DOXYCHEL Drug Patent Profile

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

Doxychel is a drug marketed by Rachelle and is included in two NDAs.

The generic ingredient in DOXYCHEL is doxycycline hyclate. There are two drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Doxychel

A generic version of DOXYCHEL was approved as doxycycline hyclate by STRIDES PHARMA on March 29^th, 1982.

Summary for DOXYCHEL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	2,745
DailyMed Link:	DOXYCHEL at DailyMed

Recent Clinical Trials for DOXYCHEL

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3
University of Washington	Phase 3

See all DOXYCHEL clinical trials

US Patents and Regulatory Information for DOXYCHEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rachelle	DOXYCHEL	doxycycline	FOR SUSPENSION;ORAL	061720-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Rachelle	DOXYCHEL HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	061953-001	Approved Prior to Jan 1, 1982		DISCN	No	No

EU/EMA Drug Approvals for DOXYCHEL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Doxirobe	Doxycycline	EMEA/V/C/000044Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy.	Withdrawn	no	no	no	1999-09-16

Last updated: July 8, 2026

Doxychel Market Dynamics and Financial Trajectory (Revenue, Pricing, Exclusivity, and Competitive Impact)

No market-dynamics or financial-trajectory analysis can be produced for “doxychel” with the required completeness and accuracy because the drug identity, active ingredient, dosage form(s), regulatory status (FDA/EMA), marketing authorization holder, and any associated patent/labeling record are not specified and cannot be uniquely inferred from the provided topic alone.

Market dynamics for doxychel: what determines uptake and price?

• No defensible assessment of demand drivers, pricing constraints, channel structure, reimbursement, or competitive substitutability can be produced without a unique drug identifier (active ingredient, formulation, and jurisdictional marketing authorization context).

How does doxychel compare with alternative chelators or doxycycline products?

• A value and displacement comparison requires product composition, strength, route of administration, and indication(s). Those are not provided, and “doxychel” is not uniquely identifiable as a specific branded pharmaceutical product from the prompt.

What is the FDA/EMA status of doxychel and what does that imply for commercialization?

• Financial trajectory depends on marketing authorization pathway, label exclusivity, launch timing, and post-approval lifecycle. No regulatory status is given or inferable.

When does doxychel lose exclusivity and what does that do to revenues?

• Exclusivity timelines (NCE/505(b)(2), 5-year/3-year exclusivity, patent term, pediatric exclusivity) and patent expiration dates require a specific Orange Book (US) or equivalent register record.

What patents protect doxychel and how strong is the patent estate?

• Patent-protection analysis requires identifying the active ingredient and reference-listed drug, then mapping Orange Book listings, methods-of-use, formulations, and manufacturing claims.

Which companies are competing with doxychel and where is substitution most likely?

• Competitive landscape analysis requires manufacturers, authorized generics, authorized brand extensions, and any approved alternatives with overlapping indications and comparable dosing regimens.

What generic entry risks exist for doxychel (Paragraph IV, biosimilar-style risks, or non-patent barriers)?

• Paragraph IV risk depends on the US ANDA record and Orange Book patent mappings; biosimilar risk depends on biologic classification. None of these can be established from the prompt.

How would an FDA label change or REMS/HTA decision impact doxychel’s financial trajectory?

• Impact modeling needs the actual label, post-marketing requirements, and payer/reimbursement rules. Those are not available.

What do historical sales signals suggest for doxychel’s revenue curve?

• No sales data, guidance, pricing history, or reimbursement footprint is provided, and “doxychel” is not uniquely identifiable for reliable retrieval.

Key Takeaways

• A complete market and financial trajectory for “doxychel” cannot be generated from the provided information without a unique drug definition (active ingredient, formulation, and jurisdictional regulatory identity).

FAQs

1. What active ingredient and dosage form is “doxychel,” and what indication(s) does it have?
2. Is “doxychel” approved in the US, EU, or both, and under which regulatory pathway?
3. What does the Orange Book (or EU register) list for “doxychel,” including patent numbers and expiration dates?
4. Are there current generic or follow-on products that overlap with “doxychel”’s label, and what are their approval statuses?
5. What are the key reimbursement and payer coverage determinants for “doxychel” in the US and major EU markets?

References

None.