HJ20180027 | See source | Not stated by source | XN04BCL368V001040578930 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 7 filings and 3 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2602177 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2602176 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2602175 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2602053 | Generic | 2026/08/19 | Not stated by source | CDE |
| Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601323 | Generic | 2026/06/08 | Not stated by source | CDE |
| Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601322 | Generic | 2026/06/08 | Not stated by source | CDE |
| Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601321 | Generic | 2026/06/08 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 7 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2602177 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2602176 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2602175 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2602053 | Generic | 2026/08/19 | Not stated by source | CDE |
| Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601323 | Generic | 2026/06/08 | Not stated by source | CDE |
| Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601322 | Generic | 2026/06/08 | Not stated by source | CDE |
| Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2601321 | Generic | 2026/06/08 | Not stated by source | CDE |
API registrations
Non-component matches: 8 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 罗替高汀 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20250001352 | I | Exact ingredient | 2026/01/07 | CDE |
| 罗替高汀 · No verified English name | Hunan Ou Ya Pharma Co., Ltd. romanized | Y20240001515 | A | Exact ingredient | 2026/07/14 | CDE |
| 罗替高汀 · No verified English name | Cheng Hong Pharmaceutical (Wei Hai) Co., Ltd. romanized | Y20240001484 | A | Exact ingredient | 2026/06/24 | CDE |
| 罗替高汀 · No verified English name | Shandong Ke Yuan Pharmaceutical Co., Ltd. romanized | Y20240001227 | A | Exact ingredient | 2026/09/07 | CDE |
| 罗替高汀 · No verified English name | Hebei Ding Tai Pharmaceutical Co., Ltd. romanized | Y20230001320 | A | Exact ingredient | 2025/08/14 | CDE |
| 罗替高汀 · No verified English name | Viyash Life Sciences Private Limited Unit-I | Y20230000342 | I | Exact ingredient | 2023/06/08 | CDE |
| 罗替高汀 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20230000434 | A | Exact ingredient | 2026/02/10 | CDE |
| 罗替高汀 · No verified English name | Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20230000313 | A | Exact ingredient | 2026/06/16 | CDE |
| 罗替高汀 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20220000642 | A | Exact ingredient | 2024/07/17 | CDE |
| 罗替高汀 · No verified English name | Zhejiang Rui Bo Pharmaceutical Co., Ltd. romanized | Y20210001298 | A | Exact ingredient | 2025/11/11 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/10/23No longer listed under review
Beijing Tai De Pharmaceutical Co., Ltd. romanized
CYHB2502584
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/12/26
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/23 (approval no.: 国药准字H20269258; approval date: 2026/10/21); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 5
NMPA · Table row 5 ↗ View source ↗ -
2026/10/23No longer listed under review
Beijing Tai De Pharmaceutical Co., Ltd. romanized
CYHB2502583
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/12/26
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/23 (approval no.: 国药准字H20269257; approval date: 2026/10/21); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 4
NMPA · Table row 4 ↗ View source ↗ -
2026/10/21Supplement delivery
Beijing Tai De Pharmaceutical Co., Ltd. romanized
CYHB2502584 · 国药准字H20269258
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 5 ↗ -
2026/10/21Supplement delivery
Beijing Tai De Pharmaceutical Co., Ltd. romanized
CYHB2502583 · 国药准字H20269257
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 4 ↗ -
2026/10/20Marketing application approved
Beijing Foyou Pharma CO.,LTD
CYHS2501325 · 国药准字H20266348
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 49 ↗ -
2026/09/01Accepted
Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
CYHS2602177
Fact date: 2026/09/01 · Site observation date: 2026/10/22
View source ↗ -
2026/09/01Accepted
Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
CYHS2602176
Fact date: 2026/09/01 · Site observation date: 2026/10/22
View source ↗ -
2026/09/01Accepted
Hangzhou Huang Sen Bio Technology Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized
CYHS2602175
Fact date: 2026/09/01 · Site observation date: 2026/10/22
View source ↗ -
2026/08/19Accepted
Hunan Jiudian Pharmaceutical Co., Ltd
CYHS2602053
Fact date: 2026/08/19 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/13 06:41
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
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.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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