Product profile · United States

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· Patent Litigation & Settlement History ↓

IngredientDOXYCYCLINE HYCLATE

Application typeNDA

Application205931

Product001

Dosage formTABLET

RouteORAL

StrengthEQ 75MG BASE

Approval date2014-07-25

Marketing statusPrescription

Status event—

ApplicantCHARTWELL RX

Product source

Current GenericRadar decision

Year2017

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2017-06-14

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2017-06-14

Status event—

Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
No patent facts are recorded for this product.

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
208765 / 001	FINAL_APPROVAL · FINAL_APPROVED	2017-06-14	—	DR REDDYS LABORATORIES SA	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
208818 / 001	FINAL_APPROVAL · FINAL_APPROVED	2017-09-27	—	LUPIN LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209372 / 001	FINAL_APPROVAL · FINAL_APPROVED	2017-10-06	—	AMNEAL PHARMACEUTICALS CO GMBH	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209243 / 001	FINAL_APPROVAL · FINAL_APPROVED	2019-04-15	—	APOTEX INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211584 / 001	FINAL_APPROVAL · FINAL_APPROVED	2020-06-01	—	AJANTA PHARMA LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211744 / 001	FINAL_APPROVAL · FINAL_APPROVED	2020-06-30	—	ALEMBIC PHARMACEUTICALS LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209987 / 001	FINAL_APPROVAL · FINAL_APPROVED	2020-10-05	—	RISING PHARMA HOLDING INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214207 / 001	FINAL_APPROVAL · FINAL_APPROVED	2020-12-16	—	EPIC PHARMA LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214356 / 001	FINAL_APPROVAL · FINAL_APPROVED	2024-04-15	—	TORRENT PHARMACEUTICALS LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 9 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
208765 / 001	DR REDDYS LABORATORIES SA	FINAL_APPROVAL · FINAL_APPROVED	2017-06-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
208818 / 001	LUPIN LTD	FINAL_APPROVAL · FINAL_APPROVED	2017-09-27	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209372 / 001	AMNEAL PHARMACEUTICALS CO GMBH	FINAL_APPROVAL · FINAL_APPROVED	2017-10-06	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209243 / 001	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVED	2019-04-15	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211584 / 001	AJANTA PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2020-06-01	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211744 / 001	ALEMBIC PHARMACEUTICALS LTD	FINAL_APPROVAL · FINAL_APPROVED	2020-06-30	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209987 / 001	RISING PHARMA HOLDING INC	FINAL_APPROVAL · FINAL_APPROVED	2020-10-05	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214207 / 001	EPIC PHARMA LLC	FINAL_APPROVAL · FINAL_APPROVED	2020-12-16	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214356 / 001	TORRENT PHARMACEUTICALS LTD	FINAL_APPROVAL · FINAL_APPROVED	2024-04-15	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
GENERIC	2017-06-14	TERMINAL_GENERIC_BASIS	Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.